Does choice of anesthesia during stage 1 sacral neuromodulation testing influence outcomes?

INTRODUCTION: Staged sacral neuromodulation (SNM) testing has been shown to have a high rate of progression to permanent implantation for the management of voiding dysfunction. Stage 1 lead placement (SNM-I) can be performed under monitored anesthesia care (MAC) or general anesthesia (GA). MAC allows for interpretation of sensory and motor responses to optimize lead placement while GA only permits for motor assessment. However, patient discomfort and movement can make lead placement challenging during MAC. Herein we evaluate whether the anesthesia type impacts the progression rate to permanent implantation (SNM-II). MATERIALS AND METHODS: A retrospective chart review was performed for patients who underwent SNM-I in the operating room for wet overactive bladder between 2005 and 2023. Patients were divided into two groups based on the type of anesthesia used, MAC or GA. Clinical variables and progression to SNM-II were compared between cohorts. Progression to SNM-II was based on ≥50% symptomatic improvement during a 1-2 week trial period following SNM-I. RESULTS: Of 121 patients included in the study, 95 (79%) underwent MAC and 26 (21%) GA for SNM-I. No difference in the progression rate to SNM-II was noted between groups (MAC, 68/95 patients, 72%; GA, 19/26, 73%; p = 0.39). We also found no difference when comparing the GA group to the 26 most recent MAC patients (MAC, 20/26 patients, 77%; GA, 19/26, 73%; p = 0.48). CONCLUSION: Types of anesthesia for SNM-I did not affect rate of progression to SNM-II. The result lends support to the reliance on motor responses alone for lead placement during SNM-I.

Use of Fermented Red Clover Isoflavones in the Treatment of Overactive Bladder in Postmenopausal Women: A Randomized, Double-Blinded, Placebo-Controlled Trial.

Postmenopausal women are at risk of developing an overactive bladder (OAB). Conventional vaginal estrogen has shown promise for symptom relief. Isoflavones have proven effective as an alternative to estrogen treatment against menopause-related symptoms. However, its effect on OAB symptoms has not been studied. This study investigates if fermented red clover isoflavones reduce OAB symptoms in postmenopausal women. In this randomized, double-blinded, placebo-controlled trial, women were administered red clover extract (RCE) or a placebo twice daily for three months. Women filled out the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) and Urinary Incontinence Short Form (ICIQ-UI-SF), together with a fluid intake and voiding diary. A total of 33 women (16 in the RCE group and 17 in the placebo group) were included in the analysis. Baseline demographics and OAB characteristics were comparable across groups. Intake of RCE did not lead to significant relief in most urinary bladder symptom measures, although a significant reduction in the bother of urinary urgency (p = 0.033) and a tendency towards a decreased ICIQ-OAB score were observed (p = 0.056). In contrast, the placebo exhibited a significant decrease in the ICIQ-OAB score (p = 0.021) and in some diary outcomes. We found that an intake of isoflavones did not relieve OAB symptoms in postmenopausal women.

Efficacy and Tolerability of Ich Nieu Khang Dietary Supplement for Overactive Bladder.

This study aims to assess the effectiveness and safety of plant-derived food supplement Ich Nieu Khang (INK) as a dietary supplement for overactive bladder (OAB) symptoms. A total of 50 patients 18-80 years of age with the diagnosis and symptoms of the OAB were enrolled in the study and followed up for 30 days. The INK treatment efficacy, in terms of changes in nocturnal and day-time urination frequency, urination incontinence episodes, level of OAB symptoms according to Homma's OABSS scale, sleep quality according to Pittsburg Sleep Quality Index (PSQI), and possible side effects of the INK phytotherapy, was evaluated. INK significantly improved all OAB symptoms scores with a reduction of average nocturia from 4.06 ± 1.53 to 1.14 ± 0.94, the daily average urination urgency from 7.67 ± 5.00 to 5. 82 ± 3.70, the daily average frequency of urination from 9.96 ± 4.04 to 8.00 ± 3.70, weekly average incontinence of urination from 0.92 ± 1.56 to 0.60 ± 1.02, and OABSS Homma's score decreased from 9.31 ± 1.44 to 6.8 ± 2.21. INK phytotherapy also resulted in sleep quality improvement by PSQI score decreasing from 13.11 ± 1.33 to 10.54 ± 2.21. There were no adverse effects and abnormalities in paraclinical parameters with INK therapy. The results of our study suggest that INK dietary supplement is effective and safe phytotherapy for patients with primary OAB symptoms within 30 days of treatment. Larger control clinical trials are warranted to confirm our findings and promote wider use of INK for OAB and possible other age-related urination disorders.

Efficacy of acupoint application in patients with overactive bladder: A randomized, placebo-controlled pilot trial.

OBJECTIVE: Conventional treatments for alleviating the symptoms of Overactive bladder (OAB) have been reported to have limited efficacy and a high rate of side effects. Traditional Chinese medicine (TCM) has been used in Asia countries because of its low side effects and being easy to operate. To confirm the efficacy of acupoint application treatment for alleviating OAB symptoms, a randomized and placebo-controlled pilot trial was conducted in this study. METHODS: All participants were randomly allocated into a treatment group or control group, receiving either a "Dinggui" acupoint application or placebo treatment for 4 weeks. The outcome measures were OAB symptom scores (OABSS), OAB questionnaire (OAB-q) scores, and TCM syndrome scores. Urine nerve growth factor (NGF) level, NGF normalized to urine creatinine (NGF/Cr), and maximum flow rate (Qmax) were also measured to evaluate the OAB symptoms. RESULTS: In total, 69 participants were included with 34 in the treatment group and 35 in the placebo-treated group. Treatment with "Dinggui" acupoint application showed a statistically significant decrease in OABSS scores (8.10±1.54 to 3.67±1.77), OAB-q scores (61.43±13.93 to 38.13±15.42), and TCM syndrome scores (15.60±5.98 to 9.20±4.82). The NGF and NGF/Cr were also observed meaningful changes in a decrease from 379.68 to 136.17 pg/ml and from 0.30 to 0.16 pg/mg, respectively. The Qmax value showed a significant increase from 14.40 to 24.05 ml/s. CONCLUSIONS: Treatment with "Dinggui" acupoint application could be considered an effective and alternative therapy for OAB management. Further studies with larger sample sizes and longer treatment periods are needed to investigate.

[Uroflowmetry: A follow-up tool for neurogenic bladder patients treated by transcutaneous tibial posterior stimulation?] / Débitmétrie : outil de suivi chez les patients avec vessie neurologique traités par neurostimulation tibiale postérieure ?

OBJECTIVE: Neurogenic bladders can suffer from overactivity, underactivity or dyssynergia depending on the level of the initial lesion. These symptoms can lead to severe alterations of the upper urinary tract. One of the first-line treatments is the transcutaneous tibial posterior stimulation (TTNS), which was demonstrated to be efficient on urodynamics. But it is an invasive, expensive and sometimes not patient-accepted examination, contrary to the uroflowmetry. The aim of this study is to assess the feasibility of a follow-up with a uroflowmetry when treated by TTNS and show that the maximum flow rate increased after treatment, displaying a better detrusor contraction. METHODS: In total, 38 patients with neurogenic bladder undergoing a 12-weeks TTNS treatment and with 2 uroflowmetries interpretable before and after treatment were included. The maximum flow rate (Qmax), the urinated volume and the post-void residual (PVR) were retrieved from the uroflowmetry, and the USP-score and the urinary discomfort were asked at each appointment. RESULTS: Qmax is increased from 17,53ml/s to 18,26ml/s, as well as the PVR (from 76,97ml to 79,16ml). Urinated volume is decreased from 241,4ml to 193,66ml. Patients feel enhanced after TTNS according to the decrease in the USP-score and the urinary discomfort scale. CONCLUSION: The increase of the cystomanometric capacity and the delay of the detrusor overactivity due to TTNS explains the reduction of the urinated volume and the increase of PVR. Increased Qmax might show a better voluntary bladder contraction, with a restraint due to the lack of abdominal pressure measurement during voiding.

National Trends in Third-Line Treatment for Overactive Bladder Among Commercially Insured Women, 2010-2019.

OBJECTIVE: To investigate whether the 2010 introduction of percutaneous tibial nerve stimulation and the 2013 introduction of intradetrusor onabotulinumtoxinA were associated with an increase in overall utilization of third-line treatments. METHODS: Using medical claims data from IBM Marketscan database 2010-2019, diagnosis codes were used to identify adult women with overactive bladder. Procedure codes were used to identify third-line treatments. The annual proportion of patients receiving third-line treatments was calculated, as well as the proportion of each treatment received. These were modeled as a function of treatment year using linear regression; a regression coefficient significantly different from 0 was considered evidence of a significant change in utilization over time. RESULTS: We identified 3,067,515 unique individuals with a diagnosis of overactive bladder, including 14,652 who initiated third-line treatments. The annual percentage of women with overactive bladder who initiated third-line treatment was 0.18% and did not change significantly over 10 years (P = .82). However, the proportion receiving sacral neuromodulation decreased significantly (P <.001), with a compensatory increase in intradetrusor onabotulinumtoxinA. Within 6 years of its introduction, onabotulinumtoxinA accounted for almost half of third-line treatments initiated. CONCLUSION: Overall, third-line therapies for non-neurogenic overactive bladder are utilized infrequently among privately insured women. Over the past decade, the introduction of new treatment options has led to a shift in the type of treatment initiated, rather than to an increase in the overall utilization of third-line therapies.

Reduced versus standard intradetrusor OnabotulinumtoxinA injections for treatment of overactive bladder.

BACKGROUND: Intradetrusor onabotulinumtoxinA injection is an effective advanced treatment for overactive bladder. While the effective dosages have been well studied, very little data exist on treatment efficacy using differing injection techniques. The objective of this study was to determine whether the efficacy of a reduced injection technique of 5 injection sites was noninferior to the standard technique of 20 injection sites of intradetrusor onabotulinumtoxinA for treatment of overactive bladder. METHODS: In this randomized noninferiority trial, men and women seeking treatment of overactive bladder with intradetrusor onabotulinumtoxinA injections were randomized to receive 100 units administered via either a reduced injection technique of 5 injection sites or a standard injection technique of 20 injection sites. Subjects completed a series of standardized questionnaires at baseline and at 4-12 weeks postprocedure to determine symptom severity and treatment efficacy. The primary outcome was treatment efficacy as determined by Overactive Bladder Questionnaire-Short Form with a noninferiority margin of 15 points. Secondary outcomes were incidence of urinary tract infection and urinary retention requiring catheterization. RESULTS: Data from 77 subjects were available for analysis with 39 in the control arm (20 injections) and 38 in the study arm (5 injections). There was a significant improvement in both arms from baseline to follow-up in Overactive Bladder Questionnaire-Short Form and International Consultation on Incontinence Questionnaire scores (p < 0.001). Overall treatment success was 68% with no statistically significant difference between arms. A significant difference between arms was found on the Overactive Bladder Questionnaire-Short Form quality of life survey favoring the control arm (confidence interval [CI]: 0.36-20.5, p = 0.04). However, there were no significant differences between arms in the remaining validated questionnaires. The study arm did not demonstrate noninferiority to the control arm. Subjects in the study arm were significantly more likely to express a willingness to undergo the procedure again (odds ratio = 3.8, 95% CI: 1.42-10.67, p = 0.004). Adverse events did not differ between arms. CONCLUSIONS: A reduced injection technique for administration of intradetrusor onabotulinumtoxinA demonstrates similar efficacy to the standard injection technique but did not demonstrate noninferiority. Subjects preferred the reduced injection technique over the standard technique. A reduced injection technique is a safe and effective alternative to the standard technique.

Physiotherapeutic assessment and management of overactive bladder syndrome: a case report.

INTRODUCTION: Overactive Bladder Syndrome (OAB) has multiple treatment methods including pharmacotherapy, pelvic floor muscle training, electrostimulation, or surgery. One of the nonpharmacological treatment options is physiotherapy including pelvic floor muscle training. CASE DESCRIPTION: The patient was a 25 year-old woman who attended the urogynecological physiotherapy consulting room due to frequent sensations of bladder pressure. Manual inspection and ultrasound imaging was used by the physiotherapist in order to assess the function of pelvic and abominal structures. The patient reported pain symptoms during examination of several pelvic floor and abdominal muscles. The patient was judged eligible for urogynecological physiotherapeutic treatment. Manual therapy of the lumbopelvic hip complex, manual therapy per vaginum, manual therapy of the musculus piriformis, and therapy of the superficial back line myofascial meridian and the lateral line myofascial meridian were used. During the final session, the patient reported an improvement in relation to the symptoms presented, most notably no frequent feeling of bladder pressure. CONCLUSIONS: Treatment of OAB is often a multistage process involving application of different therapies by a multidisciplinary team. For this patient, physiotherapy assessment and intervention were an integral part of the conservative management of OAB.

Quality of life and psychological aspects in children with overactive bladder treated with parasacral transcutaneous electrical nerve stimulation - A prospective multicenter study.

OBJECTIVE: To assess the impact of parasacral transcutaneous electrical nerve stimulation (parasacral TENS) on quality of life (QoL) and psychological aspects in children treated for overactive bladder (OAB). METHODS: This international, multicenter, prospective cohort study involved individuals of 6-16 years of age under TENS treatment for OAB. The study was conducted between June 2016 and December 2019 in four participating centers: two in Australia, one in Germany and one in Brazil. Patients with anatomical and/or neurological abnormalities of the urinary tract were excluded. Questionnaires were applied before and after parasacral TENS treatment: the Dysfunctional Voiding Symptom Score (DVSS), used in Brazil, or the International Consultation on Incontinence Questionnaire - Pediatric Lower Urinary Tract Symptoms (ICIQ-CLUTS), used in Germany and Australia, to analyze urinary symptoms; the Strengths and Difficulties Questionnaire (SDQ) to assess emotional and behavioral aspects; and the Pediatric Incontinence Questionnaire (PinQ) for bladder-specific Qol. RESULTS: Fifty-three patients (28 girls and 25 boys) with a mean age of 8.64 ± 2.63 years were included. Median DVSS was 11 (range 6-13.5) and 3 (range 0-7), (p < 0.001), and median ICIQ-CLUTS was 12 (range 9-14) and 9 (range 5.7-12), (p < 0.001), before and after treatment, respectively. Median PinQ score decreased from 47.8 (range 38.9-59.7) to 39 (range 29-53.15) following treatment (p = 0.04). Median total SDQ score before and after treatment was 17 (range 13.5-21) and 15 (range 12-21), respectively (p = 0.939). CONCLUSION: Parasacral TENS was associated with a significant improvement in urinary symptoms and QoL; however, there was no change in psychological symptoms, as measured using the SDQ.

Stimulation of the Tibial nerve Repetitively to Improve Incontinence in Parkinson's Electronically (STRIPE trial): a randomised control trial of tibial nerve stimulation for bladder symptoms in Parkinson's disease using a self-contained wearable device.

BACKGROUND: Bladder symptoms are common in Parkinson's disease (PD), affecting half of all individuals. These have significant impact on quality of life as well as implications for morbidity, contributing to falls and hospital admission. The treatment of bladder symptoms can be complicated by the tendency to side-effects in people with PD including cognitive impairment and gait instability with anti-muscarinics. The development of new, better treatments is therefore warranted. Tibial nerve stimulation is a form of neuromodulation demonstrated to improve overactive bladder symptoms in non-neurogenic cohorts. Previously requiring hospital attendance, we aim to explore the use of this intervention using a simple device that can be used by patients at home. METHODS: STRIPE is a phase II randomised control trial of tibial nerve stimulation delivered by the Geko™ device, a small, self-adhesive neuromuscular stimulation device currently used for thromboembolism prophylaxis post-surgery. Active tibial nerve stimulation will be compared to sham stimulation, with participants blinded to treatment allocation and undertaking outcome assessment whilst still blinded. Participants will be asked to self-administer stimulation at home twice per week, for 30 min per session, over the course of 3 months. Primary outcome measure will be the International Consultation on Incontinence Overactive Bladder Questionnaire (OAB) at week 12. Secondary outcomes will include pre- and post-intervention bladder diary (frequency, urgency episodes, nocturia), patient perception of global change, bowel function and bladder-related quality of life. Participants will be recruited from the Proactive Integrated Management and Empowerment (PRIME) cross-sectional trial in which participants have been screened for bladder symptoms and invited to take part, as well as clinician referral from around the region. DISCUSSION: This trial will involve a randomised control trial of a novel and easy to use method of delivering tibial nerve stimulation for PD in the patient's own home. This may potentially have huge benefit, avoiding the problems with side effects that can be seen with anti-muscarinics and providing a new potential modality of treatment. TRIAL REGISTRATION: ISRCTN11484954. Registered on 22 June 2021.

Agreement between the visual analogue scale (VAS) and the dysfunctional voiding scoring system (DVSS) in the post-treatment evaluation of electrical nerve stimulation in children and adolescents with overactive bladder.

INTRODUCTION: Electrical nerve stimulation is one of the most commonly used and well-tolerated treatments for overactive bladder (OAB); however, different studies have used different instruments to assess patients' response to treatment. OBJECTIVE: To analyze agreement between use of the visual analogue scale (VAS) and the Dysfunctional Voiding Scoring System (DVSS) for assessing improvement in urinary symptoms following electrical nerve stimulation treatment in children and adolescents with OAB. STUDY DESIGN: A cross-sectional analytical study including children and adolescents of 4-17 years of age diagnosed with OAB who underwent 20 sessions of transcutaneous (TENS) or percutaneous (PENS) electrical nerve stimulation. The DVSS and the VAS were used to assess daytime urinary symptoms before and following treatment. While the DVSS was always applied by a physician, the VAS was applied separately by a physiotherapist and then by a physician. Treatment was considered successful when the DVSS score was zero and the VAS score was ≥90%. Correlations between post-treatment VAS and DVSS scores were evaluated using the kappa coefficient. The VAS scores evaluated by the different professionals were compared for agreement using intraclass correlation and the Bland-Altman plot. RESULTS: Data from 49 cases were available for analysis. Of these, 27 (55.1%) were girls. Mean age was 7.1 ± 2.6 years. There was agreement between the two instruments used, the DVSS and the VAS, in 36/49 patients (73.5%), with a moderate Kappa of 0.44. There was moderate agreement between the VAS scores applied by the two different professionals. DISCUSSION: imitations of the present study include the small sample size and the fact that the inter-observer evaluation was conducted following a single sequence, i.e. all the patients were first evaluated by the physiotherapist and then by the physician, which may have biased answers and the post-treatment VAS scores. Furthermore, although the child participated actively in completing the questionnaires, in cases of divergent answers, the questions were redirected to the responsible adult, and the final answer may not fully represent the patient's true situation. CONCLUSION: The present study found moderate agreement between the DVSS and the VAS, and moderate agreement between VAS scores when the instrument was applied by two different professionals. Although both tools appear to be important, and possibly complementary, a DVSS score of zero precludes the need to apply the VAS.

The effect of hyperbaric oxygen therapy on bladder symptoms of female patients with overactive bladder.

Overactive bladder (OAB) is a disease with symptoms such as feelings of urgency, nocturia, and frequent urination which is usually accompanied by urinary incontinence. We aimed to assess the effect of hyperbaric oxygen (HBO2) therapy on the symptoms of female patients with overactive bladder (OAB). This study is a prospective observational cohort study. The patients were analyzed into two groups. The patients who received HBO2 therapy were in Group 1, and the patients who received mirabegron treatment were in Group 2. The symptom scores and quality of life scores of the patients before and after treatment were recorded and compared. Significant improvement in symptom scores were seen in both groups after treatment compared to baseline. The study included 31 patients in Group 1 and 44 patients in Group 2. The mean changes in the ICIQ-SF, OAB-V8, and IIQ-7 scores in the third month of treatment in Group 1 were 4.12 ± 3.51, -10.70 ± 6.92, and -4.51 ± 2.68, respectively. The corresponding mean score changes in Group 2 were -4.31 ± 3.16, -11.22 ± 5.93, and -3.68 ± 2.67, respectively. The mean changes in all three scores were not significantly different between Groups 1 and 2 (p = 0.81, 0.73, and 0.19, respectively). We observed that HBO2 treatment improved quality of life by reducing the symptom score in patients with OAB. Moreover, this effect continued in the third month after the treatment. Considering the efficacy and side effect profiles of the available treatments, HBO2 therapy may be a new treatment alternative in OAB.

Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStim™ therapy evaluation.

AIMS: The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre-implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle. METHODS: Patients with overactive bladder were enrolled in this study. The primary objective of this study was to determine the proportion of subjects who demonstrated motor or sensory response(s) during lead placement using the InterStim PNE lead. Additional measures included the Patient Global Impression of Improvement (PGI-I), patient satisfaction at the end of therapy evaluation, and change in bladder symptoms from baseline to the end of therapy evaluation (1-week follow-up visit). RESULTS: One-hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. Of those, 108 had a successful procedure and 107 completed the 1-week follow-up visit. Ninety-nine percent of subjects (109/110) had a motor or sensory response during needle placement (95% confidence interval [CI]: 95%-100%) and 97% of subjects (107/110) had a motor or sensory response during lead placement (95% CI: 92%-99%). The majority of subjects (88%, 95/108) reported their bladder condition was better at the follow-up visit compared to before the PNE implant procedure, as reported in PGI-I. Subjects reported being satisfied with how the therapy impacted their voiding symptoms (82%, 88/108) and that they would recommend this therapy (87%, 94/108) to other patients. Symptom improvement was demonstrated with urinary urge incontinence subjects having an average of 4.2 ± 3.4 urinary incontinence episodes/day at baseline and 2.2 ± 2.5 at follow-up, and urinary frequency subjects having an average of 12.5 ± 4.4 voids/day at baseline and 10.5 ± 4.3 voids/day at follow-up. Lead removal was deemed to be easy and safe by the implanting physician, with a total of three adverse device effects in 3/110 subjects. No event was categorized as serious and all were resolved without sequelae. CONCLUSIONS: The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high rate of motor or sensory response during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity.

Machine learning provides an accurate prognostication model for refractory overactive bladder treatment response and is noninferior to human experts.

OBJECTIVE: The increasing wealth of clinical data may become unmanageable for a physician to assimilate into optimal decision-making without assistance. Utilizing a novel machine learning (ML) approach, we sought to develop algorithms to predict patient outcomes following the overactive bladder treatments OnabotulinumtoxinA (OBTX-A) injection and sacral neuromodulation (SNM). MATERIALS AND METHODS: ROSETTA datasets for overactive bladder patients randomized to OBTX-A or SNM were obtained. Novel ML algorithms, using reproducing kernel techniques were developed and tasked to predict outcomes including treatment response and decrease in urge urinary incontinence episodes in both the OBTX-A and SNM cohorts, in validation and test sets. Blinded expert urologists also predicted outcomes. Receiver operating characteristic curves were generated and AUCs calculated for comparison to lines of ignorance and the expert urologists' predictions. RESULTS: Trained algorithms demonstrated outstanding accuracy in predicting treatment response (OBTX-A: AUC 0.95; SNM: 0.88). Algorithms accurately predicted mean decrease in urge urinary incontinence episodes (MSE < 0.15) in OBTX-A and SNM. Algorithms were superior to human experts in response prediction for OBTX-A, and noninferior to human experts in response prediction for SNM. CONCLUSIONS: Novel ML algorithms were accurate, superior to expert urologists in predicting OBTX-A outcomes, and noninferior to expert urologists in predicting SNM outcomes. Some aspects of the physician-patient interaction are subtle and uncomputable, and thus ML may complement, but not supplant, a physician's judgment.

Transcutaneous electrical nerve stimulation as add-on therapy in children receiving anticholinergics and/or mirabegron for refractory daytime urinary incontinence: A retrospective cohort study.

AIMS: To investigate if children with daytime urinary incontinence (DUI) and overactive bladder (OAB) refractory to standard urotherapy and medicinal treatment, would experience improvement in symptoms after add-on treatment with transcutaneous electrical nerve stimulation (TENS). METHODS: Children were retrospectively enrolled from tertiary referral centers at Aarhus and Aalborg University Hospitals. All data were retrieved from the patients' journals. All children were prescribed TENS as an add-on treatment to the highest-tolerable dose of medicinal treatment in a standardized regime of 2 h a day for around 3 months. Primary endpoints were the number of wet days per week (WDPW) and incontinence episodes per day. Effect of treatment was defined as greater or equal to 50% reduction in the frequency of DUI episodes. Secondary endpoints were to establish predictive factors for the effect of treatment using logistic regression. RESULTS: Seventy-six children diagnosed with DUI and OAB refractory to treatment with standard urotherapy and pharmacological treatment, at the age of 5-16 years were included from February 2017 to February 2020. A reduction in WDPW (from 6.31 [5.86-6.61] to 4.27 [3.45-4.90], p < 0.05) and incontinence episodes per day (from 2.45 [1.98-2.91] to 1.43 [1.07-1.80], p < 0.05) was observed. Twelve patients became completely dry. At 6 months follow-up, seven of the 12 complete responders had relapsed while five remained dry. A history of constipation before TENS was a predictor of poor treatment response (p = 0.016). CONCLUSIONS: TENS as add-on to anticholinergic treatment seems effective in a number of children with treatment-refractory DUI.

Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study.

BACKGROUND: SOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data. OBJECTIVE: To analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation. DESIGN, SETTING, AND PARTICIPANTS: Twenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 ± 3.7 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test. RESULTS AND LIMITATIONS: Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p < 0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p < 0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4 ± 15.3 mo. CONCLUSIONS: This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life. PATIENT SUMMARY: Our study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder. This trial is registered at ClinicalTrials.gov as NCT02186041.

Mirabegron improves erectile function in men with overactive bladder and erectile dysfunction: a 12-week pilot study.

Phosphodiesterase type 5 inhibitors (PDE5i) is the only approved oral treatment for erectile dysfunction (ED) in the US, and alternative management remains necessary when this treatment fails or is contraindicated. Targeting other pathways than the NO-cGMP pathway and/or combining this approach with PDE5i may introduce new treatments for men who are unresponsive to PDE5i. This study aims to evaluate whether Mirabegron improves erectile function in men with concurrent overactive bladder and mild to moderate ED. Twenty subjects, 40-70 years old, registering International Index of Erectile Function (IIEF) score 11-25 and International Prostate Symptom Score 8-20, were treated with Mirabegron therapy for 12 weeks. Study participants were re-administered IIEF and OAB-q questionnaires on weeks 2, 4, 8, and 12 and assessed for adverse events. The primary and secondary endpoints were an increase in the IIEF-5 score of 4 units and a decrease in the Overactive Bladder questionnaire (OAB-q) symptom severity score of 10 units between study time points. Thirteen men completed the 12-week study. Mirabegron treatment improved the IIEF-5 scores in five patients (38.4%) by 4 points or more, whereas IIEF-5 scores were not affected by Mirabegron treatment in eight patients (61.5%). There were no clinically relevant decreases in the IIEF-5 score. Significant improvements were observed in intercourse satisfaction at week eight compared to baseline (p = 0.01). Orgasmic function and sexual desire were not affected by Mirabegron treatment. As expected, Mirabegron treatment reduced OAB symptoms based on OAB-q short form (p = 0.006) and OAB-q total health-related quality of life (HRQL) scores compared to baseline (p = 0.03). Residual bladder volumes were not affected by treatment. No serious side effects were reported during the study period. This study suggests that Mirabegron may improve both EF and OAB-related symptoms in some individuals without causing serious adverse events.

[Transcutaneous stimulation of the posterior tibial nerve modifies the sympathetic skin response and improves overactive bladder syndrome: Case series and possible diagnostic test]. / La estimulación transcutánea del nervio tibial posterior modifica la respuesta simpática cutánea y mejora el síndrome de vejiga hiperactiva: serie de casos y posible prueba diagnóstica.

OBJECTIVE: (a) To assess the effect of transcutaneous neuromodulation (TNM) of the posterior tibial nerve plus biofeedback on the sympathetic skin response (SSR). (b) Evaluate its effect on clinical symptoms. (c) Consider SSR as a probable neurophysiological test useful both for diagnosis and for follow-up in patients with overactive bladder (OAB). (d) Evaluate its cost compared to other techniques. MATERIAL AND METHODS: A prospective quasi-experimental before and after study in 10 OAB patients. OUTCOME VARIABLES: daytime (DUF) and nighttime (NUF) urinary frequency, strength of the pelvic floor muscles measured by manometry (maximum and mean pressure) and sympathetic skin response (SSR). RESULTS: DUF improved from 10.3±5.45 to 5.9±2.42 episodes (P=.0050). The NUF improved from 2.4±1.5 to 0.6±0.69 episodes (P=.0012). The maximum pressure ranged from 34.7±16.51 to 39.7±3.65mmHg (P=.0195). The mean pressure of the pelvic floor muscles improved from 6.6±3.65 to 9.3±5.43mmHg (P=.0333). SSR changed from 100% hyperexcitability prior to treatment to 50±14.14% (P=.0000). CONCLUSION: TNM plus biofeedback could modify SSR and improve clinical and manometry variables in a series of patients with OAB. The probable diagnostic and prognostic utility of this neurophysiological test in OAB and detrusor hyperactivity is reported for the first time. A larger sample study is needed to confirm the promising findings seen in this preliminary study.

Time until maximum flow rate uroflowmetry: A new parameter for predicting failure of transcutaneous electrical nerve stimulation (TENS) in treating children and adolescents with overactive bladder.

AIM: To analyze uroflowmetry as a predictor of the outcome of treatment with parasacral transcutaneous electrical nerve stimulation (TENS) in patients with pure overactive bladder. METHODS: Thirty-eight patients of 5-16 years of age were included in this prospective cohort study. All the patients had been seen at a referral clinic between 2006 and 2015. All had a diagnosis of pure overactive bladder and were treated with TENS. Parameters established at pretreatment uroflowmetry were evaluated, with patients then being separated into two groups based on their visual analogue scale (VAS) score immediately following TENS. The variables analyzed at uroflowmetry were: maximum flow rate, curve pattern (bell or tower-shaped), time until maximum flow and voided volume. RESULTS: The mean age of the children evaluated was 7.26 years (SD: 2.62) (95%CI: 6.4-8.13) and 73.7% were girls. No association was found between maximum flow rate, curve pattern (bell or tower-shaped) or voided volume and the complete resolution of symptoms following treatment. Nevertheless, a shorter time until maximum flow was associated with a greater likelihood of treatment failure. CONCLUSION: The time until maximum flow rate before treatment is a potential predictor of the outcome of TENS treatment.

Do we need more patient-friendly treatment options for overactive bladder (OAB)?

AIMS: To collect feedback from subjects diagnosed with overactive bladder (OAB) on its impact on their quality of life, their satisfaction with current treatment options, and to assess nonsurgical, tibial nerve stimulation as a treatment option. METHODS: Subjects were asked a variety of questions about the impact of OAB on their lives, their satisfaction with current and previous treatment approaches. Subjects evaluated the comfort of a nonworking prototype garment and were given electrical stimulation over their posterior tibial nerve to assess comfort and tolerability. Electromyographic (EMG) signals were recorded. RESULTS: A total of 40 subjects with OAB symptoms were evaluated in the study. Urgency (55%), frequency (47.5%), nocturia (40%), and incontinence (30%) were the most bothersome symptoms. At the time of the study only 32.5% of the subjects were treating their OAB symptoms. Of those that had tried and discontinued treatments, most had failed medications (n = 14) due to no improvements or side effects. Only 2 subjects found stimulation to be uncomfortable before an EMG signal could be detected. The most common word used to describe the feeling of stimulation was "constant," followed by "tingling," "vibrating," and "comfortable." CONCLUSIONS: Most subjects who had tried OAB treatments were dissatisfied and discontinued their use. A new patient-friendly approach to OAB therapy that delivers efficacy but overcomes drawbacks associated with currently available treatments is needed. Subjects found electrical stimulation over the tibial nerve to be comfortable and tolerable and this should be considered as an alternative treatment approach for OAB.