Frequency Of Incontinence Episodes Research Articles

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

Intradetrusor 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. We 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. Forty-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 7months. Intradetrusor 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.

Efficacy and Safety of TAS-303 in Female Patients With Stress Urinary Incontinence: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.

We aimed to evaluate the therapeutic efficacy and safety of TAS-303, a highly selective noradrenaline reuptake inhibitor, in Japanese women with stress urinary incontinence (SUI). A double-blind, placebo-controlled, phase 2 study randomized women with SUI symptoms to once-daily oral administration of TAS-303 18 mg or placebo for 12 weeks. The primary endpoint was percent change from baseline to Week 12 in mean SUI episode frequency per 24 hours (SUIEF) in the per-protocol set. The secondary endpoints were the proportion of patients with ≥ 50% reduction in mean SUIEF, incontinence episode frequency, incontinence amount, health-related quality of life, and safety in the full analysis set. In total, 231 patients were randomized to TAS-303 (n = 116) or placebo (n = 115). At Week 12, TAS-303 had superior efficacy to placebo, with a least squares mean percent change in mean SUIEF of -57.7% vs -46.9%, respectively, in the per-protocol set (least squares mean difference -10.8%; P = .036). TAS-303 showed some evidence of improved incontinence episode frequency, incontinence amount, and health-related quality of life (although not statistically significant) at Week 12 vs placebo in the full analysis set. The between-group difference in SUIEF improvement was more clearly confirmed in patients with ≥ 2 SUI episodes daily at baseline. All adverse events (AEs) with TAS-303 were mild or moderate; there were no serious AEs, AEs leading to discontinuation, or nervous system- or gastrointestinal-related (eg, nausea or vomiting) adverse drug reactions. Once-daily TAS-303 18 mg showed superior efficacy to placebo for the treatment of SUI in Japanese women, with an adequate safety profile. ClinicalTrials.gov: NCT04512053; Japan Registry of Clinical Trials: jRCT2080225307 (JapicCTI-205403 before site integration).

Lower Urinary Tract Symptoms, Toileting Behaviors, and Pelvic Floor Health Knowledge in Younger and Older Women.

The primary aim was to examine the relationship between lower urinary tract symptoms (LUTS), toileting behaviors, and pelvic floor health knowledge in younger and older women. The secondary aim was to compare LUTS, toileting behaviors, and pelvic floor health knowledge in younger and older women. The study included 85 younger women and 81 older women. LUTS were evaluated using the International Consultation on Incontinence Questionnaire-Female LUTS (ICIQ-FLUTS), toileting behaviors using Toileting Behavior-Women's Elimination Behaviors (TB-WEB), and pelvic floor health knowledge using the Pelvic Floor Health Knowledge Quiz (PFHKQ). In terms of LUTS, the most common symptoms in younger women are urgency (31.8%), bladder pain (28.2%), and frequency of incontinence episodes (35.3%), whereas in older women, the most common symptoms observed are urgency (64.2%), frequency of incontinence episodes (61.7%), intermittency (46.9%), urgency urinary incontinence (58%), and frequency of incontinence episodes (49.4%). Most unhealthy toileting behaviors correlated with LUTS in both groups (p < 0.05). Although a weak negative correlation was detected between ICIQ-FLUTS total score and PFHKQ function in younger women (p < 0.05), no correlation was found in older women (p < 0.05). Whereas premature voiding, straining during voiding, TB-WEB total score were higher in older women than in younger women (p < 0.05), delayed voiding, position preference for voiding, and PFHKQ function/dysfunction scores were higher in younger women than in older women (p < 0.05). Within the scope of preventive health services, it may be important to provide informative programs on healthy toileting behaviors and pelvic floor health to women of all ages in order to prevent LUTS.

Results of a study examining the use of onabotulinumtoxinA in pediatric patients with overactive bladder

There is a lack of approved treatments for pediatric patients with overactive bladder (OAB) with inadequate response to anticholinergic therapy. OnabotulinumtoxinA 100U is approved to treat OAB in adults based on data from randomized, pivotal trials. To investigate the efficacy and safety of onabotulinumtoxinA treatment of OAB in children aged 12-17 years who were not adequately managed with anticholinergics. In this multinational, multicenter, randomized, double-blind, parallel-group, multiple-dose study (NCT02097121), pediatric patients with OAB were randomized 1:1:1 to receive onabotulinumtoxinA 25U, 50U, or 100U (≤6U/kg). Patients could request retreatment starting at week 12. The primary endpoint was change from baseline to week 12 after treatment 1 in daily frequency of daytime urinary incontinence (UI) episodes. Safety assessments evaluated treatment-emergent adverse events (TEAEs). Of 68 screened patients, 55 received ≥1 treatment. Mean age was 14 years; 85.5% of patients were female. At week 12 after treatment 1, least squares mean change from baseline in daily frequency of daytime UI episodes showed a numerically greater reduction in the 100U arm (-2.4) versus the 25U arm (-1.4; P=0.38), with a significant within-group change from baseline in the 100U arm (P=0.0027). Achievement of treatment response was significantly greater with onabotulinumtoxinA 100U vs 25U (Figure). Median time to request retreatment was ≥16 weeks in all groups. The most frequently reported TEAEs were nasopharyngitis (10.9%) and urinary tract infection (UTI; 10.9%). Urinary retention was observed in 1 patient during treatment cycle 2; there were no serious TEAEs of UTI or urinary retention. Throughout 2 additional treatment cycles continued efficacy for the 100U dose arm was observed along with a consistent safety profile. Change in daily frequency of UI episodes at week 12 in treatment cycle 1 was not significantly different between arms. However, ≥50% response rate was significantly higher with onabotulinumtoxinA 100U versus 25U. Enrollment challenges that lowered the sample size could have reduced statistical power. Also, the lack of a placebo arm and the observed benefit with the 25U comparator limited interpretation. OnabotulinumtoxinA injections were well tolerated in children with OAB at all doses studied. Although the primary endpoint was not met, the significantly greater treatment response rate observed with onabotulinumtoxinA 100U versus 25U suggests additional benefit of the higher dose, without additional safety concerns.

The effect of duloxetine on stress urinary incontinence.

This study aims to evaluate the effect of duloxetine on stress urinary incontinence (SUI) episode frequency (IEF) per week IEF. In this clinical trial, 100 women aged 20-80 years with urinary incontinence were assessed based on the standard questionnaire of urinary tract disorders. All the patients received a placebo for 2 weeks. Patients were then randomly divided into two groups of 50 patients each, receiving duloxetine (40 mg twice a day for 12 weeks) and placebo. The two groups were compared in terms of IEF and the mean score of quality of life and side effects. The two groups of duloxetine and placebo recipients were matched at the beginning of the study in terms of age, BMI, IEF, parity, and type of delivery. IEF significantly decreased in the duloxetine recipient group compared to the placebo group. The mean score of quality of life in the duloxetine recipient group increased significantly. The rate of study abandonment in the duloxetine recipient group was significantly higher than in the placebo group. Vertigo was the most common complication that caused patients to discontinue the use of the drug. Duloxetine is therapeutically effective for SUIin women. Patients should be provided information regarding potential side effects and their management.

Optimized electroacupuncture treatment for female stress urinary incontinence: study protocol for a multi-center randomized controlled trial.

Stress urinary incontinence (SUI) is a common condition that can severely affect women's life quality. Electroacupuncture (EA) has been proved to be an optional treatment for SUI, but the tolerance of EA becomes a factor affecting efficiency, which should not be ignored and needs to be solved urgently. The purpose of this study is to find out whether the use of alternating acupoints combination can solve this problem or not and provide an optimization of EA treatment for female SUI. This multi-center randomized controlled trial will enroll 360 patients with SUI. They will be randomly assigned to one of the three groups-sacral acupoints group (sacral group), abdominal acupoints group (abdominal group), or alternating acupoints group (alternating group)-at a 1:1:1 ratio. The patients will receive 18 sessions of EA treatment and will be followed up for 48 weeks after the treatment. The primary outcome measure of the study is the change of urine leakage at week 6. The secondary outcomes include the incontinence episode frequency (IEF), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), severity of SUI, patient self-evaluation of therapeutic effects, weekly usage of urine pads, ultrasonography of pelvic floor, specialty therapies for SUI, evaluation of discomfort during EA treatment, patient acceptability evaluation and adverse events related to intervention. This trial is specifically designed to offer an optimized EA treatment for female SUI, aiming to enhance their quality of life.Clinical trial registration: ClinicalTrials.gov, identifier ID:NCT05635669.

Skeletal Muscle–Derived Cell Implantation for the Treatment of Fecal Incontinence: A Randomized, Placebo-Controlled Study

Fecal incontinence (FI) improvement following injection of autologous skeletal muscle-derived cells has been previously suggested. This study aimed to test the efficacy and safety of said cells through a multicenter, placebo-controlled study, to determine an appropriate cell dose, and to delineate the target patient population that can most benefit from cell therapy. Patients experiencing FI for at least 6 months were randomized to receive a cell-free medium or low or high dose of cells. All patients received pelvic floor electrical stimulation before and after treatment. Incontinence episode frequency (IEF), FI quality of life, FI burden assessed on a visual analog scale, Wexner score, and parameters reflecting anorectal physiological function were all assessed for up to 12 months. Cell therapy improved IEF, FI quality of life, and FI burden, reaching a preset level of statistical significance in IEF change compared with the control treatment. Post hoc exploratory analyses indicated that patients with limited FI duration and high IEF at baseline are most responsive to cells. Effects prevailed or increased in the high cell count group from 6 to 12 months but plateaued or diminished in the low cell count and control groups. Most physiological parameters remained unaltered. No unexpected adverse events were observed. Injection of a high dose of autologous skeletal muscle-derived cells followed by electrical stimulation significantly improved FI, particularly in patients with limited FI duration and high IEF at baseline, and could become a valuable tool for treatment of FI, subject to confirmatory phase 3 trial(s). (ClinicalTrialRegister.eu; EudraCT Number: 2010-021463-32).

Short-term effect of magnetic stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial.

To evaluate the efficacy of magnetic stimulation (MStim) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB). Seventy-six women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n: 38), and Group 2 received BT + MStim (n: 38). MStim was performed with MStim therapy armchair (Novamag NT60), 2 days a week, 20 min a day, a total of 12 sessions for 6 weeks. Women were evaluated in terms of incontinence severity (24-h pad test), 3-day voiding diary (frequency of voiding, incontinence episodes, nocturia, and number of pads), symptom severity (OAB-V8), QoL (IIQ-7), positive response and cure-improvement rates, and treatment satisfaction (Likert scale) at the baseline and the end of treatment (sixth week). A statistically significant improvement was found in incontinence severity, frequency of voiding, incontinence episodes, nocturia, number of pads, symptom severity, and QoL parameters for two groups at the end of the treatment compared to the baseline values (p < 0.05). At the end of treatment; incontinence severity, incontinence episodes, nocturia, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p < 0.05). No difference was found between the two groups in terms of frequency of voiding (p > 0.05). The positive response and cure-improvement rates, and treatment satisfaction were significantly higher in Group 2 than in Group 1 (p < 0.05). MStim added to BT is more effective than BT alone in women with idiopathic OAB.

Effect of Acupuncture for Mixed Urinary Incontinence in Women: A Systematic Review

BackgroundMixed urinary incontinence increasingly undermines women's quality of life. Previous studies showed some effects of acupuncture for MUI, but no systematic review has been done to evaluate the efficacy and safety of acupuncture for MUI in women.ObjectiveTo systematically review the efficacy and safety of acupuncture for women with MUI.MethodsTen databases (i.e., PubMed, Web of Science, Embase, ClinicalTrials.gov, the Cochrane Library, CBM, Scoups, CNKI, VIP and WANFANG DATA) were searched up to July 19th, 2021, using tailored search strategies with keywords not limited to “female,” “mixed urinary incontinence,” “acupuncture,” and “randomized controlled trial,” etc. RCTs and quasi-RCTs were included if investigating effect of any type of acupuncture for female patients with MUI. Data were extracted from eligible studies, and risks of bias were assessed according to the Cochrane Handbook from seven aspects using the RevMan 5.4 software.ResultsA total of three randomized studies with 591 women were included. The risk of bias among the studies varied, with major concerns on blinding of participants and outcome assessor. Liu's study (497) mainly showed that electroacupuncture's effect on reduction of numbers of incontinence, urgency, nocturia episodes, and amount of urine leakage etc. was not inferior to that of PFMT-Solifenacin group at 12, 24, and 36 weeks. Zhan's study (60) showed that electroacupuncture reduced significantly more amount of urine leakage than Tolterodine at 8 weeks, with no data on incontinence episodes frequency. All 3 studies reported that acupuncture significantly increased the quality of life assessed by ICIQ score. In addition, incidence of acupuncture-related adverse events was rare, while antimuscarinic agents related adverse events were common in two studies.ConclusionAlthough acupuncture showed some benefit for women with MUI, more evidences were required to draw a solid conclusion of effectiveness and safety of acupuncture for women with MUI.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO, identifier: CRD42021224600.

Hengli® Chinese Botulinum Toxin Type A for Treatment of Patients With Overactive Bladder: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

Objective: To evaluate the efficacy and safety of Hengli® Chinese botulinum toxin type A (BTX-A; 100 U) in Chinese patients with overactive bladder. Methods: This study was a multicenter, randomized, double-blind, placebo-controlled trial in Chinese patients who were inadequately managed with anticholinergic medications. Eligible patients were randomized 2:1 to receive intradetrusor injections of Hengli® BTX-A (n = 144) or placebo (n = 72). The primary endpoint was the change in the number of daily micturition episodes at week 6 from baseline. The secondary efficacy endpoints included the average frequency of urgency and urinary incontinence (UI) episodes per day, urgency score, average micturition volume per day, OABSS, and QoL score. Results: In the Hengli® BTX-A group, there was a significantly greater reduction in the average number of micturition episodes per 24 h compared with the placebo group (3.28 vs. 1.43; p = 0.003). Moreover, there was a significantly greater improvement in the daily number of urgency episodes, micturition volume and OABSS score. An increased post-void residual urine volume, dysuria, and urinary tract infection represented adverse events (AEs) in the Hengli® BTX-A group. Most AEs were mild or moderate in severity. One patient in the BTX-A group initiated clean intermittent catheterization (CIC) during treatment. Conclusion: Hengli® BTX-A treatment was well-tolerated and resulted in significant improvements in OAB symptoms among Chinese patients inadequately managed by anticholinergics. Clinical Trial Registration: http://www.chinadrugtrials.org.cn/clinicaltrials.prosearch.dhtml, Identifier: CTR20131190.

Efficacy and safety of moxibustion in the treatment of female stress urinary incontinence: A protocol for systematic review and meta-analysis.

Background:Stress urinary incontinence (SUI) is one of the common diseases in female urinary system diseases, and the incidence is increasing year by year. Moxibustion therapy, as a kind of acupuncture therapy, has been widely used in the clinical treatment of SUI, but its therapeutic effect and safety have not been scientifically and systematically evaluated. Therefore, the protocol of this systematic review we propose this time is to scientifically evaluate the effectiveness and safety of moxibustion in the treatment of female stress urinary incontinence (FSUI).Methods:The following 8 electronic databases will be searched from establishment to December 2021: PubMed, Web of Science, Cochrane Library, Embase, China National Knowledge Infrastructure, VIP Database, Wanfang Database, China Biology Medicine disc. All randomized controlled trials of moxibustion in the treatment of FSUI will be searched in the above electronic databases. Two reviewers will independently complete research selection, data extraction, and research quality evaluation. After screening the studies, the quality of the included studies will be evaluated according to the quality standards specified in the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0). The primary outcome of included studies is the change from baseline in urine leakage measured by the 1-hour pad test. Secondary outcomes include: the short-form of the International Consultation on Incontinence Questionnaire, the mean 72-hour urinary incontinence episode frequency, self-assessment of the patient's treatment effect, severity of urinary incontinence, and adverse events. Two reviewers will independently conduct study selection, data extraction, risk of bias assessment, and study quality assessment. And the STATA 14.0 software will be implemented for data synthesis and meta-analysis.Results:The result of this meta-analysis will be submitted to peer-reviewed journals for publication, and a comprehensive review of current evidence will be conducted.Conclusions:The conclusion of this systematic review will provide evidence for judging whether moxibustion is a safer and more effective intervention for female stress urinary incontinence.Trial registration number:The protocol has been registered on INPLASY2021120052.

A Randomized Pilot Study to Compare the Effectiveness of a Low FODMAP Diet vs Psyllium in Patients With Fecal Incontinence and Loose Stools.

INTRODUCTION:The aim of the study was to compare the effectiveness of a low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol diet (LFD) vs psyllium on the frequency and severity of fecal incontinence (FI) episodes in patients with loose stools.METHODS:This was a single-center, randomized pilot trial of adult patients with FI (Rome III) with at least 1 weekly FI episode associated with loose stool. Eligible patients were randomized to 4 weeks of either a dietitian-led LFD or 6 g/d psyllium treatment.RESULTS:Forty-three subjects were randomized from October 2014 to May 2019. Thirty-seven patients completed the study (19 LFD and 18 psyllium). There was no statistically significant difference in the proportion of treatment responders (>50% reduction in FI episodes compared with baseline) for treatment weeks 1–4 (LFD 38.9%, psyllium 50%, P = .33). Compared with baseline, mean fecal incontinence severity index score significantly improved with LFD (39.4 vs 32.6, P = .02) but not with psyllium (35.4 vs 32.1, P = .29). Compared with baseline values, the LFD group reported improvements in fecal incontinence quality of life coping/behavior, depression/self-perception, and embarrassment subscales. The psyllium group reported improvement in incontinence quality of life coping/behavior.DISCUSSION:In this pilot study, there was no difference in the proportion of patients who reported a 50% reduction of FI episodes with the LFD or psyllium. Subjects in the psyllium group reported a greater reduction in overall FI episodes, whereas the LFD group reported consistent improvements in FI severity and quality of life. Further work to understand these apparently discrepant results are warranted but the LFD and psyllium seem to provide viable treatment options for patients with FI and loose stools.

Acupuncture for prostatectomy incontinence: study protocol for a multicenter single-blind randomized parallel controlled trial

BackgroundUrinary incontinence is a common complication post radical prostatectomy. Acupuncture is considered an effective treatment for post-prostatectomy incontinence (PPI), but the evidence is still limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial.MethodsTwenty hospitals will recruit 340 participants with urinary incontinence after radical prostatectomy in China from April 2021 to April 2022. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The study plan consists of 1-week baseline, 6-week treatment, and 18-week follow-up. Eighteen 30-min sessions of acupuncture or sham acupuncture treatment will be provided between weeks 1 and 6. The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score at the week 6 from the baseline. Secondary outcomes include the change in volume of urine leakage at weeks 4 and 6 from a baseline measured using the 1-h pad test; 72-h incontinence episode frequency based on a 72-h voiding diary; change in the Expanded prostate cancer Index Composite scale (EPIC-26); change in the Self-Rating Anxiety Scale; weekly consumption of pads; and the severity of urinary incontinence based on a 72-h bladder diary and self-assessment of the therapeutic effect. The safety of acupuncture will also be assessed.DiscussionThis trial will help to identify whether acupuncture is effective for PPI, and, if so, whether it exerts a therapeutic rather than a placebo effect.Trial Registrationwww.Chictr.org.cnChiCTR2100042500. Retrospectively registered on 22 January 2021.

Efficacy of intravaginal electrical stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial.

ABSTRACTPurpose:To evaluate the efficacy of intravaginal electrical stimulation (IVES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB).Materials and Methods:Sixty-two women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n:31), and Group 2 received BT+IVES (n:31). IVES was performed for twenty minutes three days a week over a course of eight weeks for a total of 24 sessions. Patients were evaluated in terms of incontinence severity (24-hour pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes and number of pads), symptom severity (OAB-V8), incontinence-related QoL (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale).Results:A statistically significant improvement was found in all parameters for all groups at the end of the treatment compared to the baseline values except pelvic floor muscles strength in Group 1 (p <0.05). At the end of treatment, incontinence severity, frequency of voiding, nocturia, incontinence episodes, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p <0.05). Treatment satisfaction, cure/improvement, and positive response rates were significantly higher in group 2 compared to Group 1 (p <0.05).Conclusion:We conclude that BT+IVES were more effective than BT alone on both incontinence-related QoL and clinical parameters in women with idiopathic OAB.

Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial

BackgroundDifferent studies have reported the efficacy of percutaneous tibial nerve stimulation (PTNS) and transcutaneous tibial nerve stimulation (TTNS) in treating idiopathic overactive bladder (OAB). However, no study has compared the effectiveness of PTNS and TTNS added to bladder training (BT) in idiopathic OAB. ObjectiveTo compare the efficacy of PTNS and TTNS added to BT in women with idiopathic OAB. MethodsWe randomised 60 women with idiopathic OAB into 3 groups. Group 1 (n=19) received BT, Group 2 (n=19) received PTNS in addition to BT, and Group 3 (n=20) received TTNS in addition to BT. PTNS and TTNS were performed 2 days a week, for 30min a day, for a total of 12 sessions for 6 weeks. Patients were evaluated by incontinence severity (pad test), a 3-day voiding diary (frequency of voiding, incontinence episodes, nocturia and number of pads used), symptom severity, quality of life, treatment success (positive response rate), treatment satisfaction (Likert scale), discomfort level and preparation time for stimulation (sec). ResultsAt the end of treatment; severity of incontinence, frequency of voiding, incontinence episodes, nocturia, number of pads used, symptom severity and quality of life were significantly improved in Groups 2 and 3 versus Group 1 (P<0.0167). Treatment success and treatment satisfaction were higher in Groups 2 and 3 than Group 1 (P<0.001 and P<0.0167, respectively). Level of discomfort was lower, treatment satisfaction was higher and preparation time for stimulation was shorter in Group 3 than Group 2 (P<0.05). ConclusionBoth the PTNS plus BT and TTNS plus BT were more effective than BT alone in women with idiopathic OAB. These 2 tibial nerve stimulation methods had similar clinical efficacy but with slight differences: TTNS had shorter preparation time, less discomfort level and higher patient satisfaction than PTNS.

English

BACKGROUND Overactive bladder (OAB) is a chronic, age-related disorder seen in 11 % of patients. Symptoms consist of urinary urgency, with or without urinary incontinence, usually with frequency or nocturia. The objective of the present study was to compare the efficacy and side effects of mirabegron and solifenacin as primary therapies in patients with overactive bladder. METHODS This was a prospective interventional study. 100 patients aged between 18 years and 50 years with overactive bladder were included and were assigned into two treatment groups of solifenacin 5 mg or mirabegron 50 mg. They were asked to record the number of micturitions in a day, urgency episodes, incontinence episodes and volume of each micturition. All patients went through a basic workup with blood sugar to rule out diabetes, USG KUB to rule out bladder stones, and urine culture and sensitivity to rule out urinary tract infection (UTI). RESULTS 100 patients with OAB were selected for the study and divided into equal groups, 50 receiving 5 mg solifenacin and 50 receiving 50 mg mirabegron. Both groups increased the mean micturition volume but mirabegron was more effective in increasing the mean micturition in patients with OAB. Both drugs were well tolerated. There was a significant increase in mean micturition volume in mirabegron 50 mg group (by 20.7 + / - 2.2 mL), P &lt; 0.001 whereas in solifenacin group micturition volume was increased to 22.2 + / -0.97 ml). The most common side-effect in the mirabegron group was hypertension and the most common side effect in the solifenacin group was dry mouth. CONCLUSIONS Both mirabegron and solifenacin were effective in controlling the frequency of micturition, decreasing urgency and incontinence episodes and increasing the mean volume of micturition. Mirabegron was more effective than solifenacin in controlling urgency and incontinence episodes and increasing the mean volume of micturition. KEY WORDS Overactive Bladder (OAB), Micturition, Mirabegron, Solifenacin.

Intravaginal Pulsed Contractile Radiofrequency for Stress Urinary Incontinence Treatment; A Safety Study.

Introduction: Radiofrequency (RF)-based stress urinary incontinence (SUI) treatment, which has quickly attracted attention, is administered in an office setting. This pilot-safety study assessed the efficacy of transvaginal RF treatment in the quality of life (QOL) and frequency of incontinence episodes in women with SUI. Methods: Twenty-eight women suffering from SUI were treated with an intravaginal quadric applicator while a grounding pad was attached in front of their pubes. The first phase is thermic, which will heat up the vaginal wall up to 40°C for 10 minutes. The second step is contraction to stimulate an aerobic exercise of pelvic floor muscles for 20 minutes (pulsed contractile RF at 20-40 watts and 1000-300 kHz with a modulation of 1 to 300 Hz for muscle exercise). It was scheduled for one session per week for 3 sessions. Patients had follow-up visits before and 1, 6 and 12 months following the treatment for one-day voiding diary, Persian version of urinary incontinence QOL questionnaire (I-QOL), Q-tip test, 24 hours-pad test and daily incontinence episodes' number. Results: The patients' mean age, duration of incontinence and median vesical leak point pressure were 41.6±9.6 years, 5.48±6.84 years and 140 cm H2 O respectively. Significant changes were observed in the mean I-QOL total score and the pad test. Also, a notable reduction was observed in the number of daily leakage episodes and the Q-tip test at any follow-up visit (P=0.001). Conclusion: Preliminary results suggest that transvaginal RF is a convenient method of SUI treatment. Significant changes were observed in the mean I-QOL total score and the pad test. Also, a notable reduction was observed in the number of daily leakage episodes.

Trigonal-Sparing vs. Trigonal-Involved OnabotulinumtoxinA Injection for the Treatment of Overactive Bladder: A Systematic Review and Meta-Analysis

Objective: Overactive bladder (OAB) is a disease characterized by the presence of urinary urgency. We carried out a meta-analysis to assess the effectiveness and safety of trigonal-involved injection of onabotulinumtoxinA (BoNT-A) in comparison with the trigonal-sparing technique in cases with OAB [neurogenic detrusor overactivity (NDO) and idiopathic detrusor overactivity (IDO)].Methods: Randomized controlled trials (RCTs) of BoNT-A injection for OAB were searched systematically by using EMBASE, MEDLINE, and the Cochrane Controlled Trials Register. The datum was calculated by RevMan version 5.3.0. The original references of relating articles were also reviewed.Results: In total, six RCTs involving 437 patients were included in our analysis. For OAB, the trigone-including group showed a different patient symptom score (p = 0.03), complete dryness rate (p = 0.002), frequency of incontinence episodes (p = 0.01), detrusor pressure at maximum flow rate (p = 0.01), and volume at the first desire to void (p = 0.0004) compared with the trigone-sparing group. Also, a trigone-including intradetrusor injection demonstrated a significant improvement in the patient symptom score (p = 0.0004), complete dryness rate (p = 0.0002), frequency of incontinence episodes (p = 0.0003), detrusor pressure at maximum flow rate (p = 0.01), and volume at the first desire to void (p = 0.00006) compared with the trigone-sparing group for treatment of NDO. The adverse events rates were similar in both groups.Conclusions: The meta-analysis has demonstrated that trigone-including BoNT-A injection was more effective compared with the trigone-sparing injection for the treatment of OAB, especially for NDO.

The effect of skeletal muscle-derived cells implantation on stress urinary incontinence and functional urethral properties in female patients.

To evaluate improvement of stress urinary incontinence (SUI) and functional status of the urethra after autologous skeletal-muscle derived cell (aSMDC) implantation. Phase I-II, open, non-randomized, single-center study of ultrasound guided aSMDC implantation (dosed at 0.2×106 cells/2mL) into the external urethral sphincter to treat SUI. A total of 38 patients were treated and followed for 2years. SUI measured by Incontinence Episode Frequency score, short pad test, quality of life, patient's and clinician's perception significantly improved and remained improved after 2years. However, urodynamic urethral properties in general did not improve at 1-year after treatment. Subgroup analysis revealed that addition of an adjuvant functional electrical stimulation therapy discontinued 4weeks after injection in the compliant group, gave better urodynamic values and maintained the long-term SUI improvement at 2years. The aSMDC injection was safe and well-tolerated by patients. The status of SUI improved and with it the quality of life of patients, even if this was not necessarily reflected in the urodynamic urethral properties. Electrical stimulation, as an adjuvant therapy, could have an essential role in the success of the therapy. Clinical study was registered under Eudra-CT number: 2010-021867-34 at European Clinical Trial Database (EudraCT), accessible at: EudraCT (europa.eu).