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Urinary Incontinence clinical trials

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NCT ID: NCT01048424 Completed - Clinical trials for Urinary Incontinence, Urge

Slow Paced-Respiration Intervention to Reduce Incontinence Trial (SPIRIT)

SPIRIT
Start date: January 2010
Phase: N/A
Study type: Interventional

Urgency incontinence is a common and burdensome problem in women. Current treatments for this condition, while effective, are associated with potentially disabling side effects and high rates of discontinuation. There is an urgent need for alternate treatments for urgency incontinence that are both clinically effective and well-tolerated by women in the community. RESPeRATE is a commercially available "walkman-like" device that measures chest/abdominal excursion during respiration using an elastic belt with a sensor placed around the torso over clothing. The device senses respiration and uses musical tones keyed to inhalation and exhalation to help the user slow respiration and prolong exhalation to a recommended goal of less than 10 breaths per minute. RESPeRATE is approved by the US Food and Drug Administration (FDA) for treatment of mild hypertension, and use of the device has also been shown to decrease self-reported anxiety and stress, oxygen consumption, and respiratory rate. Because anxiety and stress are strongly associated with urgency incontinence, and common behavioral strategies for managing incontinence emphasize relaxation and slow breathing at the time of an urgency episode, paced respiration may also be useful in treating urgency incontinence and/or decreasing its burden on quality of life. We propose to conduct a 6-week pilot randomized controlled trial of slow paced respiration using the RESPeRATE device among 30 women with urgency incontinence to assess the feasibility of recruiting and teaching women to use the RESPeRATE device as well as to gather preliminary data on the efficacy of slow paced respiration for treatment of urgency incontinence and related symptoms. Participants will complete a 7-day voiding diary and complete questionnaires to measure outcome.

NCT ID: NCT01042275 Completed - Clinical trials for Stress Urinary Incontinence

Patient-reported Outcome After Sling Insertion Using the Incontinence Outcome Questionnaire (IOQ)

Start date: March 2009
Phase:
Study type: Observational

Midurethral tapes are by now standard procedure in the surgical treatment of women with stress urinary incontinence. While the retropubic TVT is well documented with long-term results up to 11 years and continence rates of 90 %, the published data for the transoburator tapes (TO) cover follow-up of 3 years only. So far, all tapes establish continence effectively. Recently, the detailed 27-item Incontinence Outcome Questionnaire (IOQ) was constructed to assess patient-reported outcome and quality of life after insertion of a midurethral tape and validated for the German language. The aim of this study was to evaluate patient-reported mid- and long-term outcome after insertion of tension-free vaginal tape (TVT), transobturator sling, outside-in (TOT) and tension-free transobturator tape, inside-out (TVT-O).

NCT ID: NCT01042249 Completed - Stroke Clinical Trials

Pelvic Floor Muscle Training(PFMT) on Lower Urinary Tract Symptoms (LUTS) in Men With Stroke

Start date: February 2010
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of pelvic floor muscle training (PFMT) on Lower Urinary Tract Symptoms (LUTS) in men after stroke. 120 men with LUTS or increased LUTS after stroke is included and randomized into a treatment group or a control group. The subjects in the treatment group follows a 12 week standard PFMT program, while the control group is not given specific treatment of their LUTS but like the treatment group follows the standard rehabilitation program for stroke patient. Outcome are measured by - 5 questionnaires - Voiding diary - 24-hour pad test - pelvic floor muscle assessment test

NCT ID: NCT01042236 Completed - Clinical trials for Stress Urinary Incontinence

Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

Start date: January 2009
Phase: Phase 2
Study type: Interventional

The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence

NCT ID: NCT01036841 Completed - Enuresis Clinical Trials

Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation

TM
Start date: December 2009
Phase: Phase 4
Study type: Interventional

Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%, tablet 0.2%, MELT 0.5%). There 's insufficient evidence to confirm the actually used bioequivalent doses ( 10µg spray = 120µg MELT= 0.2mg tablet). Although so frequently used, very few pharmacokinetic and -dynamic data on desmopressin are available for children. Due to prolonged half life, associated with waterintoxication,the nasal spray has a black box warning from the FDA and is no longer recommended . For some authors oral formulations appear to be a safer alternative. However, based on clinical experience of less response rate with oral formulations, lower biodisponibility is suspected. Adult research confirms low bioavailability of tablets but also show major influences by food-intake and changes in gastro-intestinal motility. To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never is 3 hours between evening meal and bedtime. In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties for desmopressin Lyophilisate MELT formula. Since these results implicate superior action of MELT, often a change to MELT is recommended if there is a suboptimal response with tablet: sublingual absorption would eliminate the influence of food-intake. However, for this statement there's no evidence, since these tests were all conducted in children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT and tablet. Hypothesis is that desmopressin MELT formulation has a better bioavailability when administered together with meal due to its sublingual absorption.

NCT ID: NCT01032265 Completed - Clinical trials for Female Stress Urinary Incontinence

Web-based Management of Female Stress Urinary Incontinence

Start date: December 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.

NCT ID: NCT01008943 Completed - Clinical trials for Stress Urinary Incontinence

Autologous Cell Therapy for Female Stress Urinary Incontinence

Start date: June 2, 2010
Phase: Phase 2
Study type: Interventional

The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.

NCT ID: NCT00998790 Completed - Clinical trials for Stress Urinary Incontinence

A Post-Market Study of the AMS AdVanceā„¢ Male Sling System for the Treatment of Male Stress Urinary Incontinence

Start date: January 2007
Phase: N/A
Study type: Interventional

A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.

NCT ID: NCT00996489 Completed - Clinical trials for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency

This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence

Start date: January 8, 2008
Phase: N/A
Study type: Interventional

This is a post approval study of Coaptite® in the treatment of female urinary incontinence.

NCT ID: NCT00942370 Completed - Clinical trials for Stress Urinary Incontinence

Electromyographic (EMG) and Mechanomyographic (MMG) Comparison

EMG-MMG
Start date: July 2009
Phase: N/A
Study type: Observational

The purpose of this study is to assess the delay between the detection (by mechanomyography-MMG) of rectus abdominis contraction and the detection of cough in cough effort.