8 results on '"Staskin, D."'
Search Results
2. Comparative analysis of real-world adherence and persistence patterns with vibegron, mirabegron, and anticholinergics in patients with overactive bladder: A retrospective claims study.
- Author
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Chastek B, Carrera A, Landis C, Snyder D, Abedinzadeh L, Bancroft T, Nesheim J, Kennelly M, and Staskin D
- Subjects
- Humans, Retrospective Studies, Male, Female, Middle Aged, Aged, Adult, Pyrrolidines, Thiazides therapeutic use, United States, Urological Agents therapeutic use, Pyrimidinones, Urinary Bladder, Overactive drug therapy, Urinary Bladder, Overactive diagnosis, Urinary Bladder, Overactive physiopathology, Cholinergic Antagonists therapeutic use, Medication Adherence, Acetanilides therapeutic use, Adrenergic beta-3 Receptor Agonists therapeutic use, Thiazoles therapeutic use
- Abstract
Introduction: Vibegron is a selective β
3 -adrenergic receptor agonist that was approved by the US Food and Drug Administration in December 2020 for the treatment of overactive bladder in adults. This retrospective study assessed US pharmacy claims data to evaluate the real-world adherence and persistence of vibegron compared with mirabegron and with anticholinergics., Materials and Methods: This analysis used the Optum Research Database to identify adults with ≥1 pharmacy claim for vibegron, mirabegron, or an anticholinergic from April 1, 2021, to August 31, 2022. Patients had ≥ 90 days of continuous commercial or Medicare medical and pharmacy coverage preindex and ≥ 60 days of continuous pharmacy coverage postindex. Two independent propensity-score models matched patients treated with (1) vibegron versus mirabegron and (2) vibegron versus anticholinergics on key variables such as demographics and clinical characteristics, index copay, days' supply, and time of entry into analysis (index quarter). Adherence was measured by proportion of days covered (PDC) from index to the end of follow-up and was defined as PDC ≥ 80%. Persistence was defined as days to discontinuation of index medication (first 30-day gap) or end of follow-up., Results: The matched vibegron and mirabegron cohorts included 4921 and 9842 patients, respectively, and the matched vibegron and anticholinergic cohorts included 4676 and 9352 patients, respectively. Patients receiving vibegron had greater mean PDC versus patients receiving mirabegron (0.67 vs. 0.64, respectively; p < 0.001) or anticholinergics (0.67 vs. 0.58; p < 0.001). A greater percentage of patients receiving vibegron were adherent versus those receiving mirabegron (49.0% vs. 45.1%, respectively; p < 0.001) or anticholinergics (49.1% vs. 38.5%; p < 0.001). Persistence was longer with vibegron compared with both mirabegron (median [95% CI], 171 [159-182] vs. 128 [122-137] days, respectively; p < 0.001) and anticholinergics (172 [159-183] vs. 91 [91] days; p < 0.001)., Conclusion: In this retrospective analysis of pharmacy claims data, patients receiving vibegron exhibited significantly higher adherence and demonstrated longer persistence in comparison to matched patient cohorts receiving either mirabegron or anticholinergics., (© 2024 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)- Published
- 2024
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3. Patient-reported outcomes from SYNERGY, a randomized, double-blind, multicenter study evaluating combinations of mirabegron and solifenacin compared with monotherapy and placebo in OAB patients.
- Author
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Robinson D, Kelleher C, Staskin D, Mueller ER, Falconer C, Wang J, Ridder A, Stoelzel M, Paireddy A, van Maanen R, Hakimi Z, and Herschorn S
- Subjects
- Double-Blind Method, Drug Therapy, Combination, Humans, Patient Reported Outcome Measures, Quality of Life, Treatment Outcome, Visual Analog Scale, Acetanilides therapeutic use, Solifenacin Succinate therapeutic use, Thiazoles therapeutic use, Urinary Bladder, Overactive drug therapy, Urological Agents therapeutic use
- Abstract
Aims: To evaluate patient-reported outcomes (PROs) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder (OAB) from the SYNERGY trial., Methods: Following a 4-week placebo run-in, period patients (≥18 years) with OAB were randomized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg + mirabegron 50 mg, (combination 5 + 50 mg), solifenacin 5 mg, mirabegron 25 mg, mirabegron 50 mg or placebo for 12 weeks, followed by a 2-week washout period. At each visit, PROs related to quality of life, symptom bother, and treatment satisfaction were assessed, including OAB-q Symptom Bother score, health-related quality of life (HRQOL) Total score, treatment satisfaction-visual analogue scale (TS-VAS), and patient perception of bladder condition (PPBC) questionnaires., Results: Overall, 3527 patients were randomized into the study, with 3494 receiving double-blind treatment. At end of treatment (EoT), both combination groups showed greater improvements in OAB-q Symptom Bother score compared with the monotherapy groups (nominal P < 0.001). Statistically significant improvements in HRQOL Total scores were observed in the combination groups versus monotherapy groups (P ≤ 0.002). For both combination groups, the OAB-q Symptom Bother score responder rates at EoT were statistically significantly higher versus mirabegron monotherapy (P < 0.05). The mean adjusted changes from baseline to EoT for PPBC were greater in the combination groups compared with monotherapy groups., Conclusions: PROs showed that combination therapy provided clear improvements and an additive effect for many HRQOL parameters, including OAB-q Symptom Bother score, HRQOL Total score, and PPBC., (© 2017 Wiley Periodicals, Inc.)
- Published
- 2018
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4. Defining female voiding dysfunction: ICI-RS 2011.
- Author
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Robinson D, Staskin D, Laterza RM, and Koelbl H
- Subjects
- Diagnostic Techniques, Urological standards, Female, Humans, Lower Urinary Tract Symptoms diagnosis, Lower Urinary Tract Symptoms epidemiology, Lower Urinary Tract Symptoms physiopathology, Lower Urinary Tract Symptoms therapy, Male, Predictive Value of Tests, Prevalence, Prognosis, Risk Factors, Severity of Illness Index, Sex Factors, Urinary Bladder innervation, Urinary Bladder Neck Obstruction classification, Urinary Bladder Neck Obstruction physiopathology, Urinary Incontinence classification, Urinary Incontinence physiopathology, Urination Disorders diagnosis, Urination Disorders epidemiology, Urination Disorders physiopathology, Urination Disorders therapy, Urodynamics, Lower Urinary Tract Symptoms classification, Terminology as Topic, Urinary Bladder physiopathology, Urination, Urination Disorders classification
- Abstract
Whilst symptoms of bladder outlet obstruction (BOO) and post micturition symptoms are more commonly reported in men a significant number of women may also complain of voiding dysfunction. However, despite the recent advances in the standardisation of terminology of lower urinary tract dysfunction there remains a lack of consensus regarding a precise diagnosis and definition of voiding abnormalities in women. In addition voiding symptoms may co-exist with storage symptoms as well as those associated with urinary incontinence. Consequently many patients present with a spectrum of different urinary symptoms, related to both storage and voiding, which may be multifactorial in origin or be related to one another. The purpose of this paper is to review the current literature in order to accurately define and classify female voiding dysfunction including causes and aetiology. In addition to reviewing the investigation and management of those women with voiding dysfunction recommendations are proposed for management in clinical practice as well as suggestions for future research., (Copyright © 2012 Wiley Periodicals, Inc.)
- Published
- 2012
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5. Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder.
- Author
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Staskin D, Khullar V, Michel MC, Morrow JD, Sun F, Guan Z, and Dmochowski R
- Subjects
- Adult, Aged, Aged, 80 and over, Analysis of Variance, Benzhydryl Compounds adverse effects, Double-Blind Method, Female, Humans, Logistic Models, Male, Middle Aged, Muscarinic Antagonists adverse effects, Placebos, Time Factors, Treatment Outcome, Urinary Bladder physiopathology, Urinary Bladder, Overactive diagnosis, Urinary Bladder, Overactive physiopathology, Urinary Incontinence diagnosis, Urinary Incontinence physiopathology, Urination drug effects, Urodynamics drug effects, Young Adult, Benzhydryl Compounds administration & dosage, Muscarinic Antagonists therapeutic use, Urinary Bladder drug effects, Urinary Bladder, Overactive drug therapy, Urinary Incontinence drug therapy
- Abstract
Aims: To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study., Methods: Subjects were randomized to fesoterodine 4 mg or placebo. At week 2, subjects could remain on 4 mg (non-escalators) or choose to increase to 8 mg (escalators) for the remaining 10 weeks (sham escalation for placebo). Subjects completed 3-day bladder diaries at baseline, week 2 and week 12 noting micturitions, urgency episodes, and urgency urinary incontinence (UUI) episodes., Results: Sixty-three per cent of 438 subjects randomized to fesoterodine and 73% of 445 randomized to placebo dose escalated. At baseline, fesoterodine escalators had significantly more micturitions and urgency episodes than fesoterodine non-escalators (P < 0.001); at week 2, before dose escalation, diary-dry rate and improvement in micturitions and urgency episodes were significantly greater among fesoterodine non-escalators versus escalators (P < 0.001); and by week 12, after dose escalation, diary-dry rate and improvements in micturitions and UUI episodes were similar between fesoterodine non-escalators and escalators (P > 0.05). The placebo escalator group did not demonstrate a similar response over placebo non-escalators following the dose escalation decision point., Conclusion: A rapid and robust response to fesoterodine 4 mg was demonstrated in non-escalators. Subjects who chose to dose escalate to fesoterodine 8 mg at week 2 showed significant improvement by week 12 versus baseline and week 2 (prior to escalation), as well as versus placebo. Dose escalation to 8 mg fesoterodine provided subjects with efficacy and tolerability similar to those who were satisfied with the 4-mg dose., (Copyright © 2011 Wiley Periodicals, Inc.)
- Published
- 2011
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6. Mechanisms of continence and surgical cure in female and male SUI: surgical research initiatives.
- Author
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Staskin D, Tubaro A, Norton PA, and Ashton-Miller JA
- Subjects
- Animals, Biomedical Research, Female, Humans, Male, Sex Factors, Treatment Outcome, Urinary Bladder innervation, Urinary Bladder physiopathology, Urinary Incontinence, Stress diagnosis, Urinary Incontinence, Stress epidemiology, Urinary Incontinence, Stress physiopathology, Urinary Bladder surgery, Urinary Incontinence, Stress surgery, Urologic Surgical Procedures
- Abstract
Aims: To report the conclusions of the Think Tank on mechanisms of incontinence and surgical cure in female and male SUI: surgical research initiatives during the ICI-RS meeting in 2010., Methods: The sub-group considered five areas for future research in stress urinary incontinence (SUI); (i) epidemiology and public health efforts in SUI, (ii) the basic sciences examining the physiology and pathophysiology of the continence mechanism, (iii) diagnostic techniques and clinical assessment of SUI, (iv) the future of treatment and surgical cure, and (v) the separate issue of male SUI., Results: Roadblocks to progress were identified for each of the five directions., Conclusions: Future research directions are suggested for each of these areas., (Copyright © 2011 Wiley-Liss, Inc.)
- Published
- 2011
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7. Female pelvic surgical devices and techniques need better evidence-based medicine.
- Author
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Staskin D and Khullar V
- Subjects
- Evidence-Based Medicine, Female, Gynecologic Surgical Procedures instrumentation, Humans, Surgical Instruments, Urologic Surgical Procedures instrumentation, Gynecologic Surgical Procedures methods, Pelvic Floor surgery, Urinary Incontinence surgery, Urologic Surgical Procedures methods, Uterine Prolapse surgery
- Abstract
The adoption of evidence-based medicine (EBM) recommendations in female pelvic surgical technique and surgical device intervention is contingent upon the availability of EBM and the willingness and ability of practitioners to accept and implement the recommendations. It can be assumed that there is virtually no disagreement among either the practitioners or the experts who practice the craft with regard to the benefits of applying scientific and clinical data that can be obtained from prior and ongoing experience to the selection of current treatments. However, there is significant controversy regarding the existence of adequate "evidence" and the mechanism for developing and applying the recommendations that can be distilled from the available data., ((c) 2010 Wiley-Liss, Inc.)
- Published
- 2010
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8. Cues to action: pelvic floor muscle exercise compliance in women with stress urinary incontinence.
- Author
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Gallo ML and Staskin DR
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Middle Aged, Surveys and Questionnaires, Cues, Exercise Therapy, Muscles physiopathology, Patient Compliance, Pelvis, Tape Recording, Urinary Incontinence, Stress therapy
- Abstract
Pelvic floor muscle exercises are recommended as an initial treatment to women with stress urinary incontinence. This treatment is often unsuccessful because of patient noncompliance. A post-test, experimental control group design was used to examine Pender's (1992) concept of an external cue to action, an audiocassette tape, to enhance patient compliance to pelvic floor exercises. Eighty-six women with urodynamically evaluated stress urinary incontinence participated through a Pelvic Floor Exercise Unit at a large teaching hospital. Patients received biofeedback training and written information to reinforce pelvic floor muscle exercises during a 45-min appointment with a nurse. Patients were instructed to perform the exercises for 10 min twice daily. Forty-three women randomly assigned to an experimental group received an audiocassette tape. Four to 6 weeks later all patients completed a researcher-developed questionnaire that was validity and reliability tested assessing pelvic floor exercise compliance. The 43 patients (100%) who received the audiocassette tape reported compliance with "routine" exercises. Twenty-two of 34 patients (65%) who did not receive the tape were compliant (P = 0.0003). Thirty-four of 41 patients (83%) who received the tape reported exercise compliance twice a day, while 4 of 34 patients (12%) in the control group were similarly compliant (P = 0.0000). The findings suggest adding an audiocassette tape to a pelvic floor exercise program enhances patient compliance for incontinent women compared to verbal and written instruction combined with biofeedback.
- Published
- 1997
- Full Text
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