Five-year Results from the Prospective, Multicenter, Observational SOUNDS Study of Patients with Overactive Bladder Treated with the InterStim System for Sacral Neuromodulation.

BACKGROUND: Although sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice. OBJECTIVE: To report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up. DESIGN, SETTING, AND PARTICIPANTS: A total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo. RESULTS AND LIMITATIONS: The mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale-based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients. CONCLUSIONS: SOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature. PATIENT SUMMARY: This study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.

Twelve-month Durability of a Fully-implanted, Nickel-sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence: A Single-Arm, Prospective Study.

OBJECTIVES: To evaluate the safety and efficacy of the eCoin - a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS: A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS: Responders were defined as those who had a ≥50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION: The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns.

Urinary and fecal incontinence in patients with advanced ovarian cancer treated with CRS + HIPEC.

PURPOSE: The objective of this work was to analyze the long-term prevalence of urinary and fecal incontinence and their impact on quality of life in patients with advanced and recurrent ovarian cancer treated with cytoreductive surgery and hyperthermic intraoperative intraperitoneal chemotherapy (CRS + HIPEC). METHODS: This cross-sectional study included a series of patients with advanced and recurrent ovarian cancer treated by CRS + HIPEC, with a disease-free period of at least 12 months after the procedure. Urinary incontinence was evaluated using the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), fecal incontinence using the Wexner test and the Fecal Incontinence Quality of Life (FIQL) questionnaire and global quality of life using the Short Form 36 (SF-36) survey. RESULTS: A total of 64 patients were included in the study, with a median age of 55 years (range 28-78). The urinary incontinence rate was 45% and the fecal incontinence rate was 20%. Up to 14% of the patients presented both types of incontinence. The presence of urinary or fecal incontinence generated a significant negative impact on quality of life in relation to patients without incontinence. DISCUSSION: Urinary and fecal incontinence is frequent in the follow-up of ovarian cancer patients treated with CRS + HIPEC. Reconsidering the approach to the pelvis without peritoneal metastases in the peritoneum could modify the incidence of these pelvic floor dysfunctions.

Sacral Neuromodulation with the InterStim™ System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study.

BACKGROUND: Real-world data that support the use of sacral neuromodulation (SNM) for lower urinary tract dysfunctions are of continued interest. OBJECTIVE: To evaluate the effectiveness, quality of life (QoL), patient-reported outcomes (PROs), and safety of SNM with the InterStim™ system in real life during 1-yr postimplant. DESIGN, SETTING, AND PARTICIPANTS: This is a prospective, multicenter, observational study at 25 representative public and private French sites. Eligible patients received SNM therapy for overactive bladder (OAB) and non-obstructive urinary retention based on local standard of care. Overall, 320 patients were enrolled; 247 received permanent implant or replacement; 204 implanted patients completed second follow-up after mean of 10.0±3.8 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Effectiveness outcomes were change in voids, leaks, and catheterizations/day. Other outcomes included validated QoL and disease severity scores as well as PROs and adverse event data. Outcomes at follow-ups were compared with baseline using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Voids in urinary frequency (UF) and leaks/day in urinary urge incontinence (UI) patients were significantly reduced after 10 mo in both de novo (mean baseline voids/day UF de novo: 12.7 vs 8.6 after 10 mo; p<0.001; mean baseline leaks/day UI de novo: 4.3 vs 1.1 after 10 mo; p<0.001) and replacement patients (mean baseline voids/day UF replacement: 11.5 vs 7.9 after 10 mo; p<0.001; mean baseline leaks/day UI replacement: 5.4 vs 1.0 after 10 mo; p<0.001). Disease bother, Urinary Symptom Profile score, and Ditrovie questionnaire score were also significantly improved. Revisions postimplant occurred in 20% of patients including in 9% due to permanent explantation during a mean exposure time of 24.3 mo. CONCLUSIONS: Through a real-life study, SOUNDS (Sacral neuromOdUlation with InterStim™ therapy for intractable lower uriNary tract DySfunctions) confirms the clinical effectiveness, safety, and positive effect of SNM on QoL and PROs for the treatment of OAB patients. PATIENT SUMMARY: These analyses on French patients who received sacral neuromodulation (SNM) for retention or OAB during a 10-mo period showed that SNM improved OAB symptoms, quality of life, and reduced disease bother. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02186041.

Different electrode positioning for transcutaneous electrical nerve stimulation in the treatment of urgency in women: a study protocol for a randomized controlled clinical trial.

BACKGROUND: Urgency is a complaint of sudden, compelling desire to pass urine, which is difficult to defer, caused by involuntary contraction of the detrusor muscle during the bladder-filling stage. To enable detrusor inhibition, electrotherapy resources such as transcutaneous tibial nerve stimulation (TTNS) and parasacral transcutaneous electrical stimulation (PTES) have been used. The objective this study is to publish the study protocol that aims to investigate whether urgency decreases after treatment with both of the techniques. METHODS: This randomized controlled clinical trial will include 99 women, aged more than 18 years old, with urgency (score ≥ 8 in the Overactive Bladder-Validated 8-Question Awareness Tool [OAB-V8]). Women will be randomly allocated into three groups: TTNS, PTES, and placebo. The following questionnaires will be applied: the Anamnesis Record, the Incontinence Questionnaire Overactive Bladder, the King's Health Questionnaire, the 24-Hour Voiding Diary, and the OAB-V8, at four different time points: at baseline prior to the first session, at the 6th session, the 12th session and at follow-up. The current used for the transcutaneous electrical stimulation will be a symmetrical balanced biphasic pulsed current, for 12 sessions, twice a week, for 20 minutes. Qualitative variables will be displayed as frequency and percentage, quantitative variables as mean and standard deviation. Comparison of urgency severity among groups will be performed with a repeated measures ANOVA, considering the effect of the three groups and the four evaluations, and interactions among them. DISCUSSION: The present study aims to contribute evidence for a more in-depth discussion on electrode positioning for electrostimulation used in urgency treatment. It should be emphasized that, based on the possibility of confirming the hypothesis that urgency will decrease in a similar way after both treatments (TTNS and PTES), the PTES will be used as an option for positioning the electrodes alternatively to the tibial nerve region in special populations, such as amputees or people with severe lower limb sensory impairment. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-9rf33n, date of registration: 17 May 2018.

Urinary tract infection and drug-resistant urinary tract infection after intradetrusor onabotulinumtoxinA injection versus sacral neuromodulation.

INTRODUCTION AND HYPOTHESIS: Intradetrusor onabotulinumtoxinA (BTX) and sacral neuromodulation (SNM) are effective treatments for refractory urgency urinary incontinence/overactive bladder (UUI/OAB). BTX carries a risk of urinary tract infection (UTI), which is concerning for the development of multidrug resistant (MDR) UTI. We hypothesized that BTX might carry a higher risk of UTI and MDR UTI compared with SNM and that UTI and MDR UTI risk might increase after repeat BTX injection. METHODS: This retrospective cohort study included women undergoing BTX or SNM for refractory UUI/OAB in 2012-2016. UTI and MDR UTI were assessed up to 1 year post-treatment or until repeat treatment and compared between initial BTX and SNM and between repeat BTX injections. Univariate analyses included Chi-squared and Fisher's exact tests and generalized linear models (GLM) with logit link function. Multivariate analyses used GLM to assess the best predictor variables for any UTI. RESULTS: One hundred and one patients were included (28 BTX, 73 SNM). Rates of UTI (39.3% [95% CI 21.5, 59.4] BTX vs 37.0% [95% CI 26.0, 49.1] SNM) were similar in the two groups at all time intervals. One MDR UTI occurred after SNM. Risk of UTI did not increase with repeat BTX (11 out of 28 [39.3%], 6 out of 17 [35.3%], and 4 out of 7 [57.1%] after 1, 2, and ≥ 3 treatments respectively; p = 0.62). Multivariate analysis found that history of recurrent UTI (OR 2.5, 95%CI 0.98-6.39) and prolapse repair (OR 4.6, 95%CI 1.23-17.07) had increased odds of UTI. CONCLUSIONS: Rates of UTI were similar in patients undergoing BTX and SNM. MDR UTI was rare. Patients with prior prolapse repair or recurrent UTI may be at a higher risk of UTI after either procedure.

Beyond the bladder: poor sleep in women with overactive bladder syndrome.

BACKGROUND: Nocturnal bladder symptoms and sleep disruption commonly coexist in middle-aged and older women. Although sleep disruption is often attributed to nocturnal bladder symptoms in women with overactive bladder syndrome, nonbladder factors also may influence sleep in this population. Many women with overactive bladder are eager to identify nonpharmacologic strategies for both bladder symptoms and sleep disruption, given the potential adverse effects of sedative and anticholinergic bladder medications in this population. OBJECTIVES: To provide greater insight into the complex relationship between nighttime overactive bladder symptoms and sleep disruption, and to evaluate the effects of a guided slow-paced respiration intervention on sleep outcomes in women with overactive bladder. STUDY DESIGN: We conducted an ancillary study within a randomized trial of slow-paced respiration in women with overactive bladder symptoms. Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence were randomized to use either a portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing (N=82). At baseline and after 12 weeks, bladder symptoms were assessed by voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality was determined by a Pittsburgh Sleep Quality Index global score >5. RESULTS: Of the 161 women randomized, 31% reported at least twice-nightly nocturia, 26% nocturnal incontinence, and 70% poor sleep quality at baseline. Of the 123 reporting any nighttime awakenings, 89% averaged 1 or more nighttime awakenings, and 83% attributed at least half of awakenings to using the bathroom. Self-reported wake time after sleep onset increased with increasing frequency of nocturnal bladder symptoms (P=.01 for linear trend). However, even among women without nocturia, average sleep quality was poor (Pittsburg Sleep Quality Index global score mean of 7.3; 95% confidence interval, 6.0-8.6). Over 12 weeks, women assigned to slow-paced respiration (N=79) experienced modest improvements in mean nocturnal voiding frequency (0.4 fewer voids/night), sleep quality (1.1 point score decrease), and sleep disruption (1.5% decreased wake time after sleep onset). However, similar improvements were detected in the music control group (N=81), without significant between-group differences. CONCLUSIONS: Many women with overactive bladder syndrome experience disrupted sleep, but not all nocturnal awakenings are attributable to bladder symptoms, and average sleep quality tends to be poor even in women without nocturia. Findings suggest that clinicians should not assume that poor sleep in women with overactive bladder syndrome is primarily caused by nocturnal bladder symptoms. Guided slow-paced respiration was associated with modest improvements in nocturia frequency and sleep quality in this trial, but the results do not support clinician recommendation to use this technique over other behavioral relaxation techniques for improving sleep.

Comparison of Multipulse Laser Vaporesection versus Plasmakinetic Resection for Treatment of Benign Prostate Obstruction.

We aimed to compare the efficacy and safety of Multipulse laser vaporesection of the prostate (MPVP) versus plasmakinetic resection of the prostate (PKRP) for treatment of patients with benign prostate obstruction (BPO) in a prospective trial. From January 2016 to April 2017, a total of 144 patients were included in the cohort study, of whom 73 patients underwent MPVP and 71 underwent PKRP. All patients received pre-operative evaluation and followed up at 1, 3, 6 and 12 months postoperatively. Baseline characteristics, perioperative data and postoperative outcomes were compared. Early (within 30 days postoperatively) and late complications were also recorded. Preoperative data, including age, prostate volume, international prostate symptom score (IPSS), International Index of Erectile Function Questionnaires (IIEF-5), the rate of anticoagulants use, Charlson comorbidity index were similar in two groups. Peri-operative parameters, including the rate of transfusion, and decrease in hemoglobin level were comparable. The operative time, the duration of catheterization and length of hospital stay were significantly shorter in the MPVP group. The voiding parameters and the quality-of-life scores (QoL) improved significantly in both groups postoperatively. There was a significantly difference in QoL at 1-year in the MPVP group (p < 0.001), under mixed model analysis with random effect and Bonferroni correction. There were no significant differences in improvement of IPSS, Qmax, IIEF-5, residual prostate volume ratio and PSA level reduction at the 1-year follow-up. MPVP was significantly superior to PKRP in terms of a reduction in overall complication rate (21.9% vs 45.0%, p = 0.004). Both treatments led to comparable symptomatic improvements. MPVP demonstrates satisfactory efficiency, shorter catheterization time and shorter hospital stay. Our data revealed that MPVP may be a promising technique which is safe and favorable alternative for patients with BPO.

Evaluation of pain and catheter-related bladder discomfort relative to balloon volumes of indwelling urinary catheters: A prospective study.

PURPOSE: To evaluate patients' tolerance to indwelling urinary catheters (IUCs) before and after reducing their balloon volumes. IUCs are a source of discomfort or pain. MATERIALS AND METHODS: All consecutive patients hospitalized in our department with IUCs were included during the study period with some exclusion. Each patient was his/her own control before and two hours after reduction of the balloon volume (RBV) by half using two types of assessments, a visual analog scale for pain and a catheter-related bladder discomfort (CRBD) symptom questionnaire. RESULTS: Forty-nine patients were included in our study that completed the assessments. The mean scores for pain before and after RBVs were 2.80 and 2.02, respectively. The difference was significant (p<0.05). The mean grades of the CRBD before and after RBVs were 1.02 and 0.75, respectively. The difference was significant (p<0.05). CONCLUSIONS: A 50% RBV has shown a significant amelioration in tolerating the catheter.

Comparing Vitamin D Supplementation Versus Placebo for Urgency Urinary Incontinence: A Pilot Study.

OBJECTIVES: To estimate the efficacy of vitamin D supplementation to reduce urgency urinary incontinence (UUI) episodes. DESIGN: Pilot, two-arm, randomized trial conducted from 2013 to 2017. Interventions were 12 weeks of weekly oral 50,000 IU vitamin D3 or placebo. SETTING: Academic, university-based outpatient clinic. PARTICIPANTS: Community-dwelling postmenopausal women, 50 years or older, with at least three UUI episodes on 7-day bladder diary and serum vitamin 25-hydroxyvitamin D (25[OH]D) of 30 ng/mL or less. MEASUREMENTS: The primary efficacy estimate was the percentage change in UUI episodes. Secondary estimates included changes in other lower urinary tract symptoms, along with exploratory subgroup analysis by race/ethnicity and obesity. RESULTS: We randomized 56 women (aged 50-84 years; mean = 60.5 ± 8.2 years), 28 to vitamin D and 28 to placebo; 51 completed treatments. Mean serum 25(OH)D at baseline (21.2 ± 5.2 and 18.2 ± 5.6, P = .30) improved to 57.9 ± 16.3 ng/mL with vitamin D3 and 21.9 ± 8.2 ng/mL with placebo (P < .001). UUI episodes per 24-hour day decreased by 43.0% with vitamin D3 compared to 27.6% with placebo (P = .22). Among black women (n = 33), UUI episodes decreased by 63.2% with vitamin D3 compared to 22.9% with placebo (P = .03). Among obese women, UUI episodes decreased by 54.1% with vitamin D compared to 32.7% with placebo (P = .29). For all women, changes in voiding frequency (P = .40), nocturia (P = .40), urgency (P = .90), incontinence severity (P = .81), and overactive bladder symptom severity (P = .47) were not different between arms. CONCLUSIONS: Postmenopausal women with UUI and vitamin D insufficiency demonstrated a greater than 40% decrease in UUI episodes, which did not reach statistical significance compared to placebo, except in the subset of black women. The results of this pilot study support further investigation of vitamin D3 alone or in combination with other treatments for UUI, particularly for women in higher-risk subgroups. J Am Geriatr Soc 67:570-575, 2019.

Audiovisual stimulus during urodynamics to provoke detrusor overactivity: A randomized trial.

OBJECTIVE: This study estimated the effect of adding an audiovisual (AV) intervention during urodynamic evaluation (UDE) on increasing detrusor contractions (DO) versus routine UDE testing without AV cues. METHODS: A randomized trial was conducted of women with overactive bladder (OAB) undergoing UDE with and without AV intervention. The AV intervention was a 1-minute video on continuous loop showing common OAB triggers. A continuous running waterfall provided auditory stimulation. The primary outcome was the proportion of patients who had DO on UDE, interpreted by masked clinicians. Secondary outcomes included the number, amplitude, and duration of DO and urinary leakage associated with DO. A sample size of 109 per group was calculated to have 80% power to detect a 20% difference with a significance level of 0.05. RESULTS: In all, 109 women each were randomized to standard UDE and to the AV intervention. There was no difference in the proportion of patients with DO on UDE between the intervention and control groups (35% vs 32%, respectively; P = 0.8). Furthermore, there were no differences between the intervention and control groups in leakage with DO on UDE (24% vs 21%, respectively), mean duration of detrusor contractions (23.9 vs 25.3 s, respectively), or mean maximum detrusor pressure during involuntary contractions (18.1 vs 20.6 cm H2 O, respectively). Clinical severity of OAB symptoms was not associated with the detection of DO or other UDE parameters. CONCLUSIONS: Addition of AV intervention during UDE did not increase the finding of detrusor contractions. The relationship between OAB triggers, urge incontinence, and urodynamic findings remains unclear.

Specific Changes in Brain Activity during Urgency in Women with Overactive Bladder after Successful Sacral Neuromodulation: A Functional Magnetic Resonance Imaging Study.

PURPOSE: The mechanism of sacral neuromodulation is poorly understood. We compared brain activity during urgency before and after sacral neuromodulation in women with overactive bladder and according to the response to treatment. MATERIALS AND METHODS: Women with refractory overactive bladder who elected sacral neuromodulation were invited to undergo functional magnetic resonance imaging before and after treatment. During imaging the bladder was filled until urgency was experienced. Regions of interest were identified a priori and brain activity in these regions of interest was compared before and after treatment as well as according to the treatment response. Whole brain exploratory analysis with an uncorrected voxel level threshold of p <0.001 was also performed to identify additional brain regions which changed after sacral neuromodulation. RESULTS: Of the 12 women who underwent a pretreatment functional magnetic resonance imaging examination 7 were successfully treated with sacral neuromodulation and underwent a posttreatment examination. After sacral neuromodulation brain activity decreased in the left anterior cingulate cortex, the bilateral insula, the left dorsolateral prefrontal cortex and the bilateral orbitofrontal cortex (each p <0.05). No new brain regions showed increased activity after sacral neuromodulation. Pretreatment brain activity levels in the bilateral anterior cingulate cortex, the right insula, the bilateral dorsolateral prefrontal cortex, the right orbitofrontal cortex, the right supplementary motor area and the right sensorimotor cortex were higher in women who underwent successful treatment (each p <0.05). CONCLUSIONS: Brain activity during urgency changes after successful sacral neuromodulation. Sacral neuromodulation may be more effective in women with higher levels of pretreatment brain activity during urgency.

Does sex matter? A matched pairs analysis of neuromodulation outcomes in women and men.

AIMS: To evaluate whether baseline symptoms and outcomes are influenced by gender in a matched cohort undergoing neuromodulation. METHODS: Patients in our prospective neuromodulation database that had a tined lead placed were reviewed. Those that had implantable pulse generator (IPG) placed were matched on age and urologic diagnosis. History, voiding diaries, satisfaction, Interstitial Cystitis Symptom/Problem Index (ICSIPI), and overactive bladder symptom severity (OABq ss)/health-related quality of life (HRQOL) preimplant and over 3 years were evaluated using descriptive statistics, repeated measures, and matched pair GEE or mixed analyses. RESULTS: Of 590 patients in the database, more women than men received an IPG (450/488; 92.2 vs. 84/102; 82.4%; p = 0.0011). Eighty matched pairs (n = 160; 81% ≥ 50 years old; 56.25% had urgency/frequency with urge incontinence-UI) were identified and evaluated. On voiding diaries, volume/void was greater in women only at baseline (p = 0.040); both groups improved over time (p < 0.0001). Urinary frequency improved in both women and men (p = 0.0010; p = 0.0025). Over 3 years, UI episodes/day improved only in men (p = 0.017) and UI severity improved only in women (p < 0.0001). ICSIPI, OABq ss, and HRQOL scores improved similarly in both groups (p < 0.0001 for all measures in both groups), and although more women were satisfied at 3 months (p = 0.027), groups did not differ at other time points. CONCLUSIONS: More women undergo neuromodulation and have initial success and subsequent IPG implantation. UI episodes improved only in men, and UI severity improved only in women. Both women and men experienced similar levels of symptom improvement on other measures.

Transcutaneous stimulation of the posterior tibial nerve for treating refractory urge incontinence of idiopathic and neurogenic origin. / Estimulación transcutánea del nervio tibial posterior en el tratamiento de la incontinencia urinaria de urgencia refractaria, de origen idiopático y neurógenico.

OBJECTIVE: To assess the efficacy of treatment with transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with urge urinary incontinence, of neurogenic or nonneurogenic origin, refractory to first-line therapeutic options. MATERIAL AND METHODS: We included 65 patients with urge urinary incontinence refractory to medical treatment. A case history review, a urodynamic study and a somatosensory evoked potentials (SEP) study were conducted before the TPTNS, studying the functional urological condition by means of a voiding diary. The treatment consisted of 10 weekly sessions of TPTNS lasting 30minutes. RESULTS: Some 57.7% of the patients showed abnormal tibial SEPs, and 42% showed abnormal pudendal SEPs. A statistically significant symptomatic improvement was observed in all clinical parameters after treatment with TPTNS, and 66% of the patients showed an overall improvement, regardless of sex, the presence of underlying neurological disorders, detrusor hyperactivity in the urodynamic study or SEP disorders. There were no adverse effects during the treatment. CONCLUSIONS: TPTNS is an effective and well tolerated treatment in patients with urge incontinence refractory to first-line therapies and should be offered early in the treatment strategy. New studies are needed to identify the optimal parameters of stimulation, the most effective treatment protocols and long-term efficacy, as well as its applicability to patients with a neurogenic substrate.

Outcomes of Sacral Neuromodulation in Patients with Prior Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse.

OBJECTIVES: The aim of this study was to evaluate the efficacy of sacral neuromodulation in patients with prior stress urinary incontinence (SUI) or pelvic organ prolapse (POP) surgery. METHODS: Women in our prospective neuromodulation database were evaluated. Patients with a history of prior SUI/POP surgery were compared to those without. Medical records at baseline were reviewed, and primary outcome was defined as moderate/marked improvement on Global Response Assessment (GRA) at 3 months. Secondary outcomes were measured using bladder diaries and Overactive Bladder Symptom Severity (OABq-SS)/health-related quality of life (HRQOL). Data were analyzed with Pearson χ test, Fisher exact test, Wilcoxon rank-sum test, and repeated-measures analyses. RESULTS: Of 210 subjects, 108 (51%) had prior SUI/POP surgery. Patients with SUI/POP surgery had more prior hysterectomies. At 3 months, there was no difference between groups on GRA outcomes. On the bladder diary, both groups had improvement in median voids per 24 hours, urgency severity, and urge incontinence over 2 years. On the GRA, fewer patients in the SUI/POP group were treatment responders at 12 and 24 months. For urinary urgency, a few in this group were moderately/markedly improved at 6 months, and a higher proportion are reported still leaking urine at 6 and 12 months. Similar proportions in each group reported moderate/marked improvement in leaking. Satisfaction was similar between groups. The OABq-SS/HRQOL scores improved, and there was no difference between the groups. CONCLUSION: Sacral neuromodulation improves bladder symptoms in women with prior SUI/POP surgery, but response may be slightly less in those with prior surgery due to underlying bladder or pelvic floor issues.

Comparison between thulium laser resection of prostate and transurethral plasmakinetic resection of prostate or transurethral resection of prostate.

Benign prostatic hyperplasia (BPH) is one of the most common diseases in middle-aged and elderly men. In the present study, we aimed to compare the efficacy and safety of thulium laser resection of the prostate (TMLRP) with either transurethral plasmakinetic resection of the prostate (TUPKP) or transurethral resection of the prostate (TURP). A literature search was performed, eventually, 14 studies involving 1587 patients were included. Forest plots were produced by using Revman 5.2.0 software. Our meta-analysis showed that operation time, decrease in hemoglobin level, length of hospital stay, catheterization time, and development of urethral stricture significantly differed, whereas the transitory urge incontinence rate, urinary tract infection rate, and recatheterization rate did not significantly differ between TMLRP and either TURP or TUPKP. The blood transfusion rate was significantly different between TMLRP and TURP, but not between TMLRP and TUPKP. In addition, the retrograde ejaculation rate between TMLRP and TURP did not significantly differ. At 1, 3, 6, and 12 months of postoperative follow-up, the maximum flow rate, post-void residual, quality of life, and International Prostate Symptom Score did not significantly differ among the procedures. Thus, the findings of this study indicate that TMLRP may be a safe and feasible alternative.

Percutaneous tibial nerve stimulation versus tolterodine for overactive bladder in women: a randomised controlled trial.

OBJECTIVE: We performed a randomised controlled trial of percutaneous tibial nerve stimulation (PTNS) versus tolterodine for treating treatment naïve women with overactive bladder (OAB). STUDY DESIGN: 36 patients with symptoms of OAB were randomised to 3 months of treatment with weekly PTNS or tolterodine (2mg bid p.o.). The primary outcome measure was the difference of micturitions per 24h. The secondary outcome measure was the impact on quality of life (QoL) measured with a visual analogue scale (VAS) between baseline and after 3 months of therapy. RESULTS: Micturition frequencies did not decline significantly (p=0.13) over time and there were no significant treatment differences (p=0.96). QoL was significantly dependent from its level at baseline (p=0.002) and showed improvement over time compared to baseline measurements but no significant differences between both treatment groups (p=0.07). Incontinence episodes per 24h depended significantly on the level at baseline (p=0.0001) and declined significantly (p=0.03) during 3 months of therapy in both therapy groups. However no significant treatment differences on the reduction of incontinence episodes in 24h could be shown between both therapy groups (p=0.89). PTNS had fewer side effects than tolterodine (p=0.04). CONCLUSION: PTNS and tolterodine were both effective in reducing incontinence episodes and improving QoL in patients with OAB but not micturition frequencies. PTNS had fewer side effects.

Central inhibition of refractory overactive bladder complaints, results of an inpatient training program.

SHORT INTRODUCTION: Overactive bladder (OAB) in children has an overall reported incidence of 16.6-17.8%, with its prevalence of 0.2-9% varying largely between age and gender. OAB is the most important burden in pediatric urology because of the limited effect of treatment. OAB with imperative urge and/or urge incontinence can often be successfully treated with urotherapy and pharmacological treatment. Nevertheless, approximately 20% of patients are considered to be therapy resistant for common treatment options. For the latter group, an inpatient cognitive and biofeedback training program for children has been developed. OBJECTIVE: Our objective is to evaluate the effect of an inpatient cognitive and biofeedback training program for children with urge complaints and urge incontinence based on overactive bladder (OAB) after failed earlier treatment by anticholinergic medication and by outpatient urotherapy. A search for predictors for success of treatment outcome is included in the study. STUDY DESIGN: Seventy children with therapy refractory incontinence based on OAB went through a 10-day in-hospital training program between 2007 and 2010. The children were aged between 7 and 13 years (mean 9.29 years) and 48 (68.6%) were male. An essential part of this program is teaching the children central inhibition of their bladder to suppress bladder overactivity. Before attending this training program patients had on average 41.1 months of fruitless treatment by urotherapy and medication, and if needed preceding surgery for meatus correction or deobstruction. The training result was evaluated 6 months after completion of the inpatient training program. A questionnaire was subsequently conducted 2 years after the training to evaluate the long-term efficacy of this program. RESULTS: Six months after training, evaluation showed that 30 of the 70 patients (42.9%) were free of complaints, 22 (31.4%) had a significant reduction in complaints and 18 (25.7%) had no improvement. Logistic regression analysis was used to look at several variables predicting training outcome. A higher age during clinical training was found to be a predictor for a good training outcome. After 2 years, 44 (62.9%) patients were reached for long-term follow-up. Of these patients, 28 (63.6%) reported a good effect of the training and 11 (25%) experienced no improvement in symptoms compared with before clinical training. Objectively, 26 (59.1%) were dry and 18 (40.9%) were incontinent to some extent. A total of 30 (68.2%) patients had not relapsed into urge complaints (McNemar's test P-value <0.05). DISCUSSION: Age was found to be a predictor of a good training result, which is in line with the findings of other publications where children above the age of 8 demonstrate better and faster training results. The absolute number of participants to perform statistical analysis on was low, even though it was the number maximally achievable in this cohort, possibly explaining how other variables could not be found to predict training outcome. No differences in outpatient therapy results were observed between patients having received earlier outpatient urotherapy in our hospital when compared with being trained elsewhere. This is coherent with previous research indicating that for outpatient training, the attention offered to the child is of paramount importance. Regarding long-term follow-up, keeping in mind long-term follow-up patient numbers were incomplete, a good effect of the training was seen with a clear reduction in incontinence complaints. Far fewer children are suffering from urge complaints, although some patients had relapsed into urge complaints. CONCLUSION: The inpatient cognitive and biofeedback training program for refractory OAB complaints has been demonstrated to cure or improve 74.3% of patients, and conveyed favorable long-term results in approximately 75.0% of patients. A higher age during clinical training was found to be a predictor for good training outcome.

Efficacy and safety of ginger-salt-indirect moxibustion for urge urinary incontinence after stroke: protocol for a pilot multicentre randomised controlled trial.

INTRODUCTION: Ginger-salt-indirect moxibustion is widely applied to treat urge urinary incontinence after stroke, which is a common complication in stroke survivors. Moxa cone moxibustion and moxa box moxibustion are the main techniques of ginger-salt-indirect moxibustion. Our previous study had shown that ginger-salt-indirect moxibustion using moxa cones was feasible and effective for urination disorders post-stroke. This pilot study aims to assess the feasibility of conducting research to evaluate the efficacy and safety of ginger-salt-indirect moxibustion for patients with post-stroke urge urinary incontinence. METHODS AND ANALYSIS: This is a multicentre, prospective, single-blinded, pilot randomised controlled trial. 120 eligible patients will be randomly allocated to three groups. Treatment group A (n=40) will receive moxa cone moxibustion and routine care; treatment group B (n=40) will receive moxa box moxibustion and routine care; control group (n=40) will only receive routine care for stroke recovery. The entire moxibustion treatment will consist of a total of 28 sessions during the course of 4 weeks. The primary outcome measure will be the increase in mean volume per void assessed at week 4 from the first moxibustion session (baseline). Secondary outcome measures will include mean frequency of urination per day and quality of life assessments measured by completion of the Incontinence Quality of Life Questionnaire and Barthel Index. All outcome measures will be assessed at baseline and at 4 and 16 weeks from baseline. Adverse events in the three groups will be recorded to assess the safety of moxibustion. ETHICS AND DISSEMINATION: Research ethics was approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to the Capital Medical University (ref: 2013BL-094). Written informed consent will be obtained from all participants. Study results will be published in peer reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN 44706974.

Percutaneous tibial nerve stimulation as an off-label treatment of clitoral pain.

OBJECTIVE: Percutaneous tibial nerve stimulation (PTNS) is used to treat refractory urinary frequency, urgency, and urgency urinary incontinence. To date, it is not approved by the US Food and Drug Administration in the treatment of chronic pain syndromes, and its use in the treatment of chronic clitoral pain has not been reported. METHODS: We describe 2 cases of women who presented with symptoms of urgency urinary incontinence, urinary frequency, and clitoral pain. After inadequate response to conservative treatment of their urinary symptoms, they received PTNS. RESULTS: By the 12th session, significant improvement in urinary symptoms and resolution of clitoral pain were noted. CONCLUSIONS: The findings of this report suggest that PTNS may be a therapeutic option in patients with idiopathic clitoral pain.