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49 active trials for Overactive Bladder

Overactive Bladder Treatment Using StimRouter Neuromodulation System: A Prospective Randomized Trial

Approximately 20 Study Sites will participate over total 24 months. Study population will consist of adults age 22 or over, reporting overactive bladder (OAB) symptoms for at least 3 months. Primary Study Objectives: To assess efficacy of the StimRouter stimulation in improving OAB symptoms of urgency and frequency as measured by Patient Voiding Diary when targeting the posterior tibial nerve To assess safety of the StimRouter therapy for the indication of OAB Secondary Study Objective: To evaluate efficacy of the StimRouter therapy in addressing urinary urge incontinence as measured by the Patient Voiding Diary Study Design is prospective, multi-center, randomized, double-blinded Primary Endpoint: The primary efficacy endpoint will be the difference between the investigational and control groups in proportion of responders, where Responder is defined as having ?50% improvement in average voiding frequency above the normal value of 8 (those returning to normal voiding based on 7-day average voids/leak episodes < 9, will be categorized as achieving half or more reduction) AND having ?50% improvement in average number of moderate to severe urgency episodes, at approximately three months after programming. Secondary Endpoint: Secondary endpoint will be the difference between the investigational and control groups in proportion of patients with reduction by half or more in urinary urge incontinence as measured by the average number of urge incontinence episodes per day.

Start: February 2017
Experience Sampling Method in OAB Patients

Rationale: The overactive bladder syndrome is diagnosed clinically by using the ICS criteria of ?8 micturitions and at least 1 urgency episode per 24 hours. To determine whether patients fit the criteria, micturition diaries ('sensation-related bladder diaries') and other symptom questionnaires with considerable limitations are used. This makes it difficult to get a good impression of the fluctuation of complaints during the day / week. These limitations are overcome using the Experience Sampling Method (ESM). This is an electronic questioning method which is characterized by repeated and random, momentary assessments in the subject's current environment and state. This study follows other successful ESM studies done within the Gastroenterology and Psychiatry Department. The aim of this study is to evaluate if the ESM is more accurate in the assessment of urological complaints in OAB compared to the current assessment with the use of the sensations-related bladder diaries (SR-BDs) and retrospective questionnaires. Furthermore the aim is to assess the reliability and validity of this OAB-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and assessment of triggers for symptoms in OAB. Objective: To evaluate the accuracy of the ESM to assess urological complaints in OAB compared to SR-BDs and retrospective questionnaires. To assess content validity, reliability and the accuracy to validate the developed ePRO in OAB patients. Study design: The ESM study is a multicentre, prospective, cross-sectional study. Study population: 66 OAB patients will be recruited at the outpatient Pelvic Care Centre in Maastricht UMC+, Zuyderland Hospital and University Hospital Antwerp, 66 healthy volunteers will be recruited as well. Methods: In a period of 7 days, participants will fill out an electronic ESM assessment at 10 random moments during the day. Moreover, they will fill out a sensation-related bladder diary (SR-BD) during the last three consecutive days of filling out the ESM and several symptom questionnaires at the end of the study period. Main study endpoints: The main study outcome comprehends the psychometric properties of the PROM for symptom assessment of OAB symptoms. Secondary outcomes are increase in ESM score for OAB symptoms and environmental and psychosocial factors (e.g. as measured by the PROM) from one time point (t-1) to the next (t).

Start: August 2018