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Urinary Incontinence, Stress clinical trials

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NCT ID: NCT01284244 Recruiting - Clinical trials for Stress Urinary Incontinence

A Randomized Controlled Trial of the Uresta Continence Pessary

SURE
Start date: January 2011
Phase: Phase 2
Study type: Interventional

Stress urinary incontinence (SUI) is defined as the involuntary loss of urine with an increase in abdominal pressure, caused either by a loss of support under the bladder neck, or intrinsic urethral sphincter deficiency. It is a common problem in women that can significantly impact quality of life, with up to 30% developing SUI at some point in their lifetime. The most commonly utilized treatments for SUI include either pelvic floor (Kegel) exercises, or surgery. Many women find Kegel exercises unsatisfactory, but are reluctant to undergo a surgical procedure. Also, women who are poor candidates for surgery have limited options if Kegel exercises are unsuccessful. Over the years, there have been numerous attempts to develop effective non-surgical alternatives for treating SUI, but the results have been variable and the available data on efficacy limited. A new intravaginal incontinence pessary (Uresta) has been developed for treating stress incontinence, and is currently available in Canada via a medical distributor. The self-positioning device is initially fitted by a healthcare provider, but then can subsequently placed by the patient as needed. Uresta is designed to be easily inserted into the vagina and spontaneously fall into position, providing support beneath the urethra. A single, uncontrolled study of 21 women showed that Uresta significantly reduces urinary incontinence measures, with no reported complications. Using questionnaires, a 47% reduction in self-reported SUI symptoms was demonstrated. Pad weight following a pad test, an objective assessment of urine loss, showed a 50% reduction in leakage. This trial is intended to be a short-term assessment of the efficacy of the Uresta device, using a placebo arm in order to remove any of the possible sources of patient biases. The placebo ("sham") group will be obtained by placing a flexible silastic ring (inactivated Estring) high in the vagina where it will not alter urethral forces. The aim is to unequivocally determine whether the Uresta device provides the necessary urethral support to stop urine leakage from stress incontinence. The hypothesis is that the Uresta device will significantly reduce urinary losses from baseline, shown as a significant reduction pad weight following a pad test with the device in place.

NCT ID: NCT01272284 Completed - Clinical trials for Stress Urinary Incontinence

The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

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

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).

NCT ID: NCT01230450 Completed - Clinical trials for Female Stress Incontinence

Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress

SITOT
Start date: November 2009
Phase: Phase 1
Study type: Interventional

Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).

NCT ID: NCT01227447 Recruiting - Clinical trials for Incontinence, Overactive Bladder, Stress Urinary Incontinence

Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Human Urinary Outflow Tract

Start date: January 2010
Phase: N/A
Study type: Observational

The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet.

NCT ID: NCT01194999 Completed - Clinical trials for Urinary Bladder, Overactive

Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

Start date: October 2010
Phase: Phase 4
Study type: Interventional

Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Other overactive bladder (OAB) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however, suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be alleviated by said procedure. It is our aim to investigate this relationship in our clinic. As a prospective member of this study, you will be asked to complete five surveys. The first survey will be administered prior to your pubovaginal sling. This will be used to establish your baseline experience of OAB. Over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.

NCT ID: NCT01170728 Terminated - Clinical trials for Stress Urinary Incontinence

Virtue® Male Sling Fixation Study

Start date: July 2010
Phase: N/A
Study type: Observational

This study is a multi-center study that will assess the efficacy and safety of suture fixation of the Virtue® Male Sling.

NCT ID: NCT01148290 Completed - Clinical trials for Urinary Incontinence, Stress

Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence

Start date: May 2009
Phase: Phase 3
Study type: Interventional

The surgical treatment of vulvar cancer is characterized by a radical approach as standard, often associated to an important rate of functional complications. This surgery often includes the partial excision of urethra, resulting in a reduction of urethral closure pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral mobility. As consequence women treated for vulvar cancer may develop urinary incontinence. The incidence of this complication has been differently reported, but seems to reach the 100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence and no clear indication may be given at regards. Based on these considerations the aim of this trial will be to compare tension free vaginal tape and bulking agent injection in women with urinary stress incontinence developed after radical surgery for vulvar cancer.

NCT ID: NCT01137539 Completed - Clinical trials for Urinary Incontinence

TVT-SECUR as an Office-based Procedure

TVTSOffice
Start date: October 2008
Phase: N/A
Study type: Interventional

This is a pilot study to assess the feasibility and success of performing the TVT-Secur in the office setting. Endpoints would be success, complications, and patient and physician acceptance of the procedure. Success would be assessed by validated questionnaires. This is a prospective single arm study of 20 patients who will have the TVT-Secur procedure done in the office under local anesthesia. They will be followed for a period of 1 year.

NCT ID: NCT01123135 Withdrawn - Clinical trials for Stress Urinary Incontinence

The Effect of Vaginal Estrogen Cream on Subjective and Objective Symptoms of Urodynamic Stress Incontinence

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

This is a randomized, double blinded placebo controlled trial over a period of 3 months. Study subjects will be randomized into 2 groups: Those receiving drug (1gm of estrogen vaginal cream [EVC] at bed time 3 times a week), and those receiving placebo.

NCT ID: NCT01123096 Completed - Clinical trials for Stress Urinary Incontinence

Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?

Start date: September 2007
Phase: N/A
Study type: Observational

The purpose of this research study is to identify if the cough stress test is equal to the 24hour pad test in assessing stress urinary incontinence.