Search

Aims: This study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI)., Methods: Adult females were randomized 2:1 to iltamiocel (150 × 10 6  cells) or placebo and stratified by severity and prior SUI surgery. The primary objective was efficacy based on the frequency of stress incontinence episodes (SIE) recorded in a 3-day diary at 12 months posttreatment. After 12 months, placebo participants could elect to receive open-label iltamiocel. Efficacy and safety analyses were performed using all patients as treated populations., Results: The study enrolled 311 patients, 297 were randomized to either iltamiocel (n = 199) or placebo (n = 98). Of the 295 participants that completed 12 months blinded follow-up, the proportion achieving the primary endpoint of ≥ 50% SIE reduction was not statistically different between treatment groups (52% vs. 53.6%; p = 0.798). A significantly greater proportion of iltamiocel participants in the prior SUI surgery stratum group achieved ≥ 75% SIE reduction compared with placebo, (40% vs. 16%; p = 0.037). Treatment response was maintained at 24 months in 78.4% and 64.9% of iltamiocel participants who achieved ≥ 50% and ≥ 75% SIE reduction, respectively, at Month 12. Adverse events related to the treatment were reported in 19 (9.5%) iltamiocel participants and 6 (6.1%) placebo participants., Conclusion: The study did not meet its primary endpoint however, iltamiocel cell therapy is safe and may be ideally suited to female patients who have undergone prior surgery for SUI. Additional study in this group of patients with high unmet medical needs is warranted., Trial Registration: ClinicalTrials.gov identifier: NCT01893138; EudraCT number: 2014-002919-41., (© 2024 The Author(s). Neurourology and Urodynamics published by Wiley Periodicals LLC.)

Purpose: SARS-CoV-2 infection can result in genitourinary symptoms, such as frequency, urgency, nocturia, and pain/pressure. In this study, we followed the progression of overactive bladder (OAB) symptoms in patients that reported new or worsening OAB symptoms after coronavirus disease-19 (COVID-19) diagnosis., Materials and Methods: Individuals from a COVID-19 serology study were invited to participate in a follow-up study. Respondents were divided into three groups based on prior COVID-19 testing. Patients scored symptoms retrospectively before the pandemic, at study onset, and prospectively during 12-month follow-up. Genitourinary symptoms were assessed using international consultation on incontinence questionaire for OAB (ICIQ-OAB). Change in ICIQ-OAB scores from baseline were calculated. The minimal important difference of one on ICIQ-OAB is considered a significant change., Results: 26.0% of participants previously had positive COVID polymerase chain reaction (PCR) test (PCR+), 5.6% a positive serology test only (Ser+), and 65.5% were COVID naïve (COVID-). 23.8% of participants reported a significant increase in ICIQ-OAB score at study onset compared to prepandemic. ICIQ-OAB scores were similar at prepandemic but significantly higher at study start (p < 0.001) in PCR+ group. During follow-up, change in ICIQ-OAB scores from baseline remained unchanged for COVID- group, but gradually reduced for PCR+, reaching similar levels as COVID- group by 12 months. By 12 months, 71.4% of PCR+, 42.9% of Ser+, and 68.8% of COVID- participants still reported significant increase in ICIQ-OAB scores., Conclusions: Most COVID-19 patients experienced return of symptoms to baseline, indicative of the potential resolution of COVID-associated cystitis. A subset of cases did not, raising questions about the underlying factors contributing to this outcome. Additional research is needed to assess long COVID on urological health., (© 2024 Wiley Periodicals LLC.)

Objectives: Tibial nerve stimulation is an effective treatment for overactive bladder (OAB) and has been utilized as an in-person recurring session treatment option for many years. The primary objective of this study was to evaluate the safety and efficacy of a long-term implantable device and the method of utilizing a retrograde approach to place the device (a percutaneous implantable pulse generator [pIPG] with integrated quadripolar electrodes) at the tibial nerve (Protect PNS; Uro Medical Corp.)., Methods: A novel retrograde implant technique was developed through multiple cadaveric dissections to percutaneously implant a chronic, wireless, minimally invasive pIPG device with integrated quadripolar electrodes (now licensed to Uro Medical) at the tibial nerve. A proof-of-concept pIPG device approved as part of an FDA IDE was designed to gain early experience in subjects with refractory OAB. The pIPG was implanted in the office under local anesthesia using the novel retrograde approach, and stimulation was activated using an external wireless energy source called a transmitter. Initially, a pilot study was designed to compare outcomes in subjects randomized to either percutaneous tibial nerve stimulation (PTNS) or Protect PNS. However, due to the small sample sizes available at this time, it was not possible to compare the two groups. Thus, the purpose of this manuscript is to describe the outcome of subjects who underwent implantation of the Protect PNS system. Twelve-month safety and efficacy were evaluated., Results: Nine subjects were enrolled in the randomized pilot study; 5 to the pIPG group and 4 to PTNS, and all completed the 13-week primary endpoint. Subsequently, two subjects in the PTNS group chose to cross over and have the pIPG implanted after 13 weeks. Outcomes of the seven subjects who underwent implantation of the pIPG are described. No complications related to the office procedure were noted. Two of the older model pIPG devices became nonresponsive at 1 and 4 weeks and were replaced. Six minor adverse events were reported and resolved. Subjects reported improvement in urge urinary incontinence (UUI) episodes, OAB symptoms, and quality of life. Subjects impanted with a pIPG reported a 50% reduction in UUI as early as 1 week., Conclusions: Results of this pilot study suggest that retrograde percutaneous implantation of a pIPG is a safe, minimally invasive one-stage office procedure for treatment for urge incontinence related OAB symptoms, without significant complications after 12 months follow-up. Future studies will be required to compare outcomes among treatment modalities., (© 2022 Wiley Periodicals LLC.)

Aims: Two phase 2 studies were conducted to assess the efficacy and safety of lidocaine-releasing intravesical system (LiRIS) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) with (Study 001; NCT02395042) or without, (Study 002; NCT02411110) Hunner lesions (HL)., Methods: Both were multicenter, randomized, double-blind, placebo-controlled, and enrolled women aged ≥18 years. In Study 001, patients were randomized 2:1:1 to LiRIS 400 mg/LiRIS 400 mg, placebo/LiRIS 400 mg, or placebo/placebo for a continuous 28 (2 × 14)-day period. In Study 002, patients were randomized 1:1 to LiRIS 400 mg or placebo for a continuous (single treatment) 14-day period., Results: In total, 59 and 131 patients received treatment in Studies 001 and 002, respectively. There was no statistically significant difference in the primary endpoint, the change from baseline to Week 4 of follow-up post-removal in mean daily average bladder numeric rating scale (NRS) pain score in either study (Study 001: placebo/placebo, -1.6; LiRIS/LiRIS, -2.7, p = 0.142; placebo/LiRIS, -2.5, p = 0.319; Study 002: LiRIS -1.2; placebo, -1.5, p = 0.505). There was no statistically significant difference between groups in daily worst NRS pain score, number of micturitions/day or urgency episodes/day. There was no clear trend for reduction in number of HL for LiRIS vs placebo. The frequency of treatment-emergent adverse events was similar between treatment groups in both studies; most were mild or moderate intensity., Conclusion: These studies did not demonstrate a treatment effect of LiRIS 400 mg compared with placebo, either in patients with IC/BPS with HL, or in those without HL., (© 2021 Wiley Periodicals LLC.)

Aims: In patients with pudendal neuralgia, prior studies have shown efficacy in chronic stimulation with Interstim® (Medtronic, Inc.). This feasibility study reports on the initial experience of using a wireless system to power an implanted lead at the pudendal nerve, StimWave®, to treat pudendal neuralgia., Methods: Retrospective chart review identified patients with a lead placed at the pudendal nerve for neuralgia and powered wirelessly. Clinical outcomes were assessed at Postoperative visits and phone calls. Administered non-validated follow-up questionnaire evaluated the Global Response Assessment, percentage of pain improvement, satisfaction with device, and initial and current settings of the device (h/day of stimulation)., Results: Thirteen patients had the StimWave® lead placed at the pudendal nerve, 12 (92%) female and 1 (7.6%) male. Mean age was 50 years (range: 20-58). Failed prior therapies include medical therapy (100%), pelvic floor physical therapy (92%), pudendal nerve blocks (85%), pelvic floor muscle trigger point injections (69%), neuromodulation (30.7%), or surgeries for urogenital pain (23.1%). After the trial period, 10/13 (76.9%) had >50% improvement in pain with 6/13 (46.1%) reporting 100% pain improvement. Nine underwent permanent lead placement. At last postoperative visit (range, 6-83 days), 5/9 patients reported >50% pain improvement. Seven patients reached for phone calls (22-759 days) reported symptoms to be "markedly improved" (n = 2), "moderately improved" (n = 4), or "slightly improved" (n = 1). At follow up, complications included lead migration (n = 2), broken wire (n = 1), or nonfunctioning antenna (n = 2)., Conclusion: Complex patients with pudendal neuralgia may benefit from pudendal nerve stimulation via StimWave®., (© 2021 Wiley Periodicals LLC.)

Aims: To examine the relationship between coexisting depressive symptoms and outcomes after staged neuromodulation procedures for refractory urological symptoms., Methods: Adults who enrolled in a prospective database and completed a Personal Health Questionnaire Depression Scale (PHQ-8) at baseline were reviewed. The PHQ-8 and Generalized Anxiety Disorder (GAD-7) assessed depressive/anxiety symptoms pre and 6 months post device implant. Urological symptoms were assessed with The Interstitial Cystitis Symptom Index/Problem Index (ICSI-PI) and Overactive Bladder Questionnaire (OAB-q) at baseline, 3 and 6 months, and Global Response Assessments (GRA) post implant. Subjects, grouped by PHQ <10 and PHQ ≥10, were compared with Pearson's Chi-square, Fisher's Exact or Wilcoxon rank test, and Spearman's correlations., Results: In 117 PHQ <10 and 84 PHQ ≥10 patients, age differed (mean 59 vs 52 years; P = 0.001), and PHQ <10 had lower GAD-7, ICSI-PI, and OAB-q scores at baseline (P < 0.0001, P = 0.0003, and P < 0.0008, respectively). Implantation rates were similar between groups. Reoperation and complication rates within the first 6 months did not differ, similar proportions (majority) were improved on the GRA at each time point, and ICSI-PI and OAB-q scores improved significantly. PHQ scores only improved significantly for those with baseline PHQ ≥10. Baseline PHQ strongly correlated with GAD-7 at baseline and 6 months, and baseline ICSI-PI. Change in PHQ positively correlated with the change in GAD-7, 6 month ICSI-PI, and change in ICSI-PI from baseline to 6 months., Conclusions: Coexisting depressive symptoms do not limit the efficacy of neuromodulation and PHQ improvements correlate with improved anxiety and bladder symptoms., (© 2017 Wiley Periodicals, Inc.)

Aims: To evaluate neuromodulation outcomes in patients with prior back surgery., Methods: Adults in our prospective observational sacral/pudendal neuromodulation study were retrospectively evaluated. History and operative details were reviewed, and outcomes were measured at 3, 6, 12, and 24 months with overactive bladder questionnaire (OAB q) symptom severity (SS)/health related quality of life (HRQOL), interstitial cystitis symptom/problem indices (ICSI - PI), voiding diaries, and global response assessments (GRA). Data were examined with Pearson's χ 2 , Fisher's exact, Wilcoxon rank sum tests, and logistic regression multivariate analysis., Results: Five hundred and sixty patients were evaluated (mean age 58.8 ± 17 years; 83% female; 79% had a sacral lead placed), 109 (19%) had history of back surgery; 66 surgeries were lumbar. Back surgery patients were older (mean 63 ± 15 vs. 58 ± 17 years; P = 0.003) and a higher proportion had urge urinary incontinence (UUI) (64% vs. 50% P = 0.008). Generator implant rates were similar (94% vs. 91%; P = 0.34). OABq-SS and HRQOL and ICSI - PI composite scores did not differ between groups at any time point. On bladder diaries, median incontinence episodes daily at baseline and between stages were worse in the prior back surgery group but all bladder diary parameters improved significantly in both groups with the exception of mean voided volume which only improved significantly in the non-back surgery group. Most patients in both groups reported moderate/marked improvement in overall bladder symptoms., Conclusions: This study suggests that prior back surgery does not appear to impact clinical outcomes; therefore, neuromodulation may be offered in this patient population., (© 2016 Wiley Periodicals, Inc.)

Aims: To explore factors that may predispose patients to reoperation after sacral neuromodulation (SNM)., Methods: Patients enrolled in our longitudinal neuromodulation database were reviewed. Medical records data, and voiding diaries, Interstitial Cystitis Symptom-Problem Indices (ICSI-PI), and Overactive Bladder Questionnaires (OAB-q) at baseline and 3 months were analyzed with Pearson's χ 2 , Fisher's Exact test, Wilcoxon rank tests, and multivariable logistic regression., Results: Of 407 patients, 134 (33%) had at least one reoperation over median 28.9 months follow-up (range 1.6-121.7); 78/407 (19%) were revised, and 56/407 (14%) were explanted. The most common reason for reoperation was lack of efficacy/worsening symptoms (n = 87). The reoperations group had a higher proportion of women (P = 0.049), lower mean body mass index (BMI; P = 0.010), more reprogramming events (P < 0.0001), longer median follow-up (P = 0.0008), and higher proportions with interstitial cystitis (P = 0.013), using hormone replacement therapy (P = 0.0004), and complications (P < 0.0001). Both reoperations/no reoperations groups had similar improvements in ICSI-PI (P < 0.0001 for both), OAB-q severity (P < 0.0001 for both) and quality of life (P < 0.0001 for both). On multivariate analysis, only longer follow-up (P = 0.0011; OR 1.048; CI 1.019, 1.078) and having a complication (P < 0.0001; OR 23.2; CI 11.47, 46.75) were significant predictors of reoperations. In women only, using HRT at time of implant was also predictive of reoperation (P = 0.0027; OR 3.09; CI 1.48, 6.46)., Conclusions: In this largest known series to date, one third of the patients required reoperation and the most common reason was lack of efficacy/worsening symptoms. Ongoing study is needed as the technology continues to evolve. Neurourol. Urodynam. 36:354-359, 2017. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Objectives: To determine: (1) if obtaining motor response on <4 tined lead electrodes at time of placement affects subjective and objective clinical outcome and (2) voltage requirements to elicit motor response at implant and first postoperative visit number based on number of responding electrodes., Methods: We reviewed our prospective neuromodulation database to identify patients with unilateral S3 lead placement and motor response (bellows ± toe flexion) on stimulation of 1-4 electrodes, then grouped by number of active electrodes at lead placement. Stage 1 success, reoperation and reprogramming rates, mean voltage at implant and first postoperative visit, and Interstitial Cystitis Symptom/Problem Indices (ICSI-PI) were analyzed using Pearson's Chi-square, Fisher's exact, Kruskal-Wallis or Wilcoxon rank tests., Results: Two hundred forty four patients met inclusion criteria, categorized into 1-2 (n = 25), 3 (n = 48), and 4 active electrodes (n = 171). There were no significant differences between groups in terms of age, indications for neuromodulation, or stage 1 success. At implant, patients with <4 active electrodes required higher mean voltages for motor responses (5.9, 4.9, and 3.9 volts for each group respectively; P < 0.0001). Mean voltages for sensory threshold at first postoperative programming were 1.5 ± 1.5, 0.9 ± 1.0, and 0.8 ± 1.0, respectively (P = 0.08). Overall reoperation rates, and reprogramming sessions at 24 months did not differ (P = 0.72 and P = 0.50). ICSI-PI scores improved similarly in all groups., Conclusions: Motor response on four electrodes is not necessary for successful stage 1 trial. Despite higher voltage requirements in those with <4 active electrodes at implant, this difference was not observed at initial postoperative programming. Neurourol. Urodynam. 35:625-629, 2016. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Aims: We evaluated whether patients stratified by age have the same level of risks/benefits after a staged neuromodulation procedure for refractory voiding symptoms., Methods: Urologic diagnosis, complications, and revisions were collected from medical records of adults enrolled in our prospective observational study. Symptoms were assessed over 2 years with diaries, Interstitial Symptom-Problem Indices (ICSI-PI), and the Overactive Bladder Questionnaire-SF (OAB-q SF). 12-item Short-Form Health Survey (SF-12v2®) mental (MCS) and physical (PCS) component summaries evaluated quality of life. Data were examined with Pearson Chi-square or Fisher's Exact test, Kruskal-Wallis tests, and repeated measures analyses., Results: Patients (83% female) were grouped by age (years): <40 (n = 46), 40-64 (n = 146), and ≥65 (n = 136). Urge incontinence was predominant in the older groups and more patients <40 had interstitial cystitis/painful bladder syndrome (IC/PBS). In the <40, 40-64, and ≥65 groups, respectively, generator implant (91%, 88%, and 89%) and explant (15%, 12%, and 10%) rates were similar. Complications (24%, 14%, and 9%; P = 0.031) and revisions (20%, 5%, and 6%; P = 0.0025) differed. For the three respective groups, urinary frequency (P < 0.0001 for all), nocturia (P < 0.0001 for all), incontinence episodes (P < 0.0001 for all), urgency (P = 0.0474, P < 0.0001, P = 0.0020), ICSI-PI (P = 0.0015, P < 0.0001, P < 0.0001), and OAB-q scores improved over time. Incontinence severity improved in those >65 (P = 0.0015). SF-12 PCS improved in those 40-64 (P = 0.0482) and MCS scores improved in the <40 and 40-64 age groups (P = 0.013 and P = 0.0440, respectively)., Conclusions: These data suggest that neuromodulation success is not age dependent, however continued study is needed to confirm findings., (Copyright © 2012 Wiley Periodicals, Inc.)

Aims: To evaluate the safety, sustained effectiveness, and treatment interval for percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB) therapy through 24 months., Methods: A prospective study following treatment success after 12 weekly PTNS treatments, subjects were prescribed a 14-week tapering protocol, followed by ongoing therapy with a Personal Treatment Plan determined by the investigator and subject to sustain subject OAB symptom improvement. Questionnaires were completed every 3 months, voiding diaries every 6 months; adverse events were reported throughout., Results: Of 50 subjects enrolled, 35 remained in the study at 24 months. During the 24 months following initial treatment success and a 14-week tapering protocol, mean treatments per month was 1.3. Voiding diary and OAB-q data demonstrate sustained improvement reported at 13 weeks through 24 months. Improvements in frequency, urge incontinence episodes, night-time voids and moderate-to-severe urgency episodes from voiding diaries at 6, 12, 18, and 24 months were statistically significant compared to baseline (prior to initial 12 weekly treatments). Compared to baseline, OAB-q symptom severity scores and health related quality of life scores were statistically significant for improvement at each tested time point. Five mild adverse events of unknown relation to treatment were reported., Conclusion: Sustained safety and efficacy of PTNS were demonstrated over 24 months with initial success after 12 weekly treatments, followed by a 14-week prescribed tapering protocol and a Personalized Treatment Plan. With an average of 1.3 treatments per month, PTNS therapy is a safe, durable, and valuable long-term OAB treatment option to sustain clinically significant OAB symptom control., (Copyright © 2012 Wiley Periodicals, Inc.)

Aims: Motor and sensory responses help guide lead placement during staged neuromodulation procedures. However, eliciting sensory responses requires lighter anesthesia. We evaluated the impact of assessing sensory responses during quadripolar tined lead placement on outcomes in subjects with refractory voiding symptoms., Methods: Adults who had a sacral lead placed were identified from our prospective neuromodulation database and grouped by whether they had intraoperative sensory testing or not. History, operative data, and implantable permanent generator (IPG) implant, lead revision and device explant rates were collected from medical records. Symptoms were evaluated with the Interstitial Cystitis Symptom Index/Problem Index (ICSI-PI) and scaled global response assessments (GRA) for the first 24 months post IPG placement. Data were analyzed using Pearson's Chi-square, Fisher's Exact, or Wilcoxon rank test., Results: Of 141 subjects (82% female), 86 (61%) had sensory testing and 55 (39%) did not. Sensory and no sensory testing groups were not significantly different on demographics, urologic diagnosis, IPG implant rates (76/84; 90% and 48/55; 87% respectively) or mean operative time (37.9 ± 13.9 minutes vs. 35.5 ± 11.6). Within 4 years, 19/141 (13.5%) were revised and/or explanted. For explant alone, 11/86 (13%) in the sensory and only 3/55 (5.5%) in the no sensory group (P = 0.16) were explanted. Overall, ICSI-PI scores improved over time (P < 0.0001) and most reported improvement on the GRA at each time point, but no differences were seen between groups., Conclusions: Intraoperative sensory testing during sacral lead placement does not necessarily improve IPG implantation rates or clinical outcomes of neuromodulation., (Copyright © 2011 Wiley Periodicals, Inc.)

Aims: Expanded indications for neuromodulation are continually being explored. We evaluated secondary changes in bowel function after successful neuromodulation for voiding symptoms., Methods: Patients in our prospective neuromodulation database study with comorbid irritable bowel syndrome (IBS), constipation and/or diarrhea, or fecal incontinence (FI) at baseline were evaluated. Pre- and 3, 6, and 12 months post-operative measures included Interstitial Cystitis Symptom Index and Problem Index (ICSI-PI), bowel diaries (assessing bowel movement frequency; constipation, diarrhea, and FI episodes), and scaled global response assessments (GRA) ("markedly worse" to "markedly improved" bowel function)., Results: Most patients reporting secondary bowel problems (128/199; 64.3%) were female (89%; mean age 56 ± 15.4 years). Primary voiding complaints were urgency/frequency (U/F) with or without urinary incontinence (n=74), interstitial cystitis/painful bladder syndrome (IC/PBS; n=43), and urinary retention (n=11). Secondary bowel complaints included constipation and/or diarrhea (49%), IBS (27%), and FI (23%). Urinary (ICSI-PI) scores improved after treatment (P<0.0001 for IBS and constipation/diarrhea; P=0.0021 for FI). Bowel diary data only indicated that mean FI episodes/day increased over time (P = 0.0100) in the FI group. Only the 12-month value (1.4 ± 2.2; n=8) was significantly different from baseline (0.3 ± 0.5; n = 18). On the GRA, only the IBS group consistently reported bowel function improvement versus worsening at each time point. Many reported no change., Conclusions: Studies have indicated that neuromodulation improves FI in carefully selected patients. The impact on other bowel conditions, including IBS, is unclear. Since voiding and bowel symptoms often coexist, it is crucial to fully evaluate all potential treatment benefits., (Copyright © 2010 Wiley-Liss, Inc.)

Aims: Chronic pudendal nerve stimulation (CPNS) is a logical alternative particularly in those who fail sacral stimulation. We evaluated symptoms, complications, and satisfaction after CPNS., Methods: We retrospectively reviewed patients having a tined lead placed at the pudendal nerve via the ischial-rectal approach. Demographics, history, complications, and pre-implant voiding diary data were collected. In those responding to CPNS, post-implant symptom changes were measured with the Interstitial Cystitis Symptom and Problem indices (ICSI-PI) and voiding diaries at 3, 6, and 12 months, and a mailed survey., Results: The majority of 84 patients (78.6% female; age 51.8 ± 16.9 years) had interstitial cystitis/painful bladder syndrome, or overactive bladder. Pudendal response (≥ 50% improvement) occurred in 60/84 (71.4%), however 5 of these chose sacral neuromodulation. Almost all (93.2%) who had previously failed sacral neuromodulation responded to pudendal stimulation. Outcomes were evaluated in 55 continuing on CPNS (median follow up 24.1 months). Seven complications requiring 5 revisions, and 4 other re-operations occurred. Five were explanted. Over time, significant improvements in frequency (P < 0.0001), voided volume (P < 0.0001), incontinence (P < 0.0001), and urgency (P = 0.0019) occurred. ICSI-PI scores significantly improved over 12 months (P < 0.0001). Survey responses indicated that most still had a device (35/40; 87.5%) continuously in use (24/29; 82.8%), and overall bladder, pelvic pain, incontinence, urgency, and frequency symptoms had improved., Conclusions: CPNS is a reasonable alternative in complex patients refractory to other therapies including sacral neuromodulation. Continued research is needed to fully assess long-term outcomes and identify predictors of success., (© 2009 Wiley-Liss, Inc.)

Aims: Global response assessment (GRA) has been used to evaluate patients' perceptions of treatment effectiveness. However, few studies have scrutinized the relationship between GRAs and objective voiding diary outcomes data. This study explores the relationship between self-reported symptom-specific GRA responses and objective changes in frequency, urgency and pelvic pain in patients with urgency-frequency with or without pelvic pain after implantation of a prosthetic sacral nerve stimulation device., Methods: Patients scheduled for a staged procedure were enrolled in a prospective, observational, longitudinal study. Post implantation, patietns were grouped into "responders" or "non-responders" based on their answers to symptom-specific GRAs at three and six months. Treatment responders were defined as those reporting "moderately" or "markedly improved" on a 7-point scale, and all others were considered non-responders. Pre- and post-implant changes in mean 24-hour voiding frequency, voided volume, urgency and pelvic pain scores as recorded on voiding diaries were compared between groups using paired t-test., Results: At three months, responders demonstrated corresponding statistically significant improvement in voiding frequency (P < 0.001), average voided volume (P = 0.003), urgency (P = 0.022) and pelvic pain (P = 0.039). At six months, responders demonstrated statistically significant improvements in frequency (P = 0.025) and urgency (P = 0.006). None of the symptom changes were statistically significant in treatment non-responders., Conclusions: The GRA non-responders groups' perceptions of treatment response agreed with their objective changes in bothersome symptoms and responders' changes agreed with their perception of improvement in the majority of symptoms. Further study is needed to standardize the GRA, and explore its potential for use in clinical practice., ((c) 2008 Wiley-Liss, Inc.)

Aims: The objective of the study was to compare sacral nerve stimulation (SNS) to pudendal nerve stimulation (PNS) for voiding dysfunction., Methods: Thirty subjects with voiding dysfunction had a tined lead placed at S3 and a second electrode implanted at the pudendal nerve via a posterior approach. In a blinded, randomized fashion, each lead was tested for 7 days. Voiding diaries and questionnaires were completed and outcomes monitored., Results: The time to place a sacral lead was 25.85 min, pudendal lead 23.71 min (P = 0.57). Twenty-four of 30 (80%) subjects responded and had a permanent implant placed. PNS was chosen as a superior lead in 79.2%, SNS was superior in 20.8%. The order in which the lead was simulated had no impact on the final lead implanted and no carry over effect was seen. Overall reduction in symptoms was 63% for PNS and 46% for SNS (P = 0.02). On a 7-point scale from markedly worse to markedly better, the pudendal lead was superior to sacral for pelvic pain (P = 0.024), urgency (P = 0.005), frequency (P = 0.007), and bowel function (P = 0.049). Complications were minimal., Conclusions: This is the first blinded study of sacral versus pudendal stimulation for voiding dysfunction. Successful implantation of a pudendal lead was achieved in all subjects. The majority of subjects chose PNS to be superior to SNS. More patients and longer term data is needed to confirm these promising results., ((c) 2005 Wiley-Liss, Inc.)