90 results on '"Ziegelmann MJ"'
Search Results
2. Health Care Provider Knowledge and Attitudes about Erectile Dysfunction and Penile Implants
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Roshandel, MR, Ziegelmann, MJ, Helo, S, Köhler, TS, and Collins, CS
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- 2022
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3. Chlorhexidine gluconate application, diabetes, revision surgery, and extended operative time increase risk for penile implant infection.
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Helo S, Bonakdar Hashemi M, Ziegelmann MJ, Lybbert DT, Piraino J, Guillen Lozoya AH, and Köhler TS
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Background: Chlorhexidine gluconate (CHG) (0.05%) has recently been suggested as a dip and irrigation solution at time of inflatable penile prosthesis (IPP) surgery., Aim: This study evaluated infection rates before and after implementing CHG protocol while investigating concurrent risk factors contributing to post operative infections., Methods: A retrospective, consecutive cohort study was performed that included patients who underwent insertion of a Coloplast Titan IPP including both virgin and revision cases between 2021 and 2024. Cases performed from January 2021 to August 2022 utilized rifampin/gentamicin for dip and vancomycin/gentamicin for irrigation (ABX), whereas those from October 2022 to May 2024 utilized CHG for both dip and irrigation. Perioperative risk factors including dip and irrigation solution used at time of surgery were compared between groups., Outcomes: We defined the incidence of postoperative infection and risk factors associated with infection in each group., Results: The incidence of infection was significantly higher in the 0.05% CHG group (13/377) compared to the ABX group (0/320) (P < .001). When analyzed separately by subgroup, virgin cases treated with CHG for dip and irrigation demonstrated a significantly higher infection rate (7/315) compared to those in the ABX group (0/280) (P = .012). Similarly, in revision cases, the CHG group also exhibited a significantly higher infection rate (0/40) than the ABX group (6/62) (P = .043).Univariable analysis of the CHG cohort identified three significant risk factors for infection: diabetes mellitus (DM), extended operative time (OP), and revision surgery (P = .003, .001, and < .001, respectively). Multivariable regression analysis revealed that patients with DM had a 5.7-fold increased risk of infection (OR: 5.70, P = .004), while those undergoing revision surgery faced a 5.3-fold higher risk (OR: 5.26, P = .004). Additionally, each minute increase in OP was associated with a 1% higher infection risk (OR: 1.01 per minute, P = .007). These associations remained significant after adjusting for all variables in the model., Clinical Implications: Prosthetic surgeons should be cautious about adopting 0.05% CHG for both dip and irrigation in the absence of strong clinical evidence demonstrating its non-inferiority to antibiotic solutions., Strengths and Limitations: This is the first clinical study reporting infection rates after IPP surgery using 0.05% CHG for both dip and irrigation. While retrospective and non-randomized, we present a relatively large sample size of patients., Conclusions: Our findings identify four risk factors for penile prosthesis infection: usage of the 0.05% CHG solution for dip and irrigation solution of Coloplast hydrophilic-coated devices, DM, revision surgery, and extended OP., (© The Author(s) 2025. Published by Oxford University Press on behalf of The International Society for Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2025
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4. Selective penile artery angioembolization for high flow priapism - a step-by-step overview for the non-radiologist.
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Bretzman JP, Ziegelmann MJ, and Reisenauer CJ
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Introduction: Selective angioembolization for high flow priapism (Step-by-step guide)., Aim: Describe the indications and techniques of angioembolization for high flow priapism., Methods: We outline patient selection, preparation, technique, outcomes, and potential complications of angioembolization for high flow priapism as supported by the literature., Main Outcome Measure: The effectiveness of embolization for treating high flow priapism., Results: Transarterial embolization is minimally invasive, low risk, and effective method from managing high flow priapism. Success rates range from 70% to 87% depending on the type of agent used for embolization. Side effects include erectile dysfunction with a reported rate of 7%-19%. Complications may be mitigated by embolizing as selectively as possible and using temporary embolic agents., Conclusion: Embolization is a safe and effective treatment for nonischemic, high flow priapism in patients who have not responded to conservative management., (© The Author(s) 2025. Published by Oxford University Press on behalf of The International Society for Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2025
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5. Reply to Editorial Comment on "Discrepancy Between Patient Versus Provider Assessment of Erection Quality".
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Lee MS, Yang DY, and Ziegelmann MJ
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Competing Interests: Declaration of Competing Interest The authors have no conflict of interest to declare.
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- 2025
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6. Discrepancy Between Patient vs Provider Assessment of Erection Quality.
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Lee MS, Ziegelmann MJ, Ellythy LM, Sax-Bolder AN, Guillen Lozoya AH, Köhler TS, Helo S, and Yang DY
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Objective: To characterize the discrepancy between patients' and providers' assessments of erection rigidity and its association with patient characteristics and penile ultrasound parameters., Methods: Patients presenting for penile Doppler ultrasound between July 2022 and October 2023 were reviewed retrospectively. After intracavernosal injection, patients and providers independently rated erection rigidity from 1 to 10 prior to ultrasound. We defined discrepancy as a difference of 2 out of 10 or greater between the two assessments. Chi-squared and Mann-Whitney U tests were used for hypothesis testing., Results: 65/297 (22%) of patients demonstrated a discrepancy in perceived erection quality. 58/65 (89%) of these patients rated their erections lower than their providers. There was a higher incidence of erectile dysfunction as the primary diagnosis in the discrepant group as compared to the concordant group (P = .01). The discrepant group also showed a higher resistive index on penile ultrasound (P = .04), with no difference in peak systolic velocity, end diastolic velocity, or other clinical variables between the two groups., Conclusion: Discrepancy in perceived erection rigidity was mainly driven by lower patient perception, although these patients had noninferior penile hemodynamics to their peers. These findings underscore the influence of subjective perception of virility on sexual function. It is critical for clinicians to identify patients with poor perception of erectile function out of proportion to physiologic abnormalities. Thoughtful counseling about treatment goals and expectations, emphasizing functional outcomes, and adjunctive treatments such as sex therapy or psychotherapy are critical to therapeutic success in this population., Competing Interests: Declaration of Competing Interest The authors have no conflict of interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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7. Current and Future Directions of Technology in Assessment of Peyronie's Disease.
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Mian AH and Ziegelmann MJ
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- Artificial Intelligence standards, Ultrasonography standards, Humans, Magnetic Resonance Imaging standards, Elasticity Imaging Techniques standards, Photography standards, Penile Induration diagnostic imaging, Diagnostic Imaging methods, Diagnostic Imaging standards, Diagnostic Imaging trends
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Purpose of Review: This review assesses the effectiveness of various imaging modalities for diagnosing and managing Peyronie's disease (PD), exploring their clinical utility and limitations., Recent Findings: Ultrasonography, currently the only modality endorsed by the American Urological Association, effectively detects calcifications and assesses vascular status but struggles with identifying non-palpable plaques. Computed tomography and magnetic resonance imaging provide detailed anatomical views but are costly along with other deterring factors. Autophotography and 3-dimensional imaging offer convenient home assessments but with variable accuracy. Elastography improves upon traditional ultrasonography, while emerging AI technologies show promise for automating precise curvature assessments, pending further validation. A combined approach tailored to each individual patient based on their needs enhances diagnostic accuracy. Supplementing ultrasonography with elastography and potentially AI could improve diagnostic outcomes and better guide treatment decisions. Continued research is vital to integrate these advancements into standard clinical practice and develop updated standardized protocols., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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8. Lessons learned from the Sexual Medicine Society of North America fellowship bootcamp.
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Köhler TS, Bonakdar Hashemi M, Helo S, Morey AF, Nelson CJ, Trost L, Ziegelmann MJ, and Khera M
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- Humans, Male, Female, Societies, Medical, Urology education, North America, Sexual Dysfunction, Physiological therapy, Surveys and Questionnaires, Sexology education, Fellowships and Scholarships, Curriculum
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Background: Sexual Medicine Society of North America (SMSNA) fellowships offer variable experience in sexual health domains: erectile dysfunction, Peyronie's disease, male infertility, male hypogonadism (low testosterone), reconstruction (including male incontinence), benign prostatic hyperplasia, gender affirmation surgery, sexual mental health, and female sexual dysfunction., Aim: To evaluate baseline and postbootcamp understanding and trust in these domains., Methods: In 2023, 28 of 31 urologists currently enrolled in SMSNA-endorsed fellowships participated in a 3.5-day training bootcamp in Minneapolis, Minnesota. Participants were asked to complete pre- and postbootcamp surveys. The bootcamp curriculum offered American Urological Association guidelines and case-based lectures, hands-on clinical training with cadavers (penile surgery) and models (collagenase training), and interaction with industry., Outcomes: Changes in knowledge, independence, and trust in performing the procedures, as well as billing issues and feedback for future bootcamps., Results: Prebootcamp surveys revealed vastly varied residency experience. Reported time with an expert faculty member was greatest for benign prostatic hyperplasia and least for female sexual dysfunction, gender affirmation surgery, and low testosterone. The lowest prebootcamp confidence in performing surgery independently was for penile grafting procedures and elevating the neurovascular bundle. Postbootcamp results revealed several areas of significant improvement in confidence (P ≤ .03): intralesional injections for Peyronie's disease, manual modeling, penile plication, penile grafting procedures, and elevating the neurovascular bundle. There was a trend for improved confidence with the insertion of inflatable (P = .05) and semirigid (P = .08) penile prostheses. Nonsignificant improvement occurred in artificial urinary sphincter surgery (P = .12). Participants graded the bootcamp very highly and requested that next year's bootcamp have more content on female sexual dysfunction, male incontinence, and low testosterone, as well as more hands-on skills sessions and case-based lecture formats., Clinical Implications: Offering a bootcamp with hands-on instruction could significantly improve urologists' knowledge and confidence., Strengths and Limitations: As the main strength, this study was the first specialized bootcamp for urologists in the subject of men's health, taking into account hands-on and cadaver laboratories, as well as highlighting industrial and pharmaceutical products. The small sample size was the major limitation., Conclusions: Current SMSNA fellows present with varied levels of experience and confidence across sexual health domains. Notable confidence improvements were seen with topics that combined didactic lectures with hands-on trainings., (© The Author(s) 2024. Published by Oxford University Press on behalf of The International Society for Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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9. Commentary on 'Anatomic considerations of inflatable penile prosthetics: lessons gleaned from surgical body donor workshops'.
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Ziegelmann MJ
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- Humans, Male, Tissue Donors, Prosthesis Design, Erectile Dysfunction surgery, Penile Prosthesis, Penile Implantation methods, Penis surgery, Penis anatomy & histology
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- 2024
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10. Editorial Commentary.
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Ziegelmann MJ
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- 2024
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11. Variability in Methodology of Erectile Dysfunction Regenerative Therapy Trials on ClinicalTrials.gov.
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Gutierrez WR, Gross MS, and Ziegelmann MJ
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- Male, Humans, Extracorporeal Shockwave Therapy methods, Regenerative Medicine methods, Stem Cell Transplantation, Erectile Dysfunction therapy, Platelet-Rich Plasma, Clinical Trials as Topic
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Objective: To evaluate the variability in the criteria of erectile dysfunction (ED) regenerative therapy trials registered on ClinicalTrials.gov., Methods: Interventional trials on ClinicalTrials.gov with the keywords "erectile dysfunction" and variations of "shockwave," "platelet rich plasma," "stem cell," "regenerative," and "restorative" were examined. Inclusion/exclusion criteria and primary/secondary outcomes were compared between extracorporeal shockwave therapy (ESWT), platelet rich plasma and stem cell injections (PRP/SC), and other regenerative therapies (ORT) groups., Results: Of the 92 trials analyzed, International Index of Erectile Function (IIEF) score was the most common primary outcome (72%), with a higher prevalence in ESWT trials than PRP/SC or ORT trials (89% vs 44% and 58%, P <.001). Safety/tolerability was a primary outcome for 44% of PRP/SC trials and 25% of ORT trials but no ESWT trials (P <.001). ESWT trials more frequently had sexual/romantic relationship-based inclusion criteria and cancer treatment-related exclusion criteria than PRP/SC and ORT trials., Conclusion: There is substantial variability in the inclusion/exclusion criteria and outcome measures among ED regenerative therapy trials. ESWT trials most frequently utilized IIEF and had the strictest inclusion/exclusion criteria, suggesting more rigorous and functional outcome-based studies. Conversely, PRP/SC and ORT trials, but not ESWT trials, had safety/tolerability as a primary outcome, likely due to the experimental nature of these therapies. The variability in inclusion/exclusion criteria and outcome measures limits comparison of the various ED regenerative therapies., Competing Interests: Declaration of Competing Interest Dr Gross is a consultant for Coloplast. Dr Ziegelmann is a consultant for Endo International. Wade Gutierrez has no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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12. Complications and troubleshooting in primary penile prosthetic surgery-a review.
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Byrne ER, Ungerer GN, Ziegelmann MJ, and Kohler TS
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- Male, Humans, Penis surgery, Patient Satisfaction, Penile Implantation adverse effects, Penile Implantation methods, Erectile Dysfunction etiology, Erectile Dysfunction surgery, Penile Prosthesis adverse effects
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Penile implant surgery is the gold standard to treat erectile dysfunction with success rates of over 90%. The first penile implants were developed in the early 1900s. Since then, several types of implants have been developed including malleable implants, two-piece inflatable implants, and three-piece inflatable implants. The three-piece inflatable penile prosthesis, which was introduced in 1973, is the most widely used type of penile implant in the United States. Penile implant surgery has undergone numerous advancements over the years, improving outcomes and patient satisfaction. However, as with any surgical procedure, there are risks and complications associated with penile implant surgery. It is important for surgeons to understand these potential complications and to have strategies in place to manage and prevent them to achieve the best possible outcomes for their patients., (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)
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- 2023
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13. Penile indentation and hourglass deformities with Peyronie's disease-what can we reasonably offer our patients?
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Ziegelmann MJ
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- Male, Humans, Penis surgery, Patients, Penile Induration surgery
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- 2023
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14. Comparison of patient-reported outcomes after penile prosthesis placement in men with and without Peyronie's disease.
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Ziegelmann MJ, Langbo WA, Bajic P, and Levine LA
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- Male, Humans, Retrospective Studies, Penis surgery, Patient Reported Outcome Measures, Patient Satisfaction, Penile Induration complications, Penile Induration surgery, Penile Prosthesis, Penile Implantation methods, Erectile Dysfunction etiology, Erectile Dysfunction surgery
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We evaluated outcomes in patients undergoing penile prothesis (PP) implantation for erectile dysfunction (ED) and concurrent Peyronie's Disease (PD). A clinician-developed survey to assess satisfaction was sent to 354 patients who underwent PP placement from 2012-2018 by a single-surgeon. Results were compared based on the presence or absence of concurrent PD. 79 patients completed the survey (response rate 22%), including 38 patients (48%) with concurrent ED and PD (ED/PD). Mean follow-up was 31 months (standard deviation 19). 87% felt their condition was "very much" or "much" improved. There was no significant difference in patient-reported overall satisfaction with their PP or satisfaction with current penile length/girth based on the presence or absence of PD. 87% of patients with PD were satisfied with their degree of penile straightening after PP plus or minus concurrent straightening maneuvers such as modeling, plication, or incision/grafting. Sub-group analyses were performed to evaluate outcomes in those with concurrent PD/ED who required plaque incision/grafting at the time of PP placement for more severe deformity (n = 19). 47% of these patients were dissatisfied with their current penile length, compared with only 16% of those patients with PD/ED who did not require grafting (p = 0.05). In conclusion, the presence of PD alone may not impact PP satisfaction, but patients with more severe baseline deformity who require incision/grafting may be less satisfied with outcomes including penile length., (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)
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- 2023
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15. Testicular Pain - Not Always What it Seems: A Cross-Sectional Assessment of Patients Presenting for Chronic Scrotal Content Pain at a Tertiary Care Center.
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Sischka MF, Tentis ER, Helo S, Kohler TS, Collins CS, and Ziegelmann MJ
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- Male, Humans, Tertiary Care Centers, Retrospective Studies, Cross-Sectional Studies, Scrotum, Pelvic Pain diagnosis, Pelvic Pain etiology, Pelvic Pain therapy, Genital Diseases, Male surgery, Testicular Diseases complications, Testicular Diseases diagnosis, Testicular Diseases surgery, Chronic Pain diagnosis, Chronic Pain etiology, Chronic Pain surgery, Skin Diseases
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Objective: To review historical and examination findings in patients presenting to a tertiary care center for evaluation of Chronic Scrotal Content Pain (CSCP) defined by persistent/bothersome pain present for > 3-months., Methods: We performed a retrospective chart review of all patients presenting to our medical center for evaluation of CSCP. Pertinent information collected included historical data, physical examination findings, laboratory and imaging results, and treatments recommended by the assessing physician. The data was summarized to present a cross-sectional representation of patients presenting for CSCP., Results: 110 patients were identified. 80 patients (73%) had seen at least one prior urologist. 26 patients (24%) had undergone a prior unsuccessful surgical intervention for CSCP. Reproducible tenderness was present in 67% of patients including testicular tenderness in 50 (45%), epididymal tenderness in 60 (55%), and spermatic cord tenderness in 31 patients (28%). 33% of patients did not have any reproductible scrotal content tenderness on physical examination. Surgery was recommended in 57/110 patients (52%), including microdenervation in 22%. Musculoskeletal etiologies were suspected based on specific aspects of the history and physical examination in 43 patients (39%), prompting additional evaluation and/or referrals., Conclusion: CSCP presents with a wide array of symptoms and many patients do not have reproducible findings on examination, suggesting alternative sources of pain such as referred pain from musculoskeletal causes. The history and physical examination should include assessments for concurrent abdominal, back, hip, and other genital/pelvic pain that may suggest alternative diagnoses and referrals for appropriate treatment., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2023
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16. Postoperative Opioid Prescribing Following Outpatient Male Urethral Surgery: Evidence for Change.
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Findlay BL, Bearrick EN, Hebert KJ, Britton CJ, Ziegelmann MJ, Anderson KT, and Viers BR
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- Humans, Male, Oxycodone therapeutic use, Pain, Postoperative drug therapy, Outpatients, Practice Patterns, Physicians', Bupivacaine therapeutic use, Analgesics, Opioid therapeutic use, Tramadol therapeutic use
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Introduction: Surgeons play a central role in the opioid epidemic. We aim to evaluate the efficacy of a standardized perioperative pain management pathway and postoperative opioid requirements in men undergoing outpatient anterior urethroplasty at our institution., Methods: Patients undergoing outpatient anterior urethroplasty by a single surgeon from August 2017 to January 2021 were prospectively followed. Standardized nonopioid pathways were implemented based on location (penile vs bulbar) and need for buccal mucosa graft. A practice change in October 2018 transitioned (1) from oxycodone to tramadol, a weak mu opioid receptor agonist, postoperatively and (2) from 0.25% bupivacaine to liposomal bupivacaine intraoperatively. Postoperative validated questionnaires included 72-hour pain level (Likert 0-10), pain management satisfaction (Likert 1-6), and opioid consumption., Results: A total of 116 eligible men underwent outpatient anterior urethroplasty during the study period. One-third of patients did not use opioids postoperatively, and nearly 78% of patients used ≤5 tablets. The median number of unused tablets was 8 (IQR 5-10). The only predictor for use of >5 tablets was preoperative opioid use (75% vs 25%, P < .01). Overall, patients using tramadol postoperatively reported higher satisfaction (6 vs 5, P < .01) and greater percentages of pain reduction (80% vs 50%, P < .01) compared to those using oxycodone., Conclusions: For opioid-naïve men, 5 tablets or less of opioid medication with a nonopioid care pathway provides satisfactory pain control following outpatient urethral surgery without excessive overprescribing of narcotic medication. Overall, multimodal pain pathways and perioperative patient counseling should be optimized to further limit postoperative opioid prescribing.
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- 2023
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17. Reply by Authors.
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Findlay BL, Bearrick EN, Hebert KJ, Britton CJ, Ziegelmann MJ, Anderson KT, and Viers BR
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- 2023
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18. The "Minimal-Touch" Technique for Artificial Urinary Sphincter Placement: Description and Outcomes.
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Ziegelmann MJ, Hebert KJ, Linder BJ, Rangel LJ, and Elliott DS
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Objective: The study aimed to describe "minimal-touch" technique for primary artificial urinary sphincter placement and evaluate early device outcomes by comparing it with a historical cohort., Materials and Methods: We identified patients who underwent primary artificial urinary sphincter placement at our institution from 1983 to 2020. Statistical analysis was performed to identify the rate of postoperative device infection in patients who underwent minimal touch versus those who underwent our traditional technique., Results: 526/2601 total procedures (20%) were performed using our "minimal-touch" approach, including 271/1554 patients (17%) who underwent primary artificial urinary sphincter placement over the study period. Around 2.3% of patients experienced device infection after artificial urinary sphincter procedures. In the "minimal-touch" era, 3/526 patients (0.7%) experienced device infection, including 1/271 (0.4%) of those with primary artificial urinary sphincter placement. In comparison, 46/2075 patients (2.7%) experienced device infection using the historical approach, with 29/1283 (2.3%) of primary artificial urinary sphincter placements resulting in removal for infection. Notably, 90% of device infections occurred within the first 6 months after primary placement. The difference in cumulative incidence of device infections at 12 months did not meet our threshold for statistical significance for either the total cohort of all AUS procedures (primary and revision) or the sub-group of only those patients undergoing primary artificial urinary sphincter placement (Gray K-sample test; P=.13 and .21, respectively)., Conclusion: The "minimal-touch" approach for artificial urinary sphincter placement represents an easy-to-implement modification with potential implications on device outcomes. While early results appear promising, longer-term follow-up with greater statistical power is needed to determine whether this approach will lower the infection risk.
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- 2023
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19. EDITORIAL COMMENT.
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Ziegelmann MJ and Byrne E
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- 2022
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20. A Consistent Lack of Consistency in Defining the Acute and Chronic Phases of Peyronie's Disease: A Review of the Contemporary Literature.
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Piraino J, Chaudhary H, Ames K, Okoye F, Sterling M, Clavell-Hernandez J, Levine L, and Ziegelmann MJ
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- Male, Humans, Penile Induration therapy
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Introduction: Treatment recommendations for Peyronie's Disease (PD) differ based on whether a patient is in the acute/active versus chronic/stable phase of the disease, yet there are no agreed upon criteria for defining these clinical entities., Objectives: To review the criteria used to define acute and chronic phase PD in modern PD intervention studies., Methods: We performed a search engine review to identify indexed publications for PD intervention studies and review articles / meta-analyses from the year 2011-2020. Outcomes results were catalogued and summarized across articles. As a result of the substantial heterogeneity of outcome measures and follow-up intervals, meta-analytic techniques were not applied to the data analysis., Results: We identified a total of 104 studies that met inclusion criteria and had available information for review (n = 79 primary intervention studies; n = 25 review articles/meta-analyses/guidelines). Among the queried studies, we were unable to identify a consensus with respect to the criteria used to define acute and chronic phases of PD. 33% of primary intervention studies did not specifically define their criteria for acute and chronic phase PD, despite referencing these populations as part of the inclusion criteria in many instances. Studies used heterogenous criteria including total symptom duration, duration of "stable" symptoms, and presence/absence of pain., Conclusion: Due to varying definitions across the literature, we were unable to create a standardized definition of acute and chronic phase Peyronie's in terms of time. Our findings emphasize the need for greater consensus in defining the treatment cohorts with future studies that assess treatment for men with PD., Competing Interests: Conflicts of interest: Matthew Ziegelmann is a paid consultant for Endo Pharmaceuticals. Laurence Levine is a paid consultant for Boston Scientific., (Copyright © 2022, International Society for Sexual Medicine. Published by Elsevier.)
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- 2022
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21. Penile Prosthesis Implantation Combined With Grafting Techniques in Patients With Peyronie's Disease and Erectile Dysfunction: A Systematic Review.
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Sokolakis I, Pyrgidis N, Ziegelmann MJ, Mykoniatis I, Köhler TS, and Hatzichristodoulou G
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- Aged, Humans, Male, Middle Aged, Patient Satisfaction, Erectile Dysfunction etiology, Erectile Dysfunction surgery, Penile Implantation methods, Penile Induration, Penile Prosthesis adverse effects
- Abstract
Introduction: Penile prosthesis (PP) implantation combined with grafting techniques is indicated in patients with Peyronie's disease (PD) and erectile dysfunction (ED) nonresponsive to medical and conservative treatment that present with residual penile curvature greater than 30°, severe penile deformity or significant penile shortening., Objectives: To address the preoperative evaluation, the surgical procedure and the functional outcomes of grafting techniques combined with PP implantation in patients with PD and concomitant ED and to provide future perspectives on the matter., Methods: We performed a systematic review of the literature based on the PRISMA statement (PROSPERO ID: CRD42021224517). Records were identified by searching Medline, Scopus, The Cochrane Library and Web of Science databases as well as sources of gray literature from inception to December 2020. The quality of all included records was assessed based on a modified version of the Newcastle-Ottawa Scale for cohort studies., Results: A total of 935 patients with a mean age of 59.6 ± 9.2 years from 23 studies were included in this systematic review. All studies reported excellent short- and long-term postoperative results, as well as high satisfaction rates ranging from 80 to 100%. A mean increase of 2.7 ± 1.4 cm in penile length was observed. Among different grafting materials and different types of PP, no significant differences in terms of preoperative, perioperative and postoperative functional outcomes or complications were demonstrated. Still, the operative time was shorter in studies applying the collagen fleece TachoSil., Conclusions: PP implantation combined with grafting is a safe and highly effective surgical procedure in patients with PD and concomitant ED. All grafting materials provide similar beneficial outcomes, but TachoSil subsequently reduces the operative time and does not require suturing. Still, no definite conclusions can be drawn regarding the superiority of one grafting technique over the other, as randomized clinical trials are lacking. Sokolakis I, Pyrgidis N, Ziegelmann M, et al. Penile Prosthesis Implantation Combined With Grafting Techniques in Patients With Peyronie's Disease and Erectile Dysfunction: A Systematic Review. Sex Med Rev 2022;10:444-452., (Copyright © 2021 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2022
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22. A Critical Analysis of Reporting in Systematic Reviews and Meta-Analyses in the Peyronie's Disease Literature.
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Bole R, Gottlich HC, Ziegelmann MJ, Corrigan D, Levine LA, Mulhall JP, and Bajic P
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- Bibliometrics, Evidence-Based Medicine, Humans, Male, Meta-Analysis as Topic, Research Design, Systematic Reviews as Topic, Penile Induration
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Background: Despite an increasing number of publications on Peyronie's disease (PD), evidence-based clinical decision-making remains challenging due to the small number of well-designed clinical trials., Aim: To perform a critical analysis of reporting quality in PD systematic reviews (SR) and meta-analyses (MA)., Methods: Study protocol registration was performed on the Open Science Framework platform. In January 2021, a systematic electronic search of the Medline/PubMed, Embase, Ovid, Scopus, Joanne Briggs Institute, and Cochrane databases was performed. Search terms included "Peyronie's disease" and "systematic review OR meta-analysis OR meta-analysis." Eligibility criteria were English-language, relevance to PD and specification of "systematic review" or "meta-analysis" in the title or abstract. Oxford Center for Evidence-Based Medicine levels of evidence were used to classify original studies reviewed within each publication. Risk of bias was assessed using the ROBIS tool. Data were tabulated and reported as means with standard deviation, median with interquartile range and t-testing as appropriate. Strength of association between variables was calculated using Pearson correlation coefficient. Statistical analyses were performed on RStudio (version 1.4.1106)., Outcomes: Outcomes included review type, level of evidence, authorship, journal, publication date, "A MeaSurement Tool to Assess systematic Reviews" (AMSTAR-2) score and "Preferred Reporting Items for Systematic Reviews and Meta-Analyses" (PRISMA) score., Results: From 1974 to 2021, 340 articles were identified. After review, 17 full length articles were included. Thirteen were SR, 2 MA and 2 was combined. Significant heterogeneity was seen in evidence level of included studies. There was median 54% adherence to AMSTAR-2 criteria and 74% adherence to PRISMA criteria. Overall AMSTAR-2 confidence rating was Critically Low in 11 of 17 studies. Correlation analysis revealed very high positive association between AMSTAR 2 and PRISMA adherence (+0.95). ROBIS revealed "High" concern regarding methods used to collect data and appraise 12/17 studies (71%), and "High" concern regarding synthesis and findings in 8 of 17 studies (47%)., Clinical Implications: Many SR include markedly heterogenous levels of evidence and fail to meet accepted methodological criteria for reporting., Strengths and Limitations: Main strengths include extensive literature review and analysis of standardized study reporting. One limitation is that aggregate scoring of AMSTAR-2 and PRISMA is not intended as primary method of quality assessment; however effect was minimized by reporting critical domains, overall quality assessments and specifics on globally poorly reported domains., Conclusion: More high quality randomized controlled PD trials are necessary; SR and MA should focus on these studies alone. Bole R, Gottlich HC, Ziegelmann MJ, et al. A Critical Analysis of Reporting in Systematic Reviews and Meta-Analyses in the Peyronie's Disease Literature. J Sex Med 2022;19:629-640., (Copyright © 2022 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2022
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23. A Contemporary Analysis of Ureteral Reconstruction 30-Day Morbidity Utilizing the National Surgical Quality Improvement Program Database: Comparison of Minimally Invasive vs Open Approaches.
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Hebert KJ, Linder BJ, Gettman MT, Ubl D, Habermann EB, Lyon TD, Ziegelmann MJ, and Viers BR
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- Humans, Length of Stay, Minimally Invasive Surgical Procedures, Morbidity, Postoperative Complications etiology, Retrospective Studies, Quality Improvement, Ureter surgery
- Abstract
Objectives: To characterize 30-day morbidity of upper ureteral reconstruction (UUR) and lower ureteral reconstruction (LUR) surgery by comparing open and minimally invasive surgery (MIS) approaches using a national surgical outcomes registry. Methods: The American College of Surgeons National Surgical Quality Improvement Program database was reviewed for patients who underwent UUR and LUR between 2007 and 2017. Primary endpoints included 30-day complications, transfusion, readmission, return to operating room (ROR), and prolonged postoperative length of stay (LOS). Multivariable logistic regression was performed to observe the association of MIS approach on 30-day outcomes. Results: Three thousand forty-two patients were identified with 2116 undergoing UUR and 926 undergoing LUR. Of 2116 patients undergoing UUR, 1733 (82%) were performed through an MIS approach. On multivariable analysis, open approach for UUR was associated with increased odds of any 30-day complication (odds ratio (OR) 1.6 [1.1-2.4]; p = 0.014), major complication (OR 1.8 [1.04-3.0]; p = 0.034), transfusion (OR 3.7 [1.2-11.5]; p = 0.025), ROR (OR 2.0 [1.0-3.9]; p = 0.047), and prolonged LOS (OR 5.4 [3.9-7.6]; p < 0.001). Of the 926 patients undergoing LUR, 458 (49%) were performed through an MIS approach. On multivariable analysis, open approach for LUR was associated with increased odds of any 30-day complication (OR 1.5 [1.1-2.1]; p = 0.028), minor complication (OR 1.7 [1.1-2.6]; p = 0.02), transfusion (OR 8.1 [2.7-23.7]; p < 0.001), and prolonged LOS (OR 4.2 [2.4-7.3]; p < 0.001). Conclusion: Utilization of a national surgical database revealed an open approach was associated with increased 30-day morbidity across multiple postoperative outcome measures. These findings suggest an MIS approach should be considered, when feasible, for upper and lower ureteral reconstruction.
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- 2022
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24. Surgical Correction of Adult Congenital Penile Curvature: A Systematic Review.
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Britton CJ, Jefferson FA 4th, Findlay BL, Sharma V, Hernandez JC, Levine LA, and Ziegelmann MJ
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- Adult, Humans, Male, Patient Satisfaction, Penis abnormalities, Penis surgery, Reproducibility of Results, Treatment Outcome, Penile Induration surgery
- Abstract
Background: Congenital penile curvature (CPC) is corrected surgically by various corporoplasty or tunica albuginea plication techniques, but the optimal surgical approach is not well-defined., Aim: To provide a comprehensive evaluation of the published literature pertaining to outcomes with penile plication and corporoplasty techniques for surgical management of CPC. To determine if plication or corporoplasty offers superior outcomes in surgical correction of CPC., Methods: A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Checklist. The following databases were queried from inception to March 18, 2020 to search for studies describing surgical treatment of CPC: Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus., Outcomes: Objective and subjective postoperative outcomes including penile straightening, shortening, penile sensory changes, and reoperation rates for both corporoplasty and tunica albuginea plication were summarized., Results: Fifty-five articles comprising 2,956 patients with CPC who underwent a plication procedure (n = 1,375) or corporoplasty (n = 1,580) were included. The definition of "treatment success" varied widely and most often involved subjective patient reporting (22 studies; 40%) or objective assessment (15 studies; 27%). We considered curvature correction to be satisfactory if there was self-reported patient satisfaction or residual curvature after correction of <20˚. Reported rates of successful straightening ranged from 75 to 100% and 73 to 100% for plication and corporoplasty, respectively. A comprehensive and accurate assessment of surgical outcomes for CPC correction, such as satisfactory penile straightening, reoperation rates, glans sensory changes, and other complications was limited by significant inter-study heterogeneity with respect to the reporting of treatment outcomes., Clinical Implications: While both plication and corporoplasty appear to be safe and effective options in the treatment of CPC, definitive conclusions cannot be drawn with respect to treatment superiority due to low-quality study design, methodology flaws, and significant heterogeneity in reporting., Strength & Limitations: This report represents the most comprehensive review of CPC surgical management. However, there is a significant lack of standardization in the reporting of treatment outcomes for CPC, thereby limiting the reliability of the published data summarization encompassed by our review., Conclusion: Both plication and corporoplasty demonstrate high success rates and relatively low complication rates in the treatment of CPC, albeit with low-level evidence available in most research publications. Robust comparison of the surgical techniques used to correct CPC is limited by significant variation in reporting methods used in the literature. C. J. Britton, F. A. Jefferson, B. L. Findlay, et al. Surgical Correction of Adult Congenital Penile Curvature: A Systematic Review. J Sex Med 2022;19:364-376., (Copyright © 2021 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
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25. Incidence of Venous Thromboembolism and Safety of Perioperative Subcutaneous Heparin During Inflatable Penile Prosthesis Surgery.
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Hebert KJ, Findlay BL, Yang DY, Houlihan MD, Bole R, Avant RA, Andrews JR, Jimbo M, Ziegelmann MJ, Helo S, and Köhler TS
- Subjects
- Anticoagulants administration & dosage, Drainage, Hematoma etiology, Heparin administration & dosage, Humans, Injections, Subcutaneous, Male, Middle Aged, Postoperative Complications etiology, Postoperative Complications prevention & control, Postoperative Period, Retrospective Studies, Risk Assessment, Risk Factors, Scrotum, Anticoagulants therapeutic use, Heparin therapeutic use, Penile Prosthesis, Prosthesis Implantation adverse effects, Venous Thromboembolism etiology, Venous Thromboembolism prevention & control
- Abstract
Objective: To identify the incidence of venous thromboembolism (VTE) risk factors, postoperative VTE, and to assess the morbidity of perioperative pharmacologic VTE prophylaxis in men undergoing inflatable penile prosthesis (IPP) surgery., Methods: We retrospectively reviewed 215 patients undergoing IPP surgery between July 2017 and June 2019. Univariate and multivariate statistical analyzes were performed to assess pre-operative Caprini risk score and compare post-operative day 0 scrotal drain output, scrotal hematoma formation, and VTE in men who received subcutaneous heparin (SqH) vs those who did not receive SqH., Results: Of 215 IPP patients, 84% were classified as high or highest risk for VTE utilizing the Caprini risk score. A total of 119 (55%) received perioperative SqH with or without additional anti-thrombotics. Post-operative day 0 scrotal drain output was higher in those who received SqH compared to those who did not receive SqH, 99.9 mL vs 75.6 mL, respectively (P = .001). Minor scrotal hematomas occurred in similar rates in patients who received perioperative SqH vs those who did not, 3.8% vs 6.3%, respectively (P = .38). Similar results were found on subgroup analysis when eliminating patients who received SqH concurrently with other anti-thrombotics. The overall rate of postoperative VTE was 0.9%. No post-operative infections occurred., Conclusion: Patients undergoing IPP surgery are at elevated risk for VTE. To our knowledge, this is the first study showing SqH use in the perioperative IPP surgery setting is safe when used in conjunction with a scrotal drain. Preoperative VTE risk stratification may be performed and can be used to guide clinical decision making regarding pharmacologic prophylaxis., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
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26. Clinical Challenges With Penile Prosthesis Placement and Peyronie's Disease.
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Ziegelmann MJ and Habashy E
- Subjects
- Humans, Male, Penis surgery, Penile Implantation, Penile Induration surgery, Penile Prosthesis
- Published
- 2021
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27. Vasectomy Reversal Online Marketing Practices: What Are We Putting Out There?
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Jimbo M, Jefferson FA 4th, Ungerer GN, Ziegelmann MJ, Köhler TS, and Helo S
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- Adult, Cities, Fees and Charges, Fellowships and Scholarships statistics & numerical data, Female, Humans, Institutional Practice statistics & numerical data, Internet, Male, Middle Aged, Practice Patterns, Physicians', Private Practice statistics & numerical data, United States, Urologists economics, Urologists education, Marketing of Health Services statistics & numerical data, Urologists standards, Urologists statistics & numerical data, Vasovasostomy economics
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Objective: To determine characteristics of providers marketing vasectomy reversal (VR) online, degree of information available online, the ease with which patients can compare providers, and the differences in VR practice patterns between academic and private practices., Materials and Methods: We identified VR practices operating within the top 50 most populous metropolitan areas in the US. Practice websites were reviewed to obtain information such as provider educational background, level of magnification, ability to perform vasoepididymostomy, surgical volume, and cost. Based on information available, providers were assigned a novel REVERSAL score created by the authors. Descriptive statistics were used to compare results., Results: Of the 107 providers identified (29 academic, 78 private), the majority were male urologists with a Doctor of Medicine degree. Academic providers were more likely to have fellowship training than private practice providers, 96.6 vs 43.6%, respectively (P = 0.00001). Compared to non-urologists, urologists were less likely to purchase online ads or disclose cost. Non-urologists charged significantly less than urologists, $3,584 ± 1,554 and $6,591 ± 1,518, respectively (P = 0.00001). Only one provider provided complete information as defined by REVERSAL score of 12, with the majority (61.7%) of providers achieving score ≤6., Conclusion: There is significant lack of transparency in publicly available information from VR practices. Practices should implement measures to improve dissemination of information to the public, so that patients can more easily compare providers and make informed decisions regarding VR., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
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28. Testicular sperm extraction vs. ejaculated sperm use for nonazoospermic male factor infertility.
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Kendall Rauchfuss LM, Kim T, Bleess JL, Ziegelmann MJ, and Shenoy CC
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- Abortion, Spontaneous etiology, Adult, Databases, Factual, Female, Humans, Live Birth, Male, Oligospermia diagnosis, Oligospermia physiopathology, Pregnancy, Pregnancy Rate, Retrospective Studies, Treatment Outcome, Ejaculation, Fertility, Oligospermia therapy, Sperm Injections, Intracytoplasmic adverse effects, Sperm Retrieval adverse effects
- Abstract
Objective: To study the potential benefit of testicular sperm compared with ejaculated sperm for men with oligospermia., Design: After exemption from institutional review board approval, we performed a retrospective cohort study using the Mayo Clinic Assisted Reproductive Technology database., Setting: Single academic center., Patient(s): Couples with nonazoospermic male factor infertility (total motile sperm <25 million per ejaculate) undergoing intracytoplasmic sperm injection with sperm obtained by testicular sperm extraction (TESE) or ejaculated sperm between 2016 and 2019., Intervention(s): In vitro fertilization, Intracytoplasmic sperm injection, TESE., Main Outcome Measure(s): The primary outcome was live birth rate. The secondary outcomes were fertilization rate, blastulation rate, pregnancy rate, and miscarriage rate., Result(s): Subjects in the two groups were similar in age, body mass index, and ovarian reserve. Baseline sperm parameters were similar in the two groups: total motile sperm (5.4 in the ejaculate sperm group vs. 3.6 million motile per ejaculate), except that baseline motility was higher in the group that used ejaculated sperm (40% vs. 29%). The total number of mature oocytes retrieved was similar in the two groups, but the use of TESE was associated with a 20% decrease in fertilization (60.0% vs. 80.6%) and half the number of blastocyst embryos (two vs. four) compared with ejaculated sperm. Compared with ejaculated sperm, use of TESE did not improve the miscarriage rate (11% vs. 9%) or the live birth rate (50.0% vs. 31.3%)., Conclusion(s): Patients with male factor infertility and oligozoospermia did not have improved ICSI outcomes with the use of TESE samples compared with ejaculated sperm., (Copyright © 2021 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2021
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29. Low-intensity shock wave therapy for the treatment of vasculogenic erectile dysfunction: a narrative review of technical considerations and treatment outcomes.
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de Oliveira PS and Ziegelmann MJ
- Abstract
Erectile dysfunction (ED) impacts a significant portion of the aging male population. Standard treatments such as oral medications, intracavernosal injections, intraurethral suppositories, vacuum erection aids, and penile prosthesis placement have stood the test of time. Recently, there has been a growing interest in the concept of regenerative medicine with the goal of restoring or renewing functional tissue. Low intensity shock wave therapy (LiSWT) is one example of a regenerative therapy. A strong body of basic science data suggests that shockwaves, when applied to local tissue, will encourage blood vessel and nerve regeneration. Clinical evidence supports the use of LiSWT to treat conditions ranging from ischemic heart disease, musculoskeletal injuries, and even chronic non-healing wounds. LiSWT is also being used to treat male sexual dysfunction conditions such as Peyronie's Disease and ED. The first studied application of LiSWT for ED was published in 2010. Since then multiple randomized, sham-controlled trials have sought to evaluate outcomes for this novel therapy in men with vasculogenic ED. Additionally, several meta-analyses are available with pooled data suggesting that LiSWT results in a significantly greater improvement in erectile function relative to sham-control. Despite these promising findings, the current body of literature is marred by significant heterogeneity relating to treatment protocols, patient populations, and follow-up duration. Further work is necessary to determine optimal device technologies, patient characteristics, and treatment duration prior to considering LiSWT as standard of care for men with ED., Competing Interests: Conflicts of Interest: The authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/tau-20-1286). The series “Controversies and Considerations of Penile Surgery” was commissioned by the editorial office without any funding or sponsorship. The authors have no other conflicts of interest to declare., (2021 Translational Andrology and Urology. All rights reserved.)
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- 2021
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30. EDITORIAL COMMENTS.
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Ziegelmann MJ
- Published
- 2021
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31. Long-term Success With Diminished Opioid Prescribing After Implementation of Standardized Postoperative Opioid Prescribing Guidelines: An Interrupted Time Series Analysis.
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Findlay BL, Britton CJ, Glasgow AE, Gettman MT, Tyson MD, Pak RW, Viers BR, Habermann EB, and Ziegelmann MJ
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Follow-Up Studies, Humans, Interrupted Time Series Analysis, Male, Middle Aged, Practice Guidelines as Topic, Prospective Studies, Young Adult, Analgesics, Opioid therapeutic use, Guideline Adherence statistics & numerical data, Pain, Postoperative drug therapy, Practice Patterns, Physicians' trends, Urologic Surgical Procedures
- Abstract
Objective: To assess longitudinal prescribing patterns for patients undergoing urologic surgery in the nearly 2-year time frame before and after implementation of an evidence-based opioid prescribing guideline to accurately characterize the impact on postoperative departmental practices., Patients and Methods: Historical prescribing data for adults who underwent 21 urologic procedures at 3 academic institutions were used to derive a 4-tiered guideline for postoperative opioid prescribing. The guideline was implemented on January 16, 2018, and prescribing patterns including quantity of opioids prescribed (in oral morphine equivalents [OMEs]) and refill rates were compared for opioid-naïve patients undergoing urologic surgery before (January 1, 2016, through January 15, 2018; N=10,649) and after (January 16, 2018, through September 30, 2019; N=9422) guideline implementation. Univariate analysis was performed using Wilcoxon rank sum and χ
2 tests. Cochran-Armitage trend tests and interrupted time series analysis were used to test for significance in the change in OMEs prescribed before vs after guideline implementation., Results: The median quantity of opioids decreased from 150 OMEs (interquartile range, 0-225) before guideline implementation to 0 OMEs (interquartile range, 0-90) after guideline implementation (P<.001). Median OMEs decreased significantly in each tier and each of 21 individual procedures. Overall guideline adherence was 90.7% (n=8547). Despite this decrease in OMEs prescribed, post-guideline implementation patients obtained fewer refills than the pre-guideline implementation group (614 [6.5%] vs 999 [9.4%]; P<.001)., Conclusion: In a multi-institutional follow-up prospective study of adult urologic surgery-specific evidence-based guidelines for postoperative prescribing, we demonstrate sustained reduction in OMEs prescribed secondary to guideline implementation and adherence by our providers., (Copyright © 2020 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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32. Collagenase clostridium histolyticum is no longer available in Europe: what does this mean for our patients with Peyronie's Disease?
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Ziegelmann MJ and Yafi FA
- Subjects
- Europe, Humans, Injections, Intralesional, Male, Penis, Treatment Outcome, Microbial Collagenase therapeutic use, Penile Induration drug therapy
- Published
- 2021
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33. Comparing and Contrasting Peyronie's Disease Guidelines: Points of Consensus and Deviation.
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Manka MG, White LA, Yafi FA, Mulhall JP, Levine LA, and Ziegelmann MJ
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- Canada, Consensus, Humans, Male, Penis surgery, Penile Implantation, Penile Induration surgery, Penile Induration therapy
- Abstract
Background: Peyronie's disease (PD) is a challenging clinical entity. To assist clinicians with diagnosis and management, four separate organizations have published PD guidelines over the past five years, but there remains a lack of consensus and data-driven recommendations for many aspects of diagnosis and treatment., Aim: To compare and contrast PD guidelines, highlighting key similarities and differences among the guideline panel recommendations and identify areas for further research., Methods: We performed an extensive review to compare and contrast diagnosis and treatment recommendations from publically available published PD guidelines from four different organizations: American Urological Association, European Association of Urology, Canadian Urologic Association, and the International Society of Sexual Medicine., Outcomes: Key similarities and differences with regards to definition, evaluation, nonsurgical and surgical treatments were compared., Results: Points of general consensus among the guideline panels included: History is adequate for diagnosis of PD, and intracavernosal injection is a gold standard to evaluate penile deformity prior to invasive intervention. Careful counseling with shared decision-making is required prior to treatment. In general, plication and incision and/or grafting surgery is reserved for patients with preserved erectile function whereas penile prosthesis implantation is the only surgical option for PD patients with erectile dysfunction. Overall, nonsurgical treatments have inferior evidence of efficacy with these being the main area of controversy; however, all societies recognize that intralesional injections may be used. 0Further research into the pathophysiology of PD may direct novel treatments targeted towards early intervention and rigorous outcomes research may direct best practices for the surgical treatment of PD in the future., Clinical Implications: PD is a challenging clinical entity. Direct comparison of the published PD guidelines highlights clear standards of care as well as areas where more research is needed to promote higher levels of evidence-based practice., Strengths & Limitations: To our knowledge this is the first report to directly compare and contrast published guidelines pertaining to the diagnosis and management of PD. Limitations include the lack of evidence-quality review pertaining to individual guideline recommendations, although this was not the aim of this review., Conclusion: We highlight consensus of major urologic societies on many aspects of work up and management of PD with notable exceptions which may guide further research. Manka MG, White LA, Yafi FA, et al. Comparing and Contrasting Peyronie's Disease Guidelines: Points of Consensus and Deviation. J Sex Med 2021;18:363-375., (Copyright © 2020 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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34. Intercourse frequency among men presenting to a sexual health clinic: does age matter?
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Westerman ME, Maldonado F, Andrews JR, Sharma V, Trost L, and Ziegelmann MJ
- Subjects
- Humans, Male, Middle Aged, Orgasm, Sexual Behavior, Sexual Partners, Coitus, Sexual Health
- Abstract
We assessed the association between intercourse frequency and sexual function among 583 consecutive males with sexual partners presenting to a men's health clinic over a 2-year period. Median age was 62 and men reported a median of 2 (IQR 0, 5) episodes of intercourse per month. Younger age, shorter relationship duration, higher intercourse satisfaction (IIEF-IS) scores, and higher libido (all p < 0.01) were associated with more frequent intercourse. On multivariable analysis, longer relationship duration was associated with less frequent intercourse (p = 0.03), but was linked to higher overall sexual satisfaction. Age was not a significant predictor of intercourse frequency.
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- 2021
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35. Long-acting liposomal bupivacaine and postoperative opioid use after Peyronie's disease surgery: a pilot study.
- Author
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Britton CJ, Findlay BL, Parikh N, Kohler T, Helo S, and Ziegelmann MJ
- Abstract
Background: Novel strategies have been proposed to minimize postoperative opioid use, yet many patients experience significant pain after penile surgery. Our objective was to evaluate postoperative opioid use in patients undergoing penile ring block with long-acting liposomal bupivacaine (LB; Exparel) during surgery for Peyronie's disease (PD)., Methods: We identified patients who underwent tunica albuginea plication (TAP) and plaque excision/grafting (PEG) for PD between July 2019 and September 2020. Intraoperatively, a ring block was administered at the penile base penis with 20 cc of LB. Patients were instructed to use over the counter pain medications as first line treatment for postoperative pain, and opioids were available for severe breakthrough pain as needed [7.5 oral morphine equivalents (OME) =5 mg oxycodone]. Opioid use was assessed during the first five days postoperatively., Results: In total, 28 patients met inclusion criteria including 18/28 (64%) who underwent TAP and 10/28 (36%) who underwent PEG. Median patient age was 56 years (IGR 51;61). Median postoperative 10-point visual analogue pain score was 0 (range 0-3). Duration of penile anesthesia ranged from 1.5-4 days. In total, 9/28 patients (32%) utilized opioids during the first five days postoperatively (range 7.5-75 OME). Two patients (7%) required opioids during the first two days after surgery. 27/28 (96%) were satisfied or highly satisfied with postoperative pain control., Conclusions: Intraoperative penile ring block with LB resulted in excellent pain control with local anesthetic duration of 1.5-4 days. The majority of patients did not require any opioids during the early postoperative period. Further study comparing outcomes with shorter-acting local anesthetics is necessary to balance pain control benefits with additional cost., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/tau-20-871). Dr. Kohler serves as an unpaid Associate Editor-in-Chief of Translational Andrology and Urology from January 2020 to December 2021. The other authors have no conflicts of interest to declare., (2021 Translational Andrology and Urology. All rights reserved.)
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- 2021
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36. Malpractice Litigation in Iatrogenic Ureteral Injury: a Legal Database Review.
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Bole R, Linder BJ, Gopalakrishna A, Kuang R, Boon AL, Habermann EB, Ziegelmann MJ, Gettman MT, Husmann DA, and Viers BR
- Subjects
- Humans, United States, Databases, Factual, Malpractice legislation & jurisprudence, Ureter injuries
- Abstract
Objective: To examine the factors associated with iatrogenic ureteral injury litigation and outcomes., Methods: The Westlaw legal database was queried for all iatrogenic ureteral injury cases. Variables extracted included available clinical factors, method of settlement, and litigation outcomes. Linear regression analysis was conducted to examine factors associated with award amount., Results: A total of 522 cases from 1961 to 2019 were included in the study. The most common specialty named was gynecology (353/512, 68.9%), followed by urology (89/512, 17.4%). The most common claim was intraoperative negligence (474/522 cases, 90.8%). Fifty two cases were settled or arbitrated and 470 went to trial. Settlement or arbitration was more likely in cases involving institution-only defendant (15.4% vs 7.3%, P< .01), academic institution (19.7% vs 7.1%, P < .01), and patient death (42.9% vs 10.7%; P < .001). Of cases that went to trial, the verdict favored the defendant in 339/470 cases (72.1%). The median award was $552,822.96 (interquartile range 187,007-1,063,603). Duration of temporary drainage ($5050/day, P = .02), delayed repair (P = .03), claim of inadequate workup (P = .03), and claim of failure to supervise trainee (P < .001) were significantly associated with increasing award amount., Conclusion: The majority of ureteral injury litigation ruled in favor of the defendant. However, when awarded, the amount was substantial and correlated with drainage duration, delayed repair, claim of inadequate workup, and failure to supervise trainee. These findings highlight factors perceived to be associated with significant distress and reflect trends in medicolegal decision-making., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
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37. Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases.
- Author
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Joseph J, Ziegelmann MJ, Alom M, Savage J, Köhler TS, and Trost L
- Subjects
- Follow-Up Studies, Humans, Male, Penis, Traction, Treatment Outcome, Penile Induration therapy
- Abstract
Background: A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie's disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial., Aim: To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854)., Methods: A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD., Outcomes: The primary outcomes are safety, penile length, penile curvature, Peyronie's Disease Questionnaire, International Index of Erectile Function, and satisfaction., Results: 6-month (n = 64) and 9-month (n = 63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7-2.0 cm) and curvature improvements (18-20%). PTT-to-PTT men also achieved additional length (0.6-0.8 cm) without further curvature improvements. An as-treated analysis of PTT use ≥15 minute/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18-21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie's Disease Questionnaire were significantly improved (except orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0-2.2 cm), and 61% had curve improvements (16.8-21.4° [32.8-35.8%]). RestoreX was preferred 3-4:1 over all other PD treatments, and 100% preferred it over other PTT devices., Clinical Implications: Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs., Strengths & Limitations: Strengths include largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3-9 hours) treatment arm., Conclusion: PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD. Joseph J, Ziegelmann M, Alom M, et al. Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases. J Sex Med 2020;17:2462-2471., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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38. Peyronie's Disease and the Female Sexual Partner: A Comparison of the Male and Female Experience.
- Author
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Farrell MR, Ziegelmann MJ, Bajic P, and Levine LA
- Subjects
- Female, Humans, Male, Middle Aged, Penis, Retrospective Studies, Sexual Behavior, Sexual Partners, Penile Induration
- Abstract
Background: Peyronie's disease (PD) is characterized by penile pain, deformity, and sexual dysfunction, often resulting in an impaired sexual experience and significant psychological bother for the patient. However, there are limited data on the impact of PD on female sexual partners (FSPs)., Aim: To compare the psychosexual experience of men with PD and their FSPs., Methods: We retrospectively reviewed all prospectively enrolled men and their FSPs who presented for initial PD evaluation to our sexual health clinic from July 2018 to February 2020. All men completed a PD-specific survey and the PD questionnaire (PDQ). If the patient was accompanied by an FSP during initial evaluation, she completed the PDQ for Female Sexual Partners and Female Sexual Function Index. We further queried our database that included information on patient demographics and clinical characteristics., Outcomes: The main outcome of this study is retrospective comparison of responses with the PDQ and PDQ for Female Sexual Partners., Results: Data were available for 44 men with PD (median age, 56 years; interquartile range, 49-63) and their FSPs (median age, 54 years; interquartile range, 50-61). The majority of men presented in the chronic phase (35 of 44, 79.5%), and median objective composite curvature was 75° (interquartile range, 50-90°). Owing to PD, female and male partners reported similar difficulty with vaginal intercourse (VI) (74.3% vs 81.5%, P = .555), decreased frequency of VI (70.6% vs 85.2%, P = .228), and at least moderate discomfort/pain with VI (48.6% vs 33.3%, P = .232). FSPs were "very" or "extremely" bothered by the appearance of their partner's erect penis less often than male partners (20.0% vs 59.3%, P < .001). FSPs were "very" or "extremely" bothered by their partner's PD during VI less often than men with PD (32.3% vs 65.2%, P = .017). Few FSPs (22.9%) had "severe" or "very severe" concern with damaging their partner's penis during VI., Clinical Implications: The sexual experience for men with PD and their FSPs differs, thus emphasizing the importance of active engagement of both men with PD and FSP during initial PD evaluation., Strengths and Limitations: This initial study draws data from a single, high-volume men's health clinic with a limited sample size. Survey responses may have been shared by patients with PD and their FSPs., Conclusion: PD impacts the sexual experience for both men and FSPs. A similarly large proportion of men with PD and FSP noted decreased frequency of and difficulty with vaginal intercourse. Yet, FSPs were less bothered by the appearance of the erect penis and the deformity during VI compared with men. Farrell MR, Ziegelmann MJ, Bajic P, et al. Peyronie's Disease and the Female Sexual Partner: A Comparison of the Male and Female Experience. J Sex Med 2020;17:2456-2461., (Copyright © 2020. Published by Elsevier Inc.)
- Published
- 2020
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39. Penile prosthesis infection-moving the needle forward: a commentary on risk factors associated with penile prosthesis infection: systematic review and meta-analysis.
- Author
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Ziegelmann MJ
- Subjects
- Humans, Male, Risk Factors, Penile Diseases surgery, Penile Implantation adverse effects, Penile Prosthesis adverse effects, Penis surgery, Prosthesis-Related Infections microbiology
- Published
- 2020
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40. A Review of Treatment-Related Outcomes in Female Partners of Men With Peyronie's Disease-An Opportunity for Improved Assessment.
- Author
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Parikh NN, Heslop DL, Bajic P, Bole R, Farrell MR, Levine LA, and Ziegelmann MJ
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- Female, Humans, Male, Treatment Outcome, Penile Induration therapy, Sexual Partners psychology, Women psychology
- Abstract
Introduction: Peyronie's disease (PD) is a disorder of the penile tunica albuginea, causing penile deformity, shortening, pain, and sexual dysfunction. While studies have shown treatment efficacy for patients, research on treatment-related outcomes for sexual partners is lacking., Objectives: We sought to review the literature on clinical characteristics and treatment-related outcomes from the perspective of female sexual partners of PD patients., Methods: We performed a comprehensive literature search of PubMed, Embase, and MEDLINE databases to identify all studies pertaining to PD and partner satisfaction through December 2019. 13 articles that discussed partner satisfaction with treatments of PD including oral, intralesional, and surgical therapy were found in the literature review., Results: At baseline, female partners of men with PD report lower sexual satisfaction and dyspareunia. Results showed that intralesional injection of collagenase Clostridium histolyticum resulted in partner satisfaction in approximately 70% of patients based on differing definitions. Penile plication demonstrated variable partner satisfaction ranging from 34% to 88% whereas plaque incision or partial excision with grafting achieved rates ranging from 90% to 100%. Penile prosthesis implantation resulted in partner satisfaction rates ranging from 40% to 75%., Conclusion: PD has a negative impact on psychological and emotional well-being for both patients and their female partners. Surgical and non-surgical treatment for PD has the ability to improve sexual satisfaction of partners. Studies discussed focus on the various forms of treatment for men with PD; however, the available studies were notably limited by small sample sizes, inconsistent use of validated questionnaires, and lack of control groups. In addition, the topic of partner satisfaction discussed in the articles mainly examined the response of female partners and did not discuss effects of the disease on male partners. Clinicians should consider carefully screening PD partners for sexual dysfunction to optimize couple-focused therapy. Further studies are needed to evaluate effects on male sexual partners of PD patients. Parikh NN, Heslop DL, Bajic P, et al. A Review of Treatment-Related Outcomes in Female Partners of Men With Peyronie's Disease-An Opportunity for Improved Assessment. J Sex Med 2020;8:548-560., (Copyright © 2020 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2020
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41. Amphetamine/Dextroamphetamine Salts for Delayed Orgasm and Anorgasmia in Men: A Pilot Study.
- Author
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Levine LA, Betcher HK, Ziegelmann MJ, and Bajic P
- Subjects
- Aged, Amphetamine adverse effects, Central Nervous System Stimulants adverse effects, Ejaculation physiology, Humans, Male, Middle Aged, Orgasm physiology, Pilot Projects, Prospective Studies, Sleep Initiation and Maintenance Disorders chemically induced, Sleep Initiation and Maintenance Disorders epidemiology, Time Factors, Amphetamine administration & dosage, Central Nervous System Stimulants administration & dosage, Orgasm drug effects
- Abstract
Objective: To describe our experience with amphetamine/dextroamphetamine salts (AMP) as a treatment for delayed orgasm/anorgasmia (DO/AO)., Methods: We identified patients with DO/AO from September 2017 to September 2019. Baseline characteristics and patient-reported orgasmic latency time (OLT) were recorded. After extensive screening, patients were treated with AMP. Validated questionnaires were administered including International Index of Erectile Function, quantitative Androgen Deficiency in the Aging Male and Adult ADHD Self-Report Scale. OLT change, adverse effects, and patient satisfaction were assessed. Baseline characteristics were compared using chi-squared test. OLT changes were compared with one-way ANOVA. Multivariable logistic regression was performed to identify predictors of treatment success. P < 0.05 was statistically significant., Results: Seventeen men received AMP - 6 of 17 (35.3%) for AO and 11 of 17 (64.7%) for DO, with median follow-up 1.0 year (interquartile range [IQR] 1.0 year). Amongst responders, AMP improved subjective experience of sex in 8 of 17 (47.1%) patients (2/6 with AO). Of those, 6 of 17 (35.3%; 1/6 with AO) experienced reduced OLT or increased frequency of orgasm. Non-responders were older than responders, with median age 69.5 (IQR 4.3) vs 61.0 years (IQR 12.3; P = 0.024). There were no other significant differences in baseline characteristics among responders. Of note, 6 of 8 (75%) responders and 8 of 9 (88.9%) non-responders failed other treatment modalities prior to AMP. Among responders with DO and improved OLT, mean OLT decreased by 72.3% (40.7 to 11.1 minutes, P = 0.049) during intercourse. Minimal side effects were noted including insomnia and jitters, each in one patient respectively., Conclusion: AMP as a treatment for AO/DO merits further investigation. Measurable improvements in OLT or frequency of orgasm occurred in more than a third of patients. Larger prospective multicenter studies with strict inclusion and exclusion criteria are warranted., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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42. Comparative Postoperative Outcomes of Rezūm Prostate Ablation in Patients with Large Versus Small Glands.
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Bole R, Gopalakrishna A, Kuang R, Alamiri J, Yang DY, Helo S, Ziegelmann MJ, and Köhler TS
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- Humans, Male, Retrospective Studies, Treatment Outcome, Hyperthermia, Induced, Prostatic Hyperplasia surgery
- Abstract
Introduction: Rezūm water vapor thermal ablation is a new minimally invasive technique used to treat benign prostatic hyperplasia. Major advantages include minimal anesthesia and recovery time, low rate of sexual side effects, and durable clinical improvement. However, data are lacking regarding use of Rezūm in prostate glands >80 cc. Here we seek to examine the clinical outcomes of men with large prostate glands following Rezūm. Patients and Methods: We retrospectively reviewed patients who underwent Rezūm therapy at our institution since July 2017. Three-month postoperative outcomes were analyzed, including American Urological Association symptom score (AUASS), peak flow, and postvoid residual (PVR). Complications, including hematuria and urinary tract infections, were also assessed. All statistical analyses were conducted using RStudio 1.2.1335. Results: One hundred eighty-two patients undergoing Rezūm were identified, of whom 25.8% had prostate volume >80 cc. Mean gland volume in this group was 119 cc and 55.3% were catheter dependent. Following Rezūm, statistically significant improvement was seen in AUASS from 22 to 13.4 ( p = 0.04) and PVR from 305 to 149 cc (0.05). Statistically significant improvement was seen in peak flow rate from 7.7 to 12.7 mL/second ( p = 0.002). In a subset of catheter-dependent patients, the postoperative catheter-free rate was 83% for men with glands >80 cc, which was comparable with 88% in the smaller gland group. Postoperative complication rate was not significantly different between large or small glands. Conclusions: In our experience, Rezūm is efficacious in patients with glands >80 cc. Patients experience symptomatic and objective improvement in voiding parameters that is comparable with patients with glands smaller than 80 cc. Among catheter-dependent patients with glands >80 cc, over 80% are catheter free after Rezūm. Our experience supports the consideration of Rezūm in patients with prostate glands >80 cc; further studies are warranted to confirm long-term outcomes.
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- 2020
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43. Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer.
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Jimbo M, Alom M, Pfeifer ZD, Haile ES, Stephens DA, Gopalakrishna A, Ziegelmann MJ, Viers BR, Trost LW, and Kohler TS
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- Humans, Male, Orgasm, Prevalence, Prostatectomy, Erectile Dysfunction, Prostatic Neoplasms epidemiology, Prostatic Neoplasms radiotherapy, Prostatic Neoplasms surgery
- Abstract
Background: Climacturia is an under-reported complication of definitive therapy for prostate cancer (PCa) - that is, radical prostatectomy (RP) and/or radiation therapy (RT)., Aim: We sought to identify the prevalence and predictors of climacturia and associated patient/partner bother in patients with and without prior PCa treatment., Methods: We analyzed a database of patients who presented to our Men's Health clinic and filled out a questionnaire related to sexual function and pertinent medical histories. The prevalence of climacturia and associated patient/partner bother in patients with/without prior RP/RT was calculated. Univariable and multivariable logistic regressions were performed to identify predictors associated with climacturia and patient/partner bother., Outcomes: The primary outcomes were the prevalence and predictors of climacturia and associated patient/partner bother in patients with/without history of definitive PCa treatment., Results: Among 1,117 patients able to achieve orgasm, 192 patients (17%) had prior history of definitive therapy for PCa (RP alone = 139 [72%]; RT alone = 22 [11%]; RP + RT = 31 [16%]). Climacturia was reported by 39%, 14%, 52%, and 2.4% of patients with history of RP alone, RT alone, RP + RT, and neither RP nor RT, respectively (P < .05 between all groups). 33 to 45 percent of patients with climacturia noted significant patient/partner bother. Factors significantly associated with climacturia were prior RP, prior RT, history of other prostate surgery, and erectile dysfunction, although erectile dysfunction was not significant on multivariable analysis. Significant reduction in climacturia prevalence was noted for patients who were ≥1 year out from RP, compared with patients who were <1 year out. Among patients with prior RP/RT, stress urinary incontinence was associated with increased risk of climacturia, whereas diabetes was associated with decreased risk. No factors were associated with patient/partner bother. Among patients with prior RP, nerve-sparing technique did not predict presence of climacturia but was associated with reduced patient/partner bother., Clinical Translation: Given significant prevalence of climacturia and associated patient/partner bother, patients should be counseled on the risk of climacturia before undergoing RP/RT., Strengths and Limitations: Strengths include the large study population and the focus on both RP and RT. Limitations include the facts that this is a single-institution study that primarily relies on patients' subjective reporting and that the study population may not represent the general population., Conclusions: Climacturia affects a significant proportion of patients with history of RP/RT for PCa, and many patients and their partners find this bothersome. Jimbo M, Alom M, Pfeifer ZD, et al. Prevalence and Predictors of Climacturia and Associated Patient/Partner Bother in Patients With History of Definitive Therapy for Prostate Cancer. J Sex Med 2020;17:1126-1132., (Copyright © 2020 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2020
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44. Peyronie's disease: Contemporary evaluation and management.
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Ziegelmann MJ, Bajic P, and Levine LA
- Subjects
- Humans, Injections, Intralesional, Male, Penis, Erectile Dysfunction, Penile Diseases, Penile Induration drug therapy, Penile Induration therapy
- Abstract
Peyronie's disease is a common yet poorly understood condition characterized by penile pain, curvature, sexual dysfunction and psychological bother. Peyronie's disease represents a penile wound healing disorder, and is thought to arise from exuberant scarring in response to penile trauma in genetically predisposed men. In the absence of active treatment, the majority of men experience stable or worsening symptoms, with few reporting spontaneous resolution in penile curvature or other deformity. In contrast, penile pain improves or resolves in the majority of men. Treatment options vary based on symptom severity and stability. Several oral therapies are commonly prescribed, although to date there are no strong data to support any oral agents as monotherapy for Peyronie's disease. Other options including penile traction therapy and intralesional injections result in modest improvements for many patients, particularly when used early after symptom onset. Penile straightening through approaches, such as penile plication and plaque incision or partial excision and grafting, represent the most rapid and reliable approach to correct penile curvature once the symptoms have stabilized. Side-effects vary based on the type of surgery carried out, and include penile shortening, sensation changes and erectile dysfunction in the minority of men. In patients with drug refractory erectile dysfunction and Peyronie's disease, placement of a penile prosthesis will address both issues, and is associated with high levels of patient satisfaction. The current review provides a practical approach to the modern evaluation and management of patients presenting with Peyronie's disease., (© 2020 The Japanese Urological Association.)
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- 2020
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45. Opioid prescribing after urologic surgery: we are part of the problem and part of the solution-an invited commentary on "an opioid prescription for men undergoing minor urologic surgery is associated with an increased risk of new persistent opioid use".
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Ziegelmann MJ, Findlay BL, Britton CJ, and Habermann EB
- Abstract
Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/tau-2020-05). MJZ reports personal fees from Paradigm Medical Communications, outside the submitted work. The other authors have no conflicts of interest to declare.
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- 2020
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46. The Influence of Indentation Deformity on Outcomes With Intralesional Collagenase Clostridium Histolyticum Monotherapy for Peyronie's Disease.
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Ziegelmann MJ, Heslop D, Houlihan M, Bajic P, Helo S, Trost L, and Kohler T
- Subjects
- Antifibrotic Agents administration & dosage, Clinical Protocols, Humans, Male, Middle Aged, Patient Acuity, Penis pathology, Penis physiopathology, Recovery of Function drug effects, Treatment Outcome, Injections, Intralesional methods, Microbial Collagenase administration & dosage, Penile Induration diagnosis, Penile Induration drug therapy, Penile Induration physiopathology
- Abstract
Objective: To identify patient-specific factors associated with patient-reported improvements in functional outcomes after intralesional Collagenase Clostridium histolyticum (CCH) for Peyronie's Disease (PD)., Methods: We retrospectively explored our prospectively maintained CCH registry. We sought to identify patient-specific factors that prevented the need for surgical straightening and/or improved ability to engage in penetrative intercourse., Results: Eighty-six patients underwent CCH monotherapy and had objective follow-up data available. Mean PD symptom duration was 25 months (SD 44) and baseline curvature was 65
o (SD 24). Prominent indentation/hourglass deformities (defined as girth discrepancy >10%) were present in 40 patients (47%). Mean objective curve improvement was 19o (SD 20), and 60% achieved improvement ≥15o . Greater baseline curvature was associated with greater absolute improvements in curvature, although there was no association between baseline curvature and relative (%) improvement. Three of 40 patients (8%) with indentation achieved girth improvement. Patients with baseline indentation/hourglass were less likely to report that CCH prevented the need for surgery (35% vs 64%, P = .018). Patients with curve improvement <15o were also less likely to report that CCH prevented the need for surgery (25% vs 63%, P = .0086) or improved penetration (54% vs 89%, P = .018). There were no differences in outcomes based on age, BMI, symptom duration, and presence of biplanar curvature., Conclusion: Baseline indentation/hourglass deformity and curve improvement <15o are associated with less favorable functional improvements such as preventing the need for surgery and improving penetration., (Copyright © 2020 Elsevier Inc. All rights reserved.)- Published
- 2020
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47. Characteristics of Men With Peyronie's Disease and Collagenase Clostridium Histolyticum Treatment Failure: Predictors of Surgical Intervention and Outcomes.
- Author
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Bajic P, Wiggins AB, Ziegelmann MJ, and Levine LA
- Subjects
- Clostridium histolyticum, Humans, Injections, Intralesional, Male, Penis diagnostic imaging, Penis surgery, Retrospective Studies, Treatment Failure, Treatment Outcome, Microbial Collagenase therapeutic use, Penile Induration drug therapy, Penile Induration surgery
- Abstract
Background: A subset of patients with Peyronie's disease (PD) treated with collagenase clostridium histolyticum (CCH) experience persistent bother and some require surgery., Aim: We characterize patients experiencing persistent bother after CCH treatment and identify associations and predictors of surgical intervention/outcomes., Methods: We retrospectively identified patients with PD from October 2014 to October 2019 and identified those presenting with persistent bother after CCH treatment by other urologists. Intracavernosal injection and penile Doppler ultrasonography were performed, and subsequent interventions/outcomes were recorded. Baseline characteristics were compared with Student t-test and chi-square test. Predictors of surgical intervention and complications were assessed using multivariable logistic regression., Outcomes: The primary outcome was surgery after CCH treatment. Secondary outcomes included worsened erectile function, sensory deficits, and penile length change., Results: Of 573, 67 (11.7%) patients with PD had undergone prior CCH treatment with median 6 injections (range 2-24). Mean post-CCH PD Questionnaire bother score was 10.1 (SD: 3.1), and total International Index of Erectile Function-5 was 15.3 (SD: 8.7). Mean PD duration was 27.8 (SD: 35.7) months, with a mean composite curvature (MCC) of 69.0° (SD: 33.8) measured after injection. Of 67, 44 (65.7%) patients had MCC >60°. Of 67, 52 (77.6%) patients had indent, narrowing, or hourglass and 26 (38.8%) had hinge effect (buckling of the erect penis with axial pressure) on examination. Calcification was identified in 26 of 67 (38.8%) patients, with grade 3 calcifications comprising 6 of 23 (26.1%) patients. Of 67, 33 (49.3%) patients underwent surgery, with 20 (60.1%) undergoing partial plaque excision and grafting with/without tunica albuginea plication, 6 (18.2%) undergoing tunica albuginea plication alone, and 7 (21.2%) undergoing penile prosthesis with plaque incision and grafting. Surgical patients had greater mean curvature (82.6 vs 55.4, P = .001) and were more likely to have hinge (54.5% vs 20.6%, P = .005). On multivariable analysis, MCC ≥60° predicted patient's decision for surgery (odds ratio: 2.99, P < .01, 95% confidence interval: 1.62-4.35). There were no associations between surgical complications and number of injections or CCH-associated adverse events., Clinical Implications: Patients presenting with persistent bother after CCH treatment often have narrowing and calcifications (despite calcifications being a contraindication to CCH treatment), and those who have hinge or severe curvature are more likely to undergo surgery with low rates of complications., Strengths/limitations: This study's generalizability is limited by selection bias, but useful data are provided for patient counseling., Conclusion: Patients with persistent bother after CCH treatment had high rates of indentation/narrowing, plaque calcifications, and MCC >60° at completion of CCH treatment. Surgical intervention is more common with hinge and is safe and feasible in these patients, with low rates of complications. These findings suggest possible negative prognostic factors for CCH treatment, which merit further investigation. Bajic P, Wiggins AB, Ziegelmann MJ, et al. Characteristics of Men With Peyronie's Disease and Collagenase Clostridium Histolyticum Treatment Failure: Predictors of Surgical Intervention and Outcomes. J Sex Med 2020;17:1005-1011., (Copyright © 2020 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2020
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48. Peyronie's Disease Intervention Studies: An Exploration of Modern-Era Challenges in Study Design and Evaluating Treatment Outcomes.
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Ziegelmann MJ, Trost LW, Russo GI, and Levine LA
- Subjects
- Humans, Male, Reproducibility of Results, Sexual Behavior, Surveys and Questionnaires, Treatment Outcome, Penile Induration physiopathology, Penis physiopathology, Research Design
- Abstract
Introduction: Peyronie's disease (PD) is characterized by pain, deformity, sexual dysfunction, and psychological bother. Several treatments are available with varying levels of efficacy, and significant limitations exist with the currently available literature., Aim: To explore modern-era methodological challenges inherent to PD research as they pertain to intervention studies., Methods: We performed a critical review of the PD intervention literature to identify common methodological challenges with emphasis on aspects of patient assessment and treatment outcomes, study design, and statistical analysis. The key objective was to provide an impetus on which to build future research protocols, rather than focus on weaknesses with any individual studies., Main Outcome Measure: Expert opinion was used to summarize limitations with commonly reported objective outcomes such as penile curvature, girth, and length along with imaging modalities and objective questionnaires. Appropriate study design and statistical analysis were also reviewed to discuss common pitfalls in the PD literature., Results: There are multiple shortcomings inherent to studying objective PD outcomes such as penile curvature, girth, and length. These include lack of standardized protocols for preintervention and postintervention assessment, interobserver and intraobserver variability, and lack of consistent definitions for what defines an objective outcome as clinically "meaningful" for patients. Similarly, imaging studies including penile ultrasound are subject to marked variation, thereby limiting their utility to measure predefined primary or secondary study outcomes including cavernosal artery hemodynamics and penile plaque size. Objective and validated questionnaires such as the Peyronie's Disease Questionnaire and International Index of Erectile Function require that patients have recently engaged in sexual activity, which is challenging for many patients as a result of penile deformity with PD. Finally, careful study design and statistical analysis (including appropriate study power) are imperative to ensure reliable results. Current shortcomings in the majority of studies contribute to the low level of evidence available for most PD interventions., Clinical Implications: Future PD intervention studies should focus on optimizing study design and statistical analysis. Furthermore, authors must incorporate standardized protocols for assessing preintervention and postintervention outcomes., Strength & Limitations: The current analysis and recommendations for future study are based on the expertise and opinion of the manuscript authors., Conclusion: Multiple areas of weakness in study design, statistical analysis, and patient outcomes assessment limit the reliability of data derived from PD intervention studies in the modern era. The global themes identified herein should serve as a basis upon which to build future research protocols. Ziegelmann MJ, Trost LW, Russo GI, et al. Peyronie's Disease Intervention Studies: An Exploration of Modern-Era Challenges in Study Design and Evaluating Treatment Outcomes. J Sex Med 2020;17:364-377., (Copyright © 2019 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2020
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49. Minimally invasive therapies for Peyronie's disease: the current state of the art.
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Farrell MR, Ziegelmann MJ, and Levine LA
- Abstract
Peyronie's disease (PD) is a relatively common condition that can result in significant penile deformity, sexual dysfunction, and psychological bother. Surgical straightening offers the highest probability of success during the stable phase of the disease. However, for men in the acute phase of PD or for those with less severe deformity who elect to avoid surgery, a variety of non-surgical treatment options are available. Oral therapies, including L-citrulline and pentoxifylline, are most useful as part of a combination regimen rather than as monotherapy. Intralesional therapy with IFN-α2b, verapamil, and collagenase clostridium histolyticum (CCH) can cause significant reduction in penile curvature, yet these results may not be clinically significant for men with more severe curvature. Further investigation into the timing of administration and optimal patient characteristics is required. Penile traction therapy offers a clinically significant improvement in penile length and curvature. However, this has traditionally required hours of daily therapy. Overall, a combination of oral, topical, injection and traction therapies may provide the most significant benefit among the non-surgical modalities for PD., Competing Interests: Conflicts of Interest: The focused issue “Contemporary Issues and Controversies in Men’s Health” was commissioned by the editorial office without any funding or sponsorship. LA Levine is a speaker for Abbvie and Endo, speaker and consultant for Boston Scientific and Coloplast and officer for Absorption Pharmaceuticals. The other authors have no conflicts of interest to declare., (2020 Translational Andrology and Urology. All rights reserved.)
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- 2020
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50. Clinical characteristics and surgical outcomes in men undergoing tunica albuginea plication for congenital penile curvature who present with worsening penile deformity.
- Author
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Ziegelmann MJ, Farrell MR, and Levine LA
- Subjects
- Adult, Disease Progression, Follow-Up Studies, Humans, Male, Middle Aged, Penile Induration diagnosis, Penis surgery, Postoperative Period, Retrospective Studies, Treatment Outcome, Patient Satisfaction, Penile Induration surgery, Penis abnormalities, Urologic Surgical Procedures, Male methods
- Abstract
Purpose: Men with congenital penile curvature (CPC) can develop new onset worsening of their lifelong curvature. We sought to evaluate clinical characteristics and postoperative outcomes after tunica albuginea plication (TAP) in patients presenting with CPC who reported new onset worsened curvature (CPC-WC), and compare these with patients reporting stable lifelong curve ("CPC-only")., Methods: A retrospective review of demographics, history/exam findings, and postoperative outcomes for patients with CPC who underwent TAP from 2012 to 2018 was performed. Patients were differentiated based on whether or not they reported new onset worsening of their penile curvature preoperatively (CPC-WC versus CPC only). Statistical analysis was performed to identify differences in clinical characteristics and postoperative outcomes after TAP., Results: 60 patients were included [CPC only (n = 39) and CPC-WC (n = 21)]. Mean curvature was 62° (SD 23). CPC-WC patients were older [median 34 years (IQR 27:52) versus 24 years (IQR 20:34); p = 0.004], and more likely to report penile shortening and psychological bother (p < 0.05). On physical examination, CPC-WCs were more likely to have a discrete palpable tunical scar and diminished penile elasticity (p ≤ 0.0002). With median follow up of 12 months, satisfactory straightening with TAP was reported in 56/60 patients (93%) including 35/39 (90%) CPC only and 21/21 (100%) CPC-WC., Conclusions: In men undergoing TAP for CPC, we found that 35% reported new onset worsening of their original curvature preoperatively. These patients were older and more likely to report penile shortening or exhibit palpable tunical scarring with decreased elasticity on examination compared to those with lifelong stable curvature. Regardless, TAP resulted in satisfactory penile straightening in the majority of patients.
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- 2020
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