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Urinary Bladder, Underactive clinical trials

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NCT ID: NCT04236596 Completed - Urinary Retention Clinical Trials

Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

Start date: September 14, 2020
Phase: N/A
Study type: Interventional

This study is to map the pudendal nerve. In this study the researchers will examine subjects who are already receiving an implanted stimulator at their pudendal nerve as part of their normal clinical care.

NCT ID: NCT04184752 Completed - Voiding Disorders Clinical Trials

Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Without Cystocele

Start date: April 1, 1996
Phase:
Study type: Observational

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). The treatment strategies are different between DU and BOO. In general, urodynamic/videourodynamic studies are important for differential diagnosis. However, urodynamic/videourodynamic studies are invasive. The investigators are interested in whether there were specific symptoms or measurements that can be used for initial differential diagnosis between DU and BOO. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the clinical and urodynamic differences between the DU, BOO and non-DU/BOO groups.

NCT ID: NCT04184128 Completed - Cystocele Clinical Trials

Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele

Start date: November 1, 2010
Phase:
Study type: Observational

Women with cystocele may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). However, the impact of cystocele repair on the rates of DU and BOO remained obscure. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the impact of cystocele repair on the rates of DU and BOO.

NCT ID: NCT04161183 Completed - Clinical trials for Detrusor Underactivity

Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive Bladder (DU/UAB)

Start date: October 15, 2019
Phase: N/A
Study type: Interventional

To evaluate the efficacy and safety of ESWT for the treatment of patients with DU/UAB

NCT ID: NCT04000763 Recruiting - Urinary Retention Clinical Trials

Superficial Peroneal Nerve Neuromodulation for Non-Obstructive Urinary Retention

Start date: December 20, 2019
Phase: N/A
Study type: Interventional

Millions of Americans are suffering from underactive bladder (UAB). The impact of severe UAB, i.e. non-obstructive urinary retention (NOUR) on quality of life is significant because current treatment for non-obstructive urinary retention requires intermittent self-catheterization or an indwelling suprapubic catheter. Currently an effective drug for non-obstructive urinary retention does not exist. It is a therapeutic challenge for clinicians to successfully treat non-obstructive urinary retention. Sacral neuromodulation has been approved by the FDA since 1999 to treat non-obstructive urinary retention. It achieves >50% improvement in bladder emptying (reducing the frequency of self-catheterization or increasing voided volume) in just over half of the patients. Sacral neuromodulation requires surgical implantation of a stimulator and a lead with 4 electrodes. The surgery and implant are invasive and expensive, preventing a broad application of this effective therapy to many non-obstructive urinary retention patients. The goal of this study is to develop a novel non-invasive neuromodulation therapy for non-obstructive urinary retention as an alternative. Specifically, the investigators will explore the possibility to translate into humans a recent discovery in cats of an excitatory reflex from the superficial peroneal nerve to the bladder to treat non-obstructive urinary retention. Therefore, in this study the investigators propose to develop a non-invasive, transcutaneous neuromodulation therapy for non-obstructive urinary retention that can be administered at home.

NCT ID: NCT03702777 Completed - Underactive Bladder Clinical Trials

A Study of ASP8302 in Participants With Underactive Bladder

Start date: November 20, 2018
Phase: Phase 2
Study type: Interventional

The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in participants with UAB, to investigate the pharmacokinetics of ASP8302 in participants with UAB and to support the development of the UAB - Patient Reported Outcome (PRO).

NCT ID: NCT03175029 Completed - Overactive Bladder Clinical Trials

Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.

Start date: August 1, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.

NCT ID: NCT02463448 Completed - Clinical trials for Urinary Incontinence

Autologous Muscle Derived Cells for Underactive Bladder

Start date: November 16, 2016
Phase: Phase 1
Study type: Interventional

This is a prospective, open-label, Phase 1, single center study evaluating the safety and efficacy of Autologous Muscle Derived Cells as a treatment for chronic Underactive Bladder.

NCT ID: NCT02193451 Active, not recruiting - Clinical trials for Lower Urinary Tract Symptoms

Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods

UPSTREAM
Start date: April 2014
Phase: N/A
Study type: Interventional

Background and study aims: The prostate gland sits around the exit of the bladder in men. As men get older, the prostate grows, and this can narrow the exit from the bladder, so that there is restriction of flow. As a result, some men develop difficulty passing urine (voiding) as they age. For these men, prostate surgery can be helpful by removing the part of the prostate causing the narrowing, so that flow improves. However, for some men, almost identical symptoms of difficulty passing urine are due to underactive bladder. In other words, the bladder contraction is too weak, and is not effective at expelling the urine. This is a smaller group, but important, as these men may have no improvement after prostate surgery, while being exposed to risk of complications of surgery. Medical assessment of men with voiding problems typically involves discussing the symptoms, doing a physical examination of the prostate and measuring the urine flow rate. In many NHS hospitals, these are the only tests done before deciding whether to proceed to prostate surgery. In effect, voiding symptoms are presumed to be a result of prostate enlargement for these men, since it is the more common problem compared with bladder underactivity. However, this approach cannot identify which men actually have bladder underactivity as the cause of their voiding symptoms. So, in some hospitals an extra test is used, called urodynamics. Urodynamics is done to measure how much pressure the bladder generates when passing urine, because a high pressure shows the problem is obstruction, and a low pressure shows it is bladder weakness. Urodynamics involves gently putting a small tube into the bladder via the penis to measure the bladder pressure, and to fill the bladder with a sterile fluid (saline). Another small tube is gently placed into the rectum, via the anus, to measure abdominal pressures. Measuring abdominal pressure is necessary because any change in abdominal pressure can affect bladder pressure, and if the test did not allow for this it could give a misleading result. Urodynamics is safe, but some men find it uncomfortable or undignified, and a few develop urine infection afterwards. No studies have been conducted so far to tell us which of these two approaches to assessing men with voiding urinary problems is better overall. UPSTREAM consists of two phases: "UPSTREAM - Phase I" was a pragmatic, two-arm, multicentre, randomised controlled trial (RCT) to determine the clinical and cost-effectiveness of invasive urodynamics (UDS) for the diagnosis and management of bladder outlet obstruction in men. Men from 26 urology departments of NHS Hospitals in England who had bothersome lower urinary tract symptoms (LUTS) and were seeking further treatment, which may have included surgery, were randomised to one of two study arms; 'Routine Care' (as per the NICE diagnostic pathway), or routine care plus UDS ('Urodynamics'), which is currently optional. The design was utilised to establish noninferiority in symptom severity (International Prostate Symptom Score [IPSS]) 18-months post-randomisation. The primary outcome was IPSS at 18-months post-randomisation, and a key secondary outcome was the influence of UDS on rates of bladder outlet surgery. The RCT started 01 April 2014 and ended 30 September 2018. In 2018, we were awarded an extension to conduct a further (long term) follow up of UPSTREAM participants, five years post-randomisation; "UPSTREAM - Phase II". We aim to identify: the symptom outcomes of treatment; definitive surgery rates in the two study arms; and the long-term impact of LUTS and its therapy. The focus will continue to be on effectiveness and patient outcomes as per the original commissioning brief. "UPSTREAM - Phase II" started 01 July 2019 and has a planned end date of 30 June 2022.