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Background Overactive bladder syndrome is common, with a prevalence of 12–17% among adults. Posterior tibial nerve stimulation is the primary nonpharmacological and conservative treatment for overactive bladder syndrome. While several human brain imaging studies have shown the involvement of supraspinal centers in bladder control, a literature review has found that no research has specifically investigated cortical stimulation through transcranial direct current stimulation as a treatment for overactive bladder syndrome in women. Therefore, this study aims to assess the potential benefits of transcranial direct current stimulation (tDCS) and compare them with the effects of posterior tibial nerve stimulation on overactive bladder syndrome. Methods/design The random allocation method will be used to divide the participants into two groups. Group 1 ( n  = 19) will undergo pelvic floor muscle training and transcutaneous tibial nerve stimulation. Group 2 ( n  = 19) will undergo pelvic floor muscle training and transcranial direct current stimulation. The transcranial direct current stimulation for group 2 will consist of 12 sessions occurring thrice a week, each lasting for 20 min. Anodal tDCS will be administered to FPz targeting the medial prefrontal cortex (mPFC) for 12 sessions, with the cathode electrode positioned between Oz and inion at an intensity of 2 mA for 20 min. Discussion It is believed that utilizing an approach involving non-invasive electrical stimulation of the cortex could lead to a more efficient treatment for individuals with overactive bladder. Additionally, it is theorized that combining the effects of tDCS and pelvic floor muscle training could present an innovative technique for alleviating the negative impacts of overactive bladder syndrome. Ultimately, this new method could provide help for patients who have not responded to conventional therapy. Trial registration Iranian Registry of Clinical Trials (IRCT) ID: IRCT20090301001722N26, registration date: May 17, 2023. https://en.irct.ir/ .

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.

Introduction Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition creating a wide range of urologic and pain symptoms. There is currently limited evidence to understand the mechanisms of IC/BPS. There have been recent studies suggesting that altered function in brain motor areas, particularly the supplementary motor cortex (SMA), relates to altered bladder sensorimotor control and may play an important role in IC/BPS. This study aims to provide evidence that non-invasive stimulation targeting the motor cortex may help reduce IC/BPS pain, as well as better understand the neural mechanism by which this stimulation targets neuromuscular dysfunction. This study is a two-group quadruple-blinded randomized controlled trial (RCT) of active vs. sham repetitive transmagnetic stimulation (rTMS). In addition, our study will also include functional magnetic resonance imaging (fMRI), pelvic floor electromyography (EMG), pelvic exam, and outcome measures and questionnaires to further study outcomes. Ethics and dissemination All aspects of the study were approved by the Institutional Review Board of the University of Southern California (protocol HS-20–01021). All participants provided informed consent by the research coordinator/assistants. The results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences. Trial registration ClinicalTrials.gov NCT04734847. Registered on February 1, 2021.

Waterjet dissection of the inferior hypogastric plexus (IHP) resulted in a more rapid return of normal urodynamics than blunt dissection (control group) in patients who received laparoscopic nerve-sparing radical hysterectomy (NSRH) in a randomized controlled study. However, the definite reasons for these results were unknown. This subgroup analysis compared the neural areas and impairment in the IHP uterine branches harvested during NSRH as an alternative to the IHP vesical branches between the waterjet and control groups. This study included samples from 30 eligible patients in each group of the trial NCT03020238. At least one specimen from each side of the IHP uterine branches was resected. The tissues were scanned, images were captured, and the neural component areas were calculated using the image segmentation method. Immunohistochemical staining was used to evaluate neural impairment. The control and waterjet groups had similar areas of whole tissues sent for evaluation. However, the control group had significantly fewer areas (median 272158 versus 200439 μm 2 , p = 0.044) and a lower percentage (median 4.9% versus 3.0%, p = 0.011) of neural tissues. No significant changes in immunohistochemical staining were found between the two groups. For patients with residual urine ≤100 and >100 ml at 14 days after NSRH (42 and 18 patients, respectively), there were significantly different percentages of neural tissues in the resected samples (p < 0.001). Hence, Due to the accurate identification of IHP during NSRH, the waterjet dissection technique achieved better urodynamic results.

Background Overactive bladder (OAB) is defined as “urgency, with or without urge incontinence, usually with frequency and nocturia”. Acupuncture is one of the most popular alternative treatment methods for OAB. Little established evidence is available to support the effectiveness of acupuncture for OAB. This study is a pioneer randomized, double-blinded, sham-controlled trial to assess the effectiveness and safety of acupuncture in the elderly population with overactive bladder in Hong Kong. Methods/design This is a randomized, double-center, patient and outcome assessor blinded, sham-controlled trial. The study sample size is 100 patients. Eligible subjects aged between 60 to 90 years old will be recruited into this study. All subjects will be randomly allocated into the active acupuncture group or sham acupuncture group in a 1: 1 ratio. Participants who are allocated into the active acupuncture group will receive a standardized 30-min real acupuncture treatment session for a total of 16 sessions on the top of standard routine care, whilst those who are randomized to the sham acupuncture arm will receive sham acupuncture in addition to standard routine care. Non-penetrating needles will be utilized as sham acupuncture. The primary outcome measure is the 7-day voiding diary and the secondary outcome measures are urine nerve growth factor (NGF) level, the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) and OAB Symptom Score (OABSS). All outcome measures will be collected at baseline, the end of treatment and 3 months after treatment completion. Discussion The objectives of this study include (1) to evaluate the effectiveness and safety of acupuncture treatment in patients with OAB on reduction in the frequency of incontinence episodes as derived from a 7-day voiding diary, (2) to evaluate whether acupuncture treatment could improve subjective symptoms in patients with OAB and (3) to examine the feasibility of using NGF as a biomarker for overactive bladder and test correlation with the effectiveness of acupuncture intervention. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for treatment of OAB. Trial registration Chinese Clinical Trial Registry, ChiCTR-INR-16010048 . Registered on 29 Nov 2016.

ObjectiveNeurogenic bladder (NGB) is a serious complication after spinal cord injury (SCI), a destructive neurological disease. This study focused on exploring the efficacy of the magnetic stimulation of sacral nerve roots combined with Tui-na in treating NGB after SCI.MethodsOne hundred patients with NGB after SCI were studied, and intermittent clean catheterization was performed with a water intake program, and patients were grouped into four groups by the random number table method: general treatment group, Tui-na group, magnetic stimulation group, and combined treatment group. A series of relevant factors (voiding diary, urodynamics, and quality of life scores) and clinical efficacy of patients in the four groups before and after treatment were observed.ResultsThe magnetic stimulation of sacral nerve roots alone, Tui-na alone, and the combination of both were all effective in improving bladder function and quality of life in patients with NGB after SCI, including improvements in voiding frequency, single urine output, maximum urine output, residual urine output, bladder volume and quality of life scores in patients with NGB after SCI. The efficacy of the magnetic stimulation of sacral nerve roots combined with Tui-na was better than that of the magnetic stimulation of sacral nerve roots alone and the Tui-na alone.ConclusionThis research demonstrates that the magnetic stimulation of sacral nerve roots combined with Tui-na treatment could effectively improve the urinary system and the quality of life of patients with NGB after SCI, which is worthy of clinical promotion and application.

Background Electroacupuncture has been used for treatment in patients with overactive bladder. This study was conducted to evaluate the efficacy and safety of electroacupuncture for treating overactive bladder of postmenopausal women. Methods/design This is a multicenter, randomized controlled, parallel clinical trial. Two hundred ninety participants with overactive bladder syndrome will be recruited from Dongguk University Bundang Oriental Hospital and Cheonan Korean Medicine Hospital of Daejeon University and randomly allocated into one of two groups in a 1:1 ratio. One group will receive electroacupuncture (EA) and the other acupuncture (AC). The allocation will be concealed from both participants and assessors. The study period will be about 10 weeks, including 6 weeks of electroacupuncture or acupuncture treatment and a four week follow-up period. Both EA group and AT group will undergo acupuncture at 7 fixed points, and the EA group will undergo electronic stimulation at 6 points. The primary outcome will be the average number of micturitions per 24 h based on a 3-day bladder diary. The secondary outcome will comprise the 3-day bladder diary, the overactive bladder symptom score and the results of the King’s health questionnaire. Discussion The results of this trial will provide information regarding the efficacy and safety of electroacupuncture for treating overactive bladder in postmenopausal women. Trial registration ClinicalTrials.gov, NCT03260907 . Registered on 24 August 2017.

Background Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions. Methods/design The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form), and — regarding secondary and tertiary outcomes — higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1–5 3x/week, 3x/day; weeks 6–16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions (3x/week, 1x/day) until the 6-month follow-up. To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) between and within the two groups at ten time points (before intervention, physiotherapy sessions 2–9, after intervention) ANOVA models for longitudinal data will be applied. Discussion This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately. Trial registration NCT02318251 ; 4 December 2014 First patient randomized: 11 March 2015

Background There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence. Methods/Design One hundred twenty subjects with stress urinary incontinence will be randomized in a 1:1 allocation to either active or sham magnetic stimulation using computer-generated, permuted blocks of variable sizes. Subjects will receive 2 sessions of magnetic stimulation per week for 8 weeks (16 sessions total). The primary outcome is the improvement in severity of involuntary urine loss based on the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form at the end of treatment sessions compared with baseline. Secondary outcomes include cure, stress urinary incontinence–related symptoms (incontinence episode frequency, urine loss in 1-hour pad test, pelvic floor muscle strength) and health-related quality of life (Patient Global Impression of Improvement, International Consultation on Incontinence Questionnaire–Lower Urinary Tract Symptoms Quality of Life and EQ-5D). The safety of magnetic stimulation will also be assessed. Besides evaluation of clinical treatment effectiveness, cost-effectiveness analysis using patient-reported outcomes will be performed. Discussion This trial is designed to provide pending outcome information on this non-invasive treatment option. We intend to acknowledge the existing flaws in previous clinical trials and determine conclusively whether magnetic stimulation is effective for stress urinary incontinence. Trial registration ClinicalTrials.gov Identifier: NCT01924728 . Date of Registration: 14 August 2013.

Objective:To investigate the bladder function recovery and quality of life (QOL) using nerve-sparing radical hysterectomy (NSRH) in treating early invasive cervical carcinoma.Methods:Subjects included patients who underwent radical hysterectomy by laparotomy for early-stage cervical carcinoma. Thirty-one patients were randomly assigned to 2 groups: group A, 15 patients who underwent NSRH; and group B, 16 patients who underwent classical radical hysterectomy. We observed the patients' general clinical information, surgical characteristics, postoperative vital signs, pathological findings, adjuvant therapies, and adverse effects. A urodynamic study was used to assess the bladder function. The patients' QOL was evaluated by Functional Assessment of Cervical Cancer Therapy (FACT-Cx).Results:Twenty-nine patients completed the study. No significant differences were found in age, body mass index, surgery characteristics, pathological findings, adjuvant therapies, and main adverse effects between the 2 groups (P > 0.05). The postoperative time of bladder function recovery in group A was obviously earlier than that in group B (P < 0.05). The urodynamic study showed that the extent of bladder function recovery in group A was better than that in group B (P < 0.05). The QOL in group A evaluated 1 year after operation was improved compared with that in group B (P < 0.05). The QOL analysis showed that group A did much better than group B in social and family life, emotional well-being, working status, and the symptom correlated with the operation (P < 0.05). No significant differences were found in basic bodily functions (P > 0.05).Conclusions:Nerve-sparing radical hysterectomy is a safe and reliable technique for early invasive cervical carcinoma. The postoperative bladder function recovery and the patients' QOL were improved after NSRH compared with the control group. Therefore, NSRH could be an alternative management to modify the classical surgery for cervical carcinoma with International Federation of Gynecology and Obstetrics stages IB1 to IIA.