A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.

Current position of neuromodulation for bladder pain syndrome/interstitial cystitis.

PURPOSE OF REVIEW: Despite established effectiveness in overactive bladder and nonobstructive retention, neuromodulation's application in interstitial cystitis/bladder pain syndrome (IC/BPS) remains a topic of ongoing research. The purpose of this article is to review recent developments in neuromodulation as treatment of IC/BPS offering guidance for healthcare practitioners dealing with IC/BPS cases. RECENT FINDINGS: Recent research underlines the promising role of sacral, tibial and pudendal neuromodulation in management of IC/BPS symptoms. Studies reveal encouraging outcomes, particularly in alleviating urgency and frequency symptoms. However, while urgency and frequency symptoms tend to improve, comprehensive pain relief remains a challenge. Percutaneous tibial nerve stimulation (PTNS) and transcutaneous tibial nerve stimulation (TTNS) stand out due to their minimal invasive nature. Existing literature points to the need for larger prospective studies with extended follow-up periods to validate the efficacy and sustainability of neuromodulation. SUMMARY: Neuromodulation is a promising treatment modality for refractory IC/BPS. Due to the minimal invasive nature, they should be tried before rigorous surgery. However, the limited quantity of available data and the variability in pain relief outcomes necessitate cautious interpretation. The review emphasizes the need for further research.

What Is in the Pipeline on Investigational Neuromodulation Techniques for Lower Urinary Tract Dysfunction: A Narrative Review.

OBJECTIVES: Overactive bladder (OAB) affects millions of patients worldwide. Its treatment is challenging but improves the patient's quality of life. Besides standard techniques for neuromodulation (sacral and pudendal neuromodulation and posterior tibial nerve stimulation), several new techniques have been investigated to treat symptoms of refractory OAB. The purpose of the present review is to outline the state of the art of new neuromodulation techniques for lower urinary tract dysfunction (LUTD). MATERIALS AND METHODS: In March 2023, a comprehensive MEDLINE, EMBASE, and Scopus search was carried out (keywords: LUTD, new technologies, neuromodulation, LUTS, OAB, painful bladder syndromes, etc). Articles were included according to inclusion (randomized controlled trials, prospective trials, large retrospective studies) and exclusion (case reports, outcomes not clearly expressed in full text, animal studies) criteria. The reference lists of the included studies also were scanned. Both adult and pediatric populations were included, in addition to both neurogenic and nonneurogenic OAB. A narrative review was then performed. RESULTS: Peroneal neuromodulation, transcutaneous electrical nerve stimulation, magnetic nerve stimulation, and parasacral transcutaneous neuromodulation are the most studied investigative techniques and were shown to yield promising results in treating OAB symptoms. Most studies showed promising results even in the complex scenarios of patients with OAB refractory to standard treatments. Comparing investigational techniques with standard of care and their respective clinical outcomes and safety profiles, and confronting their pros and cons, we reasonably believe that once such treatment modalities are further developed, they could play a role in the OAB treatment algorithm. CONCLUSIONS: Although the described neuromodulation techniques are being intensely studied, the available results are not yet sufficient for any guidelines to recommend their use.

The Maximal Urethral Pressure at Rest and during Normal Bladder Filling Is Only Determined by the Activity of the Urethral Smooth Musculature in the Female.

The aim of this opinion paper is to determine the entities that define the maximal urethral pressure (MUP) during rest and during bladder filling that is needed to guarantee continence in females. For the development of this opinion, the literature was searched for via the Pubmed database and historic sources. Animal studies indicate that the maximal urethral pressure is determined by the smooth muscle activity in the mid-urethra. Additionally, during increased smooth muscle tone development, the largest sympathetic responses are found in the middle part of the urethra. This could be confirmed in human studies that are unable to find striated EMG activity in this area. Moreover, the external urethral striated sphincter is situated at the distal urethra, which is not the area with the highest pressure. The external urethral sphincter only provides additional urethral pressure in situations of exertion and physical activity. From a physics point of view, the phasic pressure of the external striated sphincter at the distal urethra cannot be added to the tonic pressure generated by the smooth muscle in the mid-urethra. The assertion that mid-urethral pressure is the result of different pressure forces around the urethra, including that of the external striated sphincter, is not supported by basic research evidence combined with physical calculation and should therefore be considered a misconception in the field of functional urology.

Cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® compared with mid-urethral sling surgery for stress urinary incontinence: A two-arm cohort study.

OBJECTIVE: To investigate the cost-effectiveness of urethral bulking polydimethylsiloxane-Urolastic® (PDMS-U) compared with mid-urethral sling (MUS) surgery for stress urinary incontinence (SUI) at 1-year follow-up. DESIGN: Prospective, two-arm cohort study with 2-year follow-up. SETTING: International multicentre. POPULATION: Women with moderate to severe SUI. MAIN OUTCOME MEASURES: Primary outcome was subjective cure (Patient Global Impression of Improvement). SECONDARY OUTCOMES: objective cure (negative cough stress test), Urogenital Distress Inventory (UDI-6), complications and re-interventions. Cost-effectiveness outcomes: total costs, quality-adjusted life year (QALY) using IIQ7-scores (Incontinence Impact Questionnaire) and EQ-5D-5L, incremental cost-effectiveness ratio (ICER) and monetary benefit (adjusted for baseline confounders). RESULTS: In all, 131 PDMS-U and 153 MUS surgery patients were treated. Subjective cure rates for MUS surgery and PDMS-U were, respectively: 101/112 (90%) versus 40/87 (46%), adjusted odds ratio (aOR; for age, body mass index [BMI], severity, type of urinary incontinence and previous SUI procedure) was 4.9. Objective cure rates for MUS surgery and PDMS-U were respectively: 98/109 (90%) versus 58/92 (63%), aOR 5.4. Average total costs for PDMS-U and MUS surgery were €3567 and €6688. ICER for MUS surgery cost €15 598 per IIQ QALY and €37 408 per EQ-5D-5L QALY. With a willingness to pay (WTP) of €25 000, MUS has a 84% chance of being cost-effective using IIQ, whereas PDMS-U has a 99% chance of being cost-effective using EQ-5D-5L. CONCLUSION: MUS surgery is more cost-effective in realising improved disease-specific quality of life (QoL), while PDMS-U is more cost-effective in realising improved generic QoL.

Physicians' perspectives on using a patient decision aid in female stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: A treatment choice for female stress urinary incontinence (SUI) is preference sensitive for both patients and physicians. Multiple treatment options are available, with none being superior to any other. The decision-making process can be supported by a patient decision aid (PDA). We aimed to assess physicians' perceptions concerning the use of a PDA. METHODS: In a mixed methods study, urologists, gynecologists and general practitioners in the Netherlands were asked to fill out a web-based questionnaire. Questions were based on the Tailored Implementation for Chronic Diseases checklist using the following domains: guideline factors, individual health professional factors, professional interactions, incentives and resources, and capacity for organizational change. Participants were asked to grade statements using a five-point Likert scale and to answer open questions on facilitators of and barriers to implementation of a PDA. Outcomes of statement rating were quantitatively analyzed and thematic analysis was performed on the outcomes regarding facilitators and barriers. RESULTS: The response rate was 11%, with a total of 120 participants completing the questionnaire. Ninety-two of the physicians (77%) would use a PDA in female SUI. Evidence-based and unbiased content, the ability to support shared decision making, and patient empowerment are identified as main facilitators. Barriers are the expected prolonged time investment and the possible difficulty using the PDA in less health-literate patient populations. CONCLUSIONS: The majority of physicians would use a PDA for female SUI. We identified facilitators and barriers that can be used when developing and implementing such a PDA.

Posterior Tibial Nerve Stimulation in Children with Lower Urinary Tract Dysfunction: A Mixed-Methods Analysis of Experiences, Quality of Life and Treatment Effect.

BACKGROUND: Posterior tibial nerve stimulation (PTNS) is one of the treatment modalities for children with therapy-refractory lower urinary tract dysfunction (LUTD). This study used a mixed-methods analysis to gain insight into the experiences of children treated with PTNS and their parents, the effect of treatment on quality of life (QOL) and the effect of PTNS on urinary symptoms. METHODS: Quantitative outcomes were assessed through a single-centre retrospective chart analysis of all children treated with PTNS in a group setting between 2016-2021. Voiding parameters and QOL scores before and after treatment were compared. Qualitative outcomes were assessed by an explorative study involving semi-structured interviews transcribed verbatim and inductively analysed using the constant-comparative method. RESULTS: The data of 101 children treated with PTNS were analysed. Overall improvement of LUTD was seen in 42% and complete resolution in 10%. Average and maximum voided volumes significantly increased. QOL improved in both parents and children independent of the actual effect on urinary symptoms. Interviews revealed PTNS to be well-tolerated. Facilitating PTNS in a group setting led to feelings of recognition in both children and parents. CONCLUSIONS: PTNS is a good treatment in children with therapy-refractory LUTD and provides valuable opportunities for peer support if given in a group setting.

The functioning and the complication rate of extreme long existing urinary diversions.

PURPOSE OF REVIEW: This review is timely and relevant because many patients live many years with urinary diversions. Knowledge about the long term outcome with respect to function and complications are important for patient counseling and for the manner to follow-up patients. This study was performed to investigate the functioning of urinary diversions constructed > 25 years earlier. RECENT FINDINGS: Most studies have a relatively shorter follow-up, mainly focussing on short term postoperative complications. Focussing on the long term, urinary tract infections (UTI) including pyelonephritis are common. Mild kidney function deterioration is described. SUMMARY: Retrospective study (2018-2019); 43 patients with regular follow-up at the Radboud University Medical Centre Nijmegen the Netherlands. Ileal conduit (n = 19) and ureterosigmoidostomy (n = 11) are the most common diversion types for reasons such as: bladder exstrophy (n = 15), urinary incontinence (n = 9) and malignancy (n = 8). This series with a median follow-up of 40 years, shows it is possible to live and cope with a urinary diversion for a very long time. Ureterosigmoidostomies give relatively good results. Ileal conduits are functioning properly with acceptable complication rates. 95% suffers from chronic UTI's. Kidney function deterioration was mild. Diversions for benign reasons have more complex complications compared to diversion constructed for malignant reasons. VIDEO ABSTRACT: http://links.lww.com/COU/A32.

Urodynamic Effects of Prostatic Urethral Lift Procedure for Male Voiding Lower Urinary Tract Symptoms.

Aims: Primary objective is to investigate whether prostatic urethral lift (PUL) results in an improvement of urodynamic parameters that define bladder outlet obstruction (urethral resistance algorithm [urethral resistance factor (URA)], Schäfer grade, detrusor pressure at maximum flow [PdetQmax], and detrusor pressure at bladder opening [PdetOpen]). Materials and Methods: Twenty patients (main inclusion criteria: ≥50 years of age, benign prostatic obstruction (BPO), international prostate symptom score (IPSS) ≥13, prostate volume ≤60 mL, and no middle prostate lobe) were enrolled in the study and a PUL was performed. Patients underwent urodynamic investigation and filled out the IPSS and quality of life (QoL) before and after PUL. A paired t-test was used to analyze the results. Results: The mean age was 68 years (range 55-79), mean prostate volume (TRUS) was 45 mL (range 20-59), and mean prostate-specific antigen was 2.0 µg/L (0.2-4.4). IPSS of the 16 patients reduced significantly (from 22.20 to 14.47, p = 0.000). Qmax during pressure flow study improved significantly (from 4.5 to 7.2 mL/s, p = 0.001), no significant difference was found in Qmax during free uroflowmetry. There was no significant difference found in postvoiding residual. URA decreased significantly post-treatment (from 52 to 37 cmH2O, p = 0.000). The Schäfer obstruction plot decreased significantly (from 3.5 to 2.6, p = 0.022). Seven patients underwent Greenlight Laser Vaporization of the prostate after the PUL attributable to unsatisfactory results. Conclusions: PUL has desobstructive effects, but they seem clinically modest. The procedure improves urodynamic parameters as well as QoL in males with lower urinary tract symptoms based on BPO. However, the mechanism how PUL leads to a remarkable symptom relief remains unclear and cannot be explained by the desobstructive mechanisms we observed.

Patient-reported outcomes and health-related quality of life after urinary diversions.

PURPOSE OF REVIEW: To study the recent literature on health-related quality of life (HRQOL) in patients after radical cystectomy followed by urinary diversion. RECENT FINDINGS: General consensus regarding, which urinary diversion is superior in terms of HRQOL has not been reached. Although there is an increase in studies favoring the orthotopic neobladder, overall quality of these studies is poor. Other studies suggest that HRQOL outcomes in different types of urinary diversions is similar and that other factors, such as age, comorbidities and sex are more important instead. Patient choice, in consultation with the treating surgeon should be the determinant of which urinary diversion is performed. Furthermore, sexual function can play an important role in HRQOL. However, practice shows that counselling on the option of sexual-preserving techniques is still not implemented in routine clinical practice. Furthermore, studies regarding differences in HRQOL after urinary diversion between male and female individuals are lacking. SUMMARY: Thorough preoperative counselling on the different types of urinary diversion and options for sexual-preserving techniques decreases decision regret and increases HRQOL in patients after radical cystectomy.

Imaging findings of vinyl dimethyl polydimethylsiloxane used as a paraurethral injectable for female stress urinary incontinence.

OBJECTIVES: Vinyl dimethyl polydimethylsiloxane (VDPDMS) is a urethral bulking agent used for female stress urinary incontinence (SUI), that is clearly visible on computed tomography (CT). Clinical effects are promising, but it remains difficult to identify factors predicting clinical success. Clinical outcome might depend on the shape and position of the implants after injection. Objective of this study is to analyze the appearance and position of bulk material on CT scans and to see whether it is delivered the intended circumferential and mid-urethral position. METHODS: A single-center retrospective study was performed in 20 women, treated with VDPDMS for SUI. A senior radiologist analyzed all CTs, using an assessment scheme. This scheme describes whether the bulk is scattered, mid-urethral, and/or circumferentially distributed. The imaging findings were subsequently correlated to the patient global impression of improvement (PGI-I) and the percentage of subjective improvement experienced 6 weeks post-operatively. RESULTS: The patient's mean age was 61 years, and they underwent median 2.0 previous surgical treatments for SUI. Three patients reported no improvement, 9 patients had 20-90% improvement and 8 reported >90% improvement of their SUI. In 17/74 (24%) positions, the implant was scattered rather than spherical. In 9/20 (45%), the implants were not located in the intended mid-urethral position. In 8/20 patients (40%), the material was distributed circumferentially. CONCLUSION: This is the first study describing the position and shape of VDPDMS in patients after treatment. The appearance and position of the implants appears to be variable, but optimal positioning or shape seems to be no absolute requisite for success.

Pain after midurethral sling; the underestimated role of mesh removal.

INTRODUCTION: The primary aim of this study was to evaluate the results of midurethral sling (MUS) removal in women who have pain as their single complication of MUS. MATERIAL AND METHODS: We performed a retrospective chart study supplemented with a cross sectional questionnaire. Women who underwent MUS removal for pain as the solitary reason for removal between 2004 and 2018 were included. Primary outcome was change in pain levels assessed by the visual analogue scale (VAS) pain score (range 0-10). Secondary outcome was the recurrence of stress urinary incontinence (SUI). RESULTS: Twenty-six of 31 patients returned the questionnaire. Median medical file follow-up was 12 months (range 2-66) and 25 months (range 5-104) regarding questionnaires. VAS pain score dropped from 7.8 (SD 1.9) at baseline to 4.5 (SD 3.2) at follow-up (p <.00). Seven (23%) patients were pain-free. Patients undergoing partial vaginal resection (n = 6) had a VAS pain score decrease of 4.7 (p = .02) versus 2.7 (p = .02) for complete vaginal removal (n = 14). Twenty-three (89%) patients experienced SUI at follow-up, whereof 10 (45%) reported (almost) no incidents of SUI. CONCLUSIONS: MUS removal is a viable and safe option with a significant drop in VAS pain score in patients with chronic pain after MUS placement. A post-operative increase of SUI and a possible renewed wish for SUI treatment have to be considered. This should not be a reason to refrain from information and/or referral for surgical removal.

Genetic variants and expression changes in urgency urinary incontinence: A systematic review.

AIM: To perform a systematic review summarizing the knowledge of genetic variants, gene, and protein expression changes in humans and animals associated with urgency urinary incontinence (UUI) and to provide an overview of the known molecular mechanisms related to UUI. METHODS: A systematic search was performed on March 2, 2020, in PubMed, Embase, Web of Science, and the Cochrane library. Retrieved studies were screened for eligibility. The risk of bias was assessed using the ROBINS-I (human) and SYRCLE (animal) tool. Data were presented in a structured manner and in the case of greater than five studies on a homogeneous outcome, a meta-analysis was performed. RESULTS: Altogether, a total of 10,785 records were screened of which 37 studies met the inclusion criteria. Notably, 24/37 studies scored medium-high to high on risk of bias, affecting the value of the included studies. The analysis of 70 unique genes and proteins and three genome-wide association studies showed that specific signal transduction pathways and inflammation are associated with UUI. A meta-analysis on the predictive value of urinary nerve growth factor (NGF) levels showed that increased urinary NGF levels correlate with UUI. CONCLUSION: The collective evidence showed the involvement of two molecular mechanisms (signal transduction and inflammation) and NGF in UUI, enhancing our understanding of the pathophysiology of UUI. Unfortunately, the risk of bias was medium-high to high for most studies and the value of many observations remains unclear. Future studies should focus on elucidating how deficits in the two identified molecular mechanisms contribute to UUI and should avoid bias.

3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome.

PURPOSE: We evaluated the 3-year safety and efficacy of the BlueWind Medical RENOVA™ iStim system for the treatment of overactive bladder syndrome. MATERIALS AND METHODS: All patients who previously underwent implantation with the RENOVA system were offered continued participation. The primary long-term study end point was to evaluate the safety profile based on incidence of serious adverse events (system and/or procedure related), which was measured by the impact and frequency of serious adverse events. The secondary end points included clinical improvement compared to baseline and quality of life improvement compared to baseline at 36 months, which was measured by 3-day voiding diary and quality of life questionnaires at certain time points. RESULTS: Of the 34 patients with overactive bladder syndrome who previously underwent implantation with the RENOVA system 20 consented to continuation in this 3-year followup study. Mean patient age was 56.1 years and 80% (16) of the study cohort was female. The overall treatment success rate was 75% at 36 months in the per protocol (16) and the intent to treat (20) analyses. In total, 73% of the patients reported improvement in health related quality of life scores above the minimal important difference of 10 points. CONCLUSIONS: This 3-year followup study using the BlueWind RENOVA iStim system for the treatment of overactive bladder syndrome symptoms confirms the long-term good safety profile with no technical failures reported. Lasting treatment efficacy is mirrored by a sustained positive impact on patient quality of life.

Results of the York Mason Procedure with and without Concomitant Graciloplasty to Treat Iatrogenic Rectourethral Fistulas.

BACKGROUND: Rectourethral fistulas (RUFs) are rare but devastating complications after surgery or radiation therapy to the urethra, prostate, or rectum. RUF repair is challenging, especially in irradiated patients. OBJECTIVE: To evaluate the efficacy of the York Mason (YM) procedure with or without concomitant gracilis muscle interposition (graciloplasty) for RUF repair. DESIGN, SETTING, AND PARTICIPANTS: Records of patients with an iatrogenic RUF who underwent the YM procedure between 2008 and 2018 in two university hospitals were reviewed. Data on etiology, diagnostic and operative procedures, urinary and fecal diversion, and postoperative follow-up were collected. INTERVENTION: Twenty-eight patients underwent 33 YM procedures. Concomitant graciloplasty was performed in four (14%) primary repairs and two (7%) repairs for recurrent RUFs. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was successful RUF repair, defined as absence of symptoms and no leakage on control urethrocystography. The secondary endpoint was colostomy reversal rate. RESULTS AND LIMITATIONS: Median follow-up was 24 mo. Ten patients (36%) were irradiated previously. The ultimate success rate was 75% after a maximum of three YM procedures. Success rates were 89% and 50% in patients with nonirradiated and irradiated fistulas, respectively. In irradiated patients, the success rates of the first YM procedure with and without graciloplasty were 100% and 29%, respectively. In recurrent cases, concomitant graciloplasty did not result in better outcomes. Colostomy reversal was possible in 15 patients after successful repair. In all patients, fecal continence was intact and no anal stenosis was reported. Limitations of the study include small sample size and the retrospective design. CONCLUSIONS: Combination of the YM procedure with graciloplasty resulted in higher success rates of RUF repair in patients with irradiated fistulas. Fecal continence was preserved, and colostomy reversal is feasible. PATIENT SUMMARY: We analyzed the outcomes, complications, and colostomy reversal rate of the York Mason procedure for the repair of rectourethral fistulas (RUFs). We found that concomitant graciloplasty increases success rates in case of prior radiation therapy. Colostomy reversal is feasible after RUF repair.

Long-term real-life adherence of percutaneous tibial nerve stimulation in over 400 patients.

BACKGROUND: Percutaneous tibial nerve stimulation (PTNS) is used as a treatment to reduce the complaints of overactive bladder (OAB). Although it is rewarding therapy patients need maintenance treatment to preserve the beneficial effect. AIM: This real-life retrospective study was performed to assess the feasibility of PTNS adherence. MATERIALS & METHODS: All patients who underwent PTNS were retrospectively included. We analyzed the following: indication, kind of treatments (pharmacologic and third-line therapy) before and after PTNS treatment, time and reason for quitting therapy. Statistical analysis was done by performing competitive-risk analysis and Kaplan-Meier curves. Patients were categorized into four groups. Group 1: all patients; group 2: all patients on maintenance PTNS therapy (continuing after 12 weeks); group 3: patients on maintenance PTNS therapy excluding the following: (a) patients with initial good response who seized treatment due to death, (b) patient who successfully switched to transcutaneous stimulation, (c) patients who were cured of their OAB symptoms, or (d) patients who relocated; and group 4: group 3 but excluding those who stopped treatment because of nonmedical reasons (physical strain, inconveniencies associated with visiting the hospital). RESULTS: Four-hundred two patients (70% female) with a median age of 70 years underwent PTNS. Underlying treatment indications were: OAB-wet (54%) and OAB-dry (29%). The median follow-up (FU) of group 1 was 4 months. Fifty-seven percent (N = 228) of the patients received maintenance PTNS therapy. Median FU in group 4 was 46 months (range, 3-111 months). Over 40% of the maintenance patients stopped PTNS because of logistic reasons and physical strain during an FU time of 6 years. CONCLUSION: The real-world data described here with is in line with earlier published work in terms of the success rate of OAB treatment. However, over 40% quit their therapy due to nonmedical reasons.