Incontinence Episodes Research Articles

Efficacy of 100-U Onabotulinumtoxin A Treatment in Female Idiopathic Overactive Bladder-A Prospective Follow-Up Study.

Overactive bladder (OAB) affects 11-17% of the female population. First-line treatment with lifestyle modifications and second-line therapy with medications are often limited by inadequate efficacy or pharmacological side effects. This study was aimed at assessing the effect of 100 U onabotulinumtoxin A treatment on idiopathic OAB (iOAB) as a second-line treatment. This prospective follow-up study involved 94 women who received onabotulinumtoxin A treatment at a dose of 100 U as a second-line treatment for iOAB at the Department of Obstetrics and Gynecology, Oulu University Hospital, Finland, between May 2018 and December 2023. The impact of the treatment on iOAB symptoms was evaluated 3 months after administration using self-reported symptoms and the following internationally validated questionnaires: Visual Analogue Scale (VAS), Incontinence Impact Questionnaire (IIQ-7), and Urogenital Distress Inventory (UDI-6). Postoperative complications were assessed. The follow-up data were obtained from 74 (78%) patients, of whom 66 (95.7%) reported a good outcome and 3 (4.3%) reported a poor outcome. Incontinence episodes, the number of incontinence pads needed, and daily micturitions were significantly reduced. For all questionnaires, the total scores decreased significantly after the treatment (VAS 8.27 ± 1.78 vs 3.50 ± 3.08, p < 0.001; IIQ-7 72.14 ± 20.55 vs 28.73 ± 29.40, p < 0.001; UDI-6 55.01 ± 18.86 vs 29.66 ± 22.03, p < 0.001). Postoperative urinary tract infection occurred in 9 patients (9.6%), whereas urinary retention occurred in 6 patients (6.4%). Onabotulinumtoxin A (100 U) demonstrates good effectiveness in the second-line treatment of female iOAB.

Low-volume transanal irrigation (TAI) in the treatment of functional faecal incontinence in children: a cohort study

PurposeFunctional faecal incontinence (FFI) is a stigmatising condition for a child and parents and can be a challenge to treat even in tertiary centres. Transanal irrigation (TAI) is an emerging treatment with great success in refractory cases. We performed TAI with a substantially decreased amount of water used (low-volume TAI), yet no previous evidence exists on this treatment in children. We conducted this study to evaluate the efficacy of low-volume TAI in reducing faecal incontinence (FI) episodes and to provide associated factors for response.MethodsChildren with FFI trained in low-volume TAI in our outpatient incontinence clinic were identified. Baseline characteristics along with rectal ultrasound examination, information on weekly FI episodes and concomitant use of laxatives were noted. The continence status of patients was registered at the first outpatient clinic appointment after the commencement of TAI and after 6 months of treatment. During this period, information about side effects and changes in medication were captured.ResultsWe identified 47 children (mean age 8.06 ± 2.08 years, 27 males) treated with low-volume TAI. Thirty-five (74%) were diagnosed with functional constipation and FI, while 12 (26%) suffered from non-retentive faecal incontinence. Twenty (42%) children gained full faecal continence after 6.75 ± 0.3 months. We found no differences between responders and non-responders in baseline characteristics.ConclusionsLow-volume TAI appears safe and effective in the treatment of FFI refractory to first-line treatment in children. Low-volume TAI could be a valuable tool for the management of these children as the treatment is less invasive, low in cost and well accepted.

The efficacy of parasacral transcutaneous electrical nerve stimulation for the treatment of overactive bladder in children: a systematic review and meta-analysis

AimDespite the presence of published evidence in recent decades suggesting an improvement in overactive bladder (OAB) with the utilization of parasacral transcutaneous electrical nerve stimulation (PTENS), there is currently a lack of consensus guidelines for therapy. We conducted a meta-analysis to assess the impact of PTENS on children with OAB.MethodsA search was carried out using EMBASE, PubMed, and the Cochrane Controlled Register of Trials to find eligible randomized controlled trials (RCTs) published up to 1 May 2023. From the literature review, eight RCTs (351 participants) comparing PTENS and other treatments (standard urotherapy/anticholinergics/biofeedback/placebo stimulation) were considered.ResultsThe overall complete response rate with PTENS was 1.90 times that of children undergoing other treatment (relative risk 1.90, 95% confidence interval 1.45–2.49). No significant differences were observed in the mean dysfunctional voiding score system (p = 0.26), mean maximum voided volume (p = 0.79), average voided volume (p = 0.94), voiding frequency (p = 0.31), or reduction in the number of children with incontinence episodes (p = 0.81). However, regarding the reduction of children with constipation, the PTENS group demonstrated a better effect compared with the control groups (p = 0.01).ConclusionsIn summary, PTENS has demonstrated better response rates and fewer side effects compared to conventional first-line treatments, such as standard urotherapy and antimuscarinic drugs. Clinicians should consider individual circumstances when treating children with OAB. However, it is important to note that the findings of this study are limited by the small sample size and imperfect outcomes. Further high-quality RCTs are needed to establish the most effective treatment protocol.

The role of Kegel exercises in reducing involuntary loss of urine in Overactive Bladder and Mixed Urinary Incontinence

This study aimed to evaluate the efficacy of Kegel exercises, or pelvic floor muscle training (PFMT), in reducing symptoms of urinary incontinence among women with overactive bladder (OAB) and mixed urinary incontinence (MUI). A randomized control trial was conducted with a total of 50 participants (young women ages 18-35) out of which 35 were diagnosed with OAB and 15 with MUI. The participants were monitored for six months: In the first three months received only pharmacological therapy, solifenacin succinate 10 mg per day, and after this period the same group associated to the pharmacological treatment daily Kegel exercises. The primary outcome measured was the reduction in urinary incontinence episodes, while secondary outcomes included changes in quality of life (QoL) and bladder control as assessed by standardized questionnaires. After three months, group demonstrated a reduction in the frequency of urinary incontinence episodes. However, receiving both solifenacin succinate and Kegel exercises showed a statistically significant improvement in urinary control and QoL scores at six months evaluation. These findings suggest that the combination of pharmacological treatment with solifenacin succinate and Kegel exercises is more effective in managing urinary incontinence symptoms associated with OAB and MUI than pharmacological treatment alone. This approach may represent a beneficial strategy for patients requiring enhanced symptom relief.

Transcutaneous Tibial Nerve Stimulation for Urge Incontinence: A Randomized Clinical Trial

Importance Overactive bladder is a distressing syndrome that significantly affects quality of life. Transcutaneous tibial nerve stimulation (TTNS) has been proposed as a home-based, patient-centered therapy that could improve access to treatment for this condition. Objective We aimed to determine the efficacy of 12 weeks of TTNS versus sham therapy in reducing symptomatic bother in ambulatory women with urgency urinary incontinence. Study Design This was a double-masked, sham-controlled randomized trial. The primary outcome was the change in Overactive Bladder Questionnaire scores. Secondary outcomes included those with 50% or greater reduction in urgency incontinence episodes on 3-day voiding diaries and Patient Global Impression of Improvement. Results One hundred women were randomized (65 intervention, 35 sham) and included in analysis. Both groups experienced clinically meaningful improvement in Overactive Bladder Questionnaire scores postintervention from baseline, which was not significant between groups (symptom severity: intervention −19.5 ± 20.2 vs sham −19.4 ± 20.4, P = 1.0; health-related quality of life −16.6 ± 18.5 vs −13.8 ± 16.8, P = 0.5). In the TTNS group, 58.8% of women achieved 50% or greater reduction in urgency incontinence episodes versus 41.7% of women in the sham group (P = 0.2), and 25% versus 18% were “much” or “very much improved” (P = 0.2). A sensitivity analysis confirmed these findings. Conclusions Clinically meaningful reductions in overactive bladder symptoms were observed in both TTNS and sham therapy without significant differences between groups; however, a trend toward greater reduction in incontinence episodes and overall impression of improvement was noted in the active treatment. The therapeutic benefit from regularly connecting with a clinician should be considered when developing new therapies.

Collaboration introduces an innovative practice for incontinence monitoring to provide efficiencies and higher quality of care

AbstractIncontinence Management has long been overlooked as a normal part of aging and the national standard of care has become changing individuals every 2 hours. While this was effective for decades, it is no longer providing results and even more challenging for those suffering from Dementia. Over 50% of nursing home residents are incontinent with over 57% of each shift of a certified nursing aide being attributed to incontinence care and management.1Studies show that incontinence is often the root cause of wounds, infections, falls, odor, depression, and behaviors.2 Senior care has long provided care in a systematic, uniform way, not allowing for an individualized experience. Instead of making briefs more absorbent, we need to focus on real‐time changes to help mitigate health risks.Data and science behind predicting when someone will void and helping them not void in an incontinence product is the key. This is the practice of developing and implementing voiding schedules from data that are individualized to each person and providing them with the help they need and deserve. Going further into this concept, the data around patterns of voiding is also extremely powerful for care teams as over time care teams can identify outliers that can indicate to providers a brewing event or condition.Our practice innovation is a collaboration between an assisted living memory care provider and a digital health sensor platform providing a smart brief that is disposable and remotely “talks” through readers, disguised as art to alert staff to when an individual has had an incontinent episode. Data is collected and reported via a dashboard that provides real‐time alerts for the care team to make decisions on care plans and quality of care can be elevated in ways not available before.

Adult Bladder Exstrophy Managed by Complete Primary Repair: A Case Report

Bladder Exstrophic diseases, referred to collectively as Bladder Exstrophy-Epispadiasis complex, are a spectrum of embryological anomalies with a rare prevalence of approximately 3.3 per 1,00,000 live births with a male gender predominance. An 18-year-old man presented to Urology Outpatient Department (OPD) with subumbilical abdominal wall defect, absent anterior bladder wall with epispadiasis and was diagnosed as a case of adult classic bladder exstrophy with Epispadiasis complex. There was no history of any fever, haematuria, dysuria or abdominal pain. His ultrasound abdomen and intravenous pyelography reported normal kidney function. He had a low Body Mass Index (BMI) (17.5 kg/m2 ) with serum creatinine of 0.6 mg/dL. The patient underwent a complete primary repair, including bladder template closure and bladder neck reconstruction using Young-Dees-Leadbetter technique. Epispadias was repaired with the Modified Cantwell-Ransley approach. Abdominal wall defect closure was done with the help of rectus abdominis muscle flap which was later grafted using Split Thickness Skin Graft (STSG). Postoperatively, a small vesicocutaneous fistula developed which healed spontaneously over two weeks period. On follow-up patient was on clean intermittent catheterisation with some incontinence episodes during night-time. Bladder exstrophy in adult patients is rare, as the condition is usually identified in the neonatal period and can be surgically corrected early on. Due to the complexity of the surgery, these cases require thorough multidisciplinary evaluation and careful planning for successful correction.

Two-year efficacy and safety outcomes of the pivotal OASIS Study using the Revi® System for treatment of urgency urinary incontinence.

The BlueWind Medical Device, Revi®, is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (i.e., overactive bladder wet). The Revi System is the first FDA-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS Study are presented. The Revi System was implanted in 151 female participants. The primary efficacy and safety endpoints were assessed at 6- and 12-months, after which participants either consented to extend follow-up for long-term assessment of treatment durability and safety, or they chose to exit the study. Ninety-seven participants completed the 24-month assessment, and of these, 79% were therapy responders (≥ 50% reduction in urgency urinary incontinence episodes (UUIE), demonstrated on a 3-day voiding diary). Importantly, therapeutic response was durable, with comparable effectiveness at 6-, 12-, and 24-months (response rates of 78%, 82%, and 79%, respectively). Participants that completed both the 6- and 24-month assessment had similar demographics and treatment results at the 6-month visit, indicating that these results at 24-months are representative of the overall study population.In addition, high satisfaction and patient impression of improvement were reported, with 97% (88/91) of the participants satisfied with the therapy and 80% (78/97) feeling "much better" or "very much better". There were no serious adverse events related to the device or the procedure through 24 months. Two-year results demonstrate durable efficacy, high patient satisfaction, and a very favorable safety profile.

Evaluating the Efficacy and Safety of Botulinum Toxin in Treating Overactive Bladder in the Elderly: A Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials.

Overactive bladder (OAB) significantly impairs quality of life in the elderly. Although the intradetrusor injection of botulinum toxin type A (BoNT-A) is a treatment option, its effects on older adults remain uncertain. This study aimed to evaluate the efficacy and safety of BoNT-A intradetrusor injections in elderly OAB patients through a systematic review and meta-analysis. A comprehensive literature search was conducted using the PubMed, Embase, Cochrane Library, Scopus, and CINAHL databases from inception to 30 May 2024. The primary outcomes were improvements in daily urinary incontinence (UI) episodes and patient-reported outcomes, while the secondary outcomes focused on potential adverse events. Four randomized controlled trials with 803 participants were included. BoNT-A injections significantly reduced daily UI episodes at 4-6 weeks (mean difference [MD]: -3.82; 95% confidence interval [CI]: -6.29 to -1.35) and at 12 weeks (MD: -2.17; 95% CI: -3.22 to -1.12). However, BoNT-A was associated with an increased risk of elevated post-void residual (Risk Difference [RD]: 0.154; 95% CI: 0.058 to 0.251) and urinary tract infection (RD: 0.111; 95% CI: 0.005 to 0.217), with no significant difference observed in the initiation of catheterization or hematuria. Trial sequential analysis confirmed a sufficient sample size and statistical power. In conclusion, while BoNT-A effectively manages OAB in the elderly, careful post-injection monitoring is warranted due to its potential risks.

Predictive Factors for Clean Intermittent Catheterization after Intravesical OnabotulinumtoxinA Injections in Women with Overactive Bladder: a Danish Retrospective Cohort Study

Introduction and HypothesisWe aimed to evaluate the clean intermittent catheterization (CIC) rate in women undergoing their first OnabotulinumtoxinA (BTX-A) treatment and to investigate factors predictive of initiating CIC.MethodsThis was a retrospective cohort of women, who had their first BTX-A treatment for symptoms of overactive bladder (OAB) syndrome, with a pretreatment urodynamic study (UDS). We reviewed demographic, medical and gynecological history, UDS, pretreatment bladder diaries, objective examinations, BTX-A treatment details, and post-void residual (PVR) reports in the electronic medical record. Botox® Allergan 100 International Units were injected into the detrusor at 10–20 sites. Statistical analyses included univariate and multivariate logistic regression analyses.ResultsWe included 397 women. Median age was 68 (Q1–Q3: 54–76) years. CIC rate was 8.6% (n = 34) following the first BTX-A treatment. Urgency urinary incontinence (UUI) reduced the risk of undergoing CIC (OR 0.30, 95% CI 0.09–0.97). A bladder capacity of 500 ml or greater in the bladder diary increased the risk of CIC (OR 2.46, 95% CI 1.06–5.70), whereas reported leakages were associated with a decreased risk of CIC (OR 0.24, 95% CI 0.10–0.57). Multivariate logistic regression analysis showed that anterior colporrhaphy (OR 3.71, 95% CI 1.52–9.06) and 10-ml increments in median maximum cystometric capacity (OR 1.03, 95% CI 1.00–1.06) predicted CIC, whereas UUI was a protective factor for CIC (OR 0.23, 95% CI 0.07–0.79).ConclusionsA history of anterior colporrhaphy, large bladder capacity, and absence of incontinence episodes in bladder diary or UDS were risk factors for CIC after the first BTX-A treatment.

The South African guidelines on enuresis: 2024 update.

Enuresis, also referred to as nocturnal enuresis, is characterised by discrete episodes of urinary incontinence during sleep in children aged ≥5 years in the absence of congenital or acquired neurological disorders. This guideline is an update of the 2017 version. The guideline provides recommendations and suggestions for various therapeutic options for enuresis available in South Africa (SA). These options include behavioural modification, urotherapy, pharmaceutical therapy, alarm therapy, alternative therapies, neuromodulation, psychological support and biofeedback. Additionally, it explores the role of a voiding diary, additional investigations and mobile phone applications (apps) in treating enuresis. The document also outlines standardised definitions for clarity. This is an updated guideline endorsed by relevant key opinion leaders in SA, with additional input from international experts in the field.

Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta-analysis.

Implantable tibial neuromodulation (iTNM) systems have recently become commercially available in the US, and offer a new method of neurostimulation for the treatment of overactive bladder (OAB). In the absence of head-to-head studies, the aim of this meta-analysis was to indirectly compare the efficacy and safety of sacral neuromodulation (SNM) and implantable tibial neuromodulation (iTNM) for the treatment of OAB. A comprehensive search was performed using terms for OAB and neuromodulation. Primary efficacy measures included a≥50% reduction in urgency urinary incontinence (UUI) episodes, urinary frequency, and/or OAB symptoms. Primary safety measures included the rate of device-related adverse events (AEs). A total of 20 studies met selection criteria, encompassing 1416 patients treated with SNM and 350 patients treated with iTNM. No comparative or placebo-controlled studies for SNM and iTNM were identified, and therefore the analysis was completed using single-arm results. Weighted averages showed that the UUI responder rate was similar for both SNM and iTNM (71.8% and 71.3%, respectively). Similarly, weighted averages of OAB responder rates were 73.9% for SNM and 79.4% for iTNM. Similar rates of device-related AEs were also observed. This meta-analysis found similar efficacy and safety of SNM and iTNM for the treatment of OAB and UUI, including UUI and OAB symptom response rates, reduction in UUI episodes, significant improvements in quality-of-life (QoL), and low rates of procedure and device-related adverse events. Notably, this comparable efficacy was seen without the use of a trial phase of neuromodulation in the iTNM studies versus SNM studies.

Comparative Efficacy and Safety of the β3-Adrenoceptor Agonist Vibegron for Urgency and Mixed Urinary Incontinence: A Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.

Objective To compare the efficacy of vibegron for urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) in patients with overactive bladder(OAB). Methods We performed a post hoc analysis of a phase 3 study of vibegron in Japanese patients with OAB. Based on the patterns recorded in the three-day bladder diary, only female patients were categorized into UUI and MUI populations. The primary endpoint was the change in the mean micturition number per 24 hours from baseline to week 12. Other endpoints included the mean changes in urgency episodes per 24 hours, incontinence episodes per 24 hours, voided volume per micturition, and the number of nocturia episodes per night. The proportion of urinary incontinence (UI) normalization, quality of life (QOL) as measured by the King's Health Questionnaire (KHQ), and patient satisfaction level as assessed by the Patient Global Impression (PGI) were investigated. Result Data from a UUI population (vibegron 50 mg, n = 237; vibegron 100 mg, n = 231; placebo, n = 237) and an MUI population (vibegron 50 mg, n = 70; vibegron 100 mg, n = 77; placebo, n = 78) were analyzed. Vibegron 50 mg and 100 mg significantly improved the change in micturition number per 24 hours from baseline to week 12. Compared to those of patients receiving a placebo, all other endpoints of urinary parameters were significantly improved in patients receiving vibegron, except for nocturia in the vibegron 50 mg group in both populations. In the vibegron 50 mg, vibegron 100 mg, and placebo groups, the proportions of those who attained normalization of UI were stratified by the UUI (51.5%, 57.6%, and 44.7%, respectively) and MUI (40.0%, 41.6%, and 20.5%, respectively) populations. Furthermore, both vibegron doses improved KHQ scores in both populations, and PGI improvement was significantly higher than that in the placebo group in both populations. Conclusion This post hoc analysis demonstrated that vibegron has equivalent efficacy and safety in the MUI and UUI populations. The results of this study provide important information for the treatment of MUI.

Анатомічні та функціональні результати двох варіантів слінгових оперативних втручань для хірургічної корекції стресового нетримання сечі в жінок

The problem of urinary incontinence is one of the leading causes of deterioration of the quality of life of women of various age categories. Modern and effective surgical treatment of this pathology is sling surgery. Therefore, the search for the optimal variant of such an operation remains an actual direction in modern gynecology. Aim - to compare the immediate and long-term results of two variants of sling operations for stress urinary incontinence. Materials and methods. A comparative study of immediate and long-term outcomes after sling surgery for surgical correction of stress incontinence was conducted in 84 women who were divided into two groups. In the 1st group, plastic surgery with a free synthetic loop (TVT) was performed, in the 2nd group - an operation using a transobturator arrangement of a prolene loop (TVT-Obturator - TVT-О). All patients were comprehensively examined using clinical, instrumental and laboratory research methods. Statistical data processing was carried out using the SPSS 21 program. Results. The analysis of sonographic indicators of the state of the urethrovesical segment in women of both groups established a significant decrease in the angle of inclination and the posterior urethrovesical angle. There were no significant differences in these parameters between the I and II groups, which proves the comparable effectiveness of TVT and TVT-O regarding the correction of the anatomical defect. Instead, it was established that the TVT technique allows to achieve a higher frequency of cases of complete urinary continence 2 years after the operation - 87.9% versus 67.9% in the TVT-O group, as well as a lower number of urges and episodes of urge incontinence after 1 year (p=0.047 and p=0.03, respectively) and 2 years (p=0.012 and p=0.02, respectively) after sling installation. Conclusions. The obtained data indicate the anatomical efficiency of both options of sling installation, however, the efficiency of the TVT operation, according to the evaluation of the functional results of the surgical intervention, is statistically significantly higher than the TVT-O operation. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interest was declared by the authors.

Botulinum Neurotoxin Type A in paediatric non-neurogenic therapy resistant overactive bladder: a cohort study

Introduction and objectiveIntradetrusor Botulinum Neurotoxin Type A (BoNT-A) is an increasingly applied treatment modality for overactive bladder (OAB) in children with refractory urinary incontinence. Despite that, evidence is sparse, and the potential not fully understood. The aim of this study was to evaluate the effectiveness and safety of intradetrusor injection in children with refractory functional OAB and urinary incontinence. Furthermore, we aimed to identify predictors of efficacy and side effects to BoNT-A treatment.Materials and methodsWe conducted a cohort study of children with OAB and urinary incontinence who received intradetrusor injection of BoNT-A in the period 01.01.2016 to 31.12.2020 at our centre. All patients were refractory to standard urotherapy, anticholinergics, mirabegron and the combination of these treatments. Patients with neurogenic bladder were excluded.Primary endpoint was the reduction on the frequency of urinary incontinence episodes from baseline. Secondary endpoints included urodynamic parameters and uroflowmetry characteristics as well as side effects.ResultsForty-three children (mean age at first treatment 10.7 ± 1.8, 30 males) were included.After first treatment, a reduction of ≥ 50% in incontinence episodes was seen in 58% of patients with daytime urinary incontinence (DUI) and 47% of patients with nocturnal enuresis (NE). Adverse events, mainly urinary tract infections (UTI), were reported by 16% of patients after first treatment. Our analysis identified normal cystometric compliance as a significant predictor of treatment effect We estimated the mean duration of effect to be approximately 7 months.ConclusionsIntradetrusor BoNT-A injection appears to be a safe and effective option in treating refractory urinary incontinent children with overactive bladder. We identified cystometric compliance as a predictor of response. Most children necessitate repeated treatments. Further prospective and controlled studies are necessary in order to fully identify predictors and potential of treatment.

Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial.

This study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI). Adult females were randomized 2:1 to iltamiocel (150 × 106 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. 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. 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. ClinicalTrials.gov identifier: NCT01893138; EudraCT number: 2014-002919-41.

Electroacupuncture versus solifenacin succinate for female overactive bladder: study protocol for a multicentre, randomised, controlled, double-dummy, non-inferiority trial

IntroductionOveractive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for...

EP264 - Dermatofibrosarcoma protuberance of the perianal region

Abstract Introduction Dermatofibrosarcoma protuberans (DFSP) is a rare low-grade sarcoma affecting dermis and subcutaneous fat. Typically presents as slow-growing lump on the trunk, extremities or head and neck.(1) It can be locally aggressive with a high recurrence rate.(2) Only 6 reported cases of DFSP in peri-anal region. Case Description A 26-year-old male presented with slow-growing peri-anal lump for over a year with intermittent localised pain and episodes of bleeding. No other symptoms or trauma to peri-anal area noted. No relevant medical or surgical history. Examination revealed an irreducible two-by-five by one-centimetre semi-pedunculated perianal lump extending from the seven o’clock to eleven o’clock position. It was firm and tethered to the skin. Case Description Flexible sigmoidoscopy was normal. Excision biopsy histology reported diffuse infiltration of spindle cells with storiform pattern of growth without clear margins. Immunohistochemistry analysis expressed CD34 with minimal focal expression of SMA and variable Ki-67 proliferation indexed up to 15-20% in most active areas. SOX10, S100, desmin, factor XIIIA, MNF116 and CD31 were negative. Diagnosis was DFSP. Local lower gastrointestinal multi-disciplinary arranged urgent imaging and referral to tertiary centre. Magnetic resonance imaging of the pelvis identified no definite underlying localised restricted diffusion or solid enhancing nodule. Wide local excision at tertiary centre with histopathology confirmed clear margins. Conclusion Patient is under follow-up locally and at the tertiary. Urgency and a singular episode of stool incontinence was reported at two-weeks follow-up which subsequently normalised. He is currently under 3-6 monthly reviews with repeat MRI prior to next appointment. Patient has returned to normal activities.

The peptide regulator Vezusten in the management of overactive bladder syndrome: an efficacy evaluation

Introduction. Overactive bladder (OAB) remains one of the most difficult-to-treat conditions in neurourology. The number of patients seeking help for OAB symptoms does not decrease each year, while a pathogenetic treatment has not yet been developed. This motivates the search for new approaches.Objective. To assess the efficacy of the peptide regulator Vezusten for women with idiopathic OAB based on their health condition and urodynamic assessment of bacterial detrusor overactivity (DO).Materials &amp; methods. A prospective cohort study included 20 patients diagnosed with OAB, which was confirmed by a comprehensive urodynamic study of DO. The patients visited the clinic three times a week. Each patient received ten intramuscular injections of the peptide regulator Vezusten. Within one month after the last injection, the women were given a monitoring voiding diary, a validated Continental Society OAB Symptom Questionnaire, the Overactive Bladder Questionnaire (OAB-q), and a follow-up urodynamic study (UDS).Results. We obtained statistically significant differences in the following indicators: the number of daily urinations according to the urination diary decreased from 14.0 [13.0; 16.3] to 11.0 [8.8; 12.0] (p &lt; 0,001), patient’s episodes of urge incontinence began to be noted for the first time (p = 0.004). At the same time, the urodynamic maximum cystometric capacity (MCC) increased from 267 [158; 332] to 320 [267; 433] ml. Subjectively, participants noted an improvement in the scores of the OAB questionnaire (OAB-q) — the score decreased from 28 [22; 30] to 19 [14; 24] (p = 0.001), and the number of episodes of nocturia decreased from 4 to 2 (p &lt; 0.001). No side effects from therapy were observed in any of the patients.Conclusion. This study demonstrated a statistically significant improvement in subjective symptoms of OAB in DO-women treated with the peptide regulator Vezusten, but further large placebo-controlled studies are required for confirmation.

Urodynamic and Frequency-Volume Chart Parameters Influencing Anticholinergic Resistance in Patients With Neurogenic Detrusor Overactivity.

Neurogenic detrusor overactivity (NDOA) is characterized by involuntary detrusor muscle contractions during bladder filling in patients with neurological disorders. Anticholinergic therapy is the primary treatment; however, the reasons for treatment resistance in NDOA are not well understood. This study aimed to identify predictors of treatment failure by comparing urodynamic and frequency-volume chart data between patients with NDOA who respond and patients who do not respond to anticholinergic therapy. We reviewed the records of 362 patients presenting with lower urinary tract symptoms and selected 85 who had NDOA and were on anticholinergic therapy. Ultimately, 67 patients were analyzed. We categorized these individuals into responders (group R) and nonresponders (group NR) based on clinical and urodynamic improvements. Three-day frequencyvolume charts and urodynamic study results were retrospectively reviewed. Of the 85 initial patients, 12 refused medication, and 6 were lost to follow-up. Pre- to posttreatment changes differed significantly between groups in the number of urgency urinary incontinence (UUI) episodes per 24 hours (P=0.001), maximum cystometric capacity (mL, P=0.003), NDOA frequency (P=0.004), and bladder compliance (mL/cm H2O, P=0.003). Multivariate analysis revealed that NDOA frequency (P=0.014) and UUI episodes per 24 hours (P=0.002) were significant factors associated with treatment failure. NDOA varies according to underlying neurological conditions. The frequencies of UUI episodes and NDOA in urodynamic studies can predict resistance to initial anticholinergic treatment.