Active clinical trials for "Urinary Bladder, Overactive"

Purpose: This is a pilot randomized double-blind placebo controlled trial of anticholinergic or beta-3 agonist medication with or without concomitant probiotic therapy in women initiating medication therapy for overactive bladder (OAB). The aims of this study are to: Explore how concomitant probiotic therapy influences response to medication for OAB in a randomized controlled trial Investigate whether 4 weeks of probiotic therapy alters the urinary microbiome Assess for predictors of response to therapy Participants: Women 18 years of age or older presenting to the Division of Urogynecology and Reconstructive Pelvic Surgery clinic with OAB/UUI or UUI-predominant mixed incontinence who desire nonsurgical therapy will be eligible for participation. Procedures (methods): The study will be conducted over a two-year time frame and the primary outcome will be subjective improvement in symptoms as assessed by the Patient Global Impression of Improvement (PGI-I) validated questionnaire at 4 weeks after initiating anticholinergic or beta-3 agonist medication and study drug. The study aims to recruit up to 140 participants randomized in a 1:1 ratio to either concomitant probiotic or placebo medication.

This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).

To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment of overactive bladder under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be the improvement value of overactive bladder symptom score (OABSS) after 12-week treatment.

Electrical stimulation (ES) is one of the techniques used in urogynecological physiotherapy, which uses implanted or non-implanted electrodes. Intravaginal ES (IVES) is a conservative treatment option, described more than 40 years ago. IVES is used in patients with OAB and urge urinary incontinence (UUI), for detrusor inhibition. It has been suggested that IVES probably targets the detrusor muscle or pelvic floor muscle (PFM) or afferent innervation in UUI. According to the European Association Urology (EAU) Guidelines; in adults with urinary incontinence, ES may improve urinary incontinence compared to sham treatment. The IVES programs lasted between 4 weeks and 6 months in women with idiopathic OAB, although generally IVES was applied for 4-12 weeks. In most studies, IVES was applied 2-3 times a week, whereas in fewer studies it was applied more frequently. Despite that, no randomised studies compared different treatment frequencies in women with idiopathic OAB and thus, there is no evidence of which frequencies of treatment are the most effective ones. It should be kept in mind that different stimulation frequency may lead to different results. In addition, in the light of scientific evidence and our clinical experience, we think that this issue is still open for research. Better methodological quality studies are needed to obtain a higher level of scientific evidence and to know the optimal treatment frequency for OAB. Our study is the first prospective randomized controlled trial that compares the efficacy of IVES with different treatment frequency in women with idiopathic OAB. In this study, we aimed to assess the efficacy of 2 times and 5 times in a week IVES added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. The results of the our study will be of great benefit in deciding or preferring the treatment frequency and total treatment duration of IVES for the women with idiopathic OAB and their physicians.

Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.

A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002

Abstract Introduction: Urgency Urinary Incontinence (UUI) is a common condition with a prevalence of 9-31% in women in the United States. Despite current treatments, a high number of women have symptoms refractory to first- and second-line treatment approaches. Aims: The primary aim of this randomized controlled trial is to compare the efficacy of percutaneous tibial nerve stimulation (PTNS) and mirabegron treatment versus PTNS with placebo on change in the number of UUI episodes over a 12-week treatment course. Secondary aims include comparing the efficacy of combined treatment of PTNS and mirabegron versus PTNS with placebo on improvement in urinary incontinence symptom specific distress and quality of life related to UUI over a 12-week course of PTNS. Methods: A total of 54 consented participants will be recruited and randomized with 27 patients in the PTNS with mirabegron (daily 50 mg dose for the 12-week course) group and 27 patients in the PTNS with placebo group. Demographics and baseline data will be analyzed by student's t-test and chi-squared test or Fischer's Exact test as appropriate. Hypothesis: We anticipate that combination therapy will prove superior to monotherapy for reducing the number of UUI episodes over a 12-week treatment course.

The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg).

Tibial nerve stimulation (TNS) has been shown to be an effective alternative for the management of the overactive bladder (OAB). Transcutaneous Tibial Nerve Stimulation (TTNS) uses a series of regular electrical pulses to stimulate the tibial nerve. Numerous studies have positively shown the efficacy of this treatment. These studies have included multicentric, double-blind, randomized sham-controlled study of patients with idiopathic OAB. , . In 2013 the British National Institute for Health and Care Excellence (NICE) guidance has added TTNS as a second-line option for the management of female urinary incontinence , . In reality, the vast majority of patients treated using tibial nerve receive treatment percutaneously (PTNS) by inserting a needle into their lower leg. PTNS requires 12 visits to a physician's office and a painful treatment experience. From a physician's perspective PTNS is resource intensive in terms of time, financial and staff commitments. As a result, PTNS is often not a feasible option from the point of view of health care delivery. Moreover, the treatment may not be an option for patients whose schedule or ability to travel is limited. These issues are exacerbated for those with disabilities requiring special transport arrangements and who have trouble committing to 12 expensive and long trips to receive treatment. Additionally, 8% of patients who undergo PTNS complain of adverse effects which include pain, bruising, tingling or bleeding at the insertion site of the 34-gauge needle. As a direct result of these limitations long-term follow up studies of patients undergoing PTNS treatment show poor compliance to PTNS over time . Non-invasive, homecare TTNS devices such as the ZIDA Wearable Neuromodulation System are on the cusp of achieving regulatory clearance. TTNS, stimulates transcutaneously at a home-based setting and at least one study has explored the efficacy of this treatment method . Early results have demonstrated improvements in OAB symptom scores and urodynamic parameters . So far, these studies have employed standard commercial TENS devices (transcutaneous electrical nerve stimulation). These studies have used a variety of treatment frequencies to stimulate the tibial nerve at frequencies between 10 to 40 Hz, patient have been advised which pre-determined stimulation settings can be used for home care treatment. Commercial TENS devices limit mobility of patients during the time that the nerve is being stimulated.

This clinical trial compared the therapeutic effects and adverse events (AEs) in overactive bladder (OAB) patients receiving different combination of mirabegron and antimuscarinics. Methods: This is a prospective randomized study. OAB patients received mirabegron 25 mg (M25) daily for one month (1M) and then were randomized as group 1: to continue M25, group 2: to mirabegron 50 mg, group 3: to shift to solifenacin 5 mg (S5) and group 4: to combine M25 and S5 for further 2 months (totally 3 months, 3M). Efficacy and AEs were evaluated. At the end of 3M, the preferred option for future treatment was investigated.