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Urinary Incontinence, Stress clinical trials

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NCT ID: NCT01500603 Terminated - Clinical trials for Stress Urinary Incontinence

Periurethral Pro-ACTTM Balloons vs Retrourethral AdvanceXP(TM) Male Sling for Post-prostatectomy Incontinence

BALLANCE
Start date: March 2013
Phase: N/A
Study type: Interventional

Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness. Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up. Primary objective: The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up. Secondary objectives: - Comprehensive comparative medical evaluation of the two devices in terms of efficacy - Complete evaluation of the side effects of the two techniques - Evaluation of the quality of life - Evaluation of patient satisfaction - Cost-effectiveness study of the device (total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system) Population: Patients with history of RP without cancer recurrence, presenting pure SUI on urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test < 300g). Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The total number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat. Medical evaluation: Main criterion:failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI. Secondary outcome criteria - pad usage per day - quantitative reduction of the 24hr-pad test - complications (infection, erosion, hematoma, acute urinary retention) - number of re-interventions or re-admissions during follow-up - quality of life measured by the ICIQ-SF questionnaire - patient satisfaction by the PGI-I questionnaire Economic evaluation: - Study of the total cost over one year in each case - Adjustment of cost of each device to quality of life (QALY evaluation) - Cost effectiveness study - Proposals will be made to state at which level the two devices should be covered by the healthcare system.

NCT ID: NCT01366066 Terminated - Clinical trials for Stress Urinary Incontinence

Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence

Start date: May 2011
Phase: Phase 3
Study type: Interventional

During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve Stimulation (TMNS) in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome. The present study aims to treat urinary incontinence and includes 2 groups of patients with 30 patients in each group: Women suffering from urinary stress incontinence and women suffering from urge incontinence. A medical vibrator is used and in each group the subjects will be randomized to vibration treatment or no vibration treatment. All patients will receive pelvic floor training and all women suffering from urge incontinence will receive anticholinergic medications. The stimulation will be performed at the perineum every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests. If the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing a normal function of the pelvic floor muscles and bladder function in incontinent patients.

NCT ID: NCT01358214 Terminated - Clinical trials for Urinary Incontinence, Stress

Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)

Start date: May 2011
Phase: N/A
Study type: Observational

Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.

NCT ID: NCT01337193 Terminated - Clinical trials for Stress Urinary Incontinence

Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence

Start date: February 2011
Phase: N/A
Study type: Interventional

The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence. The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback. All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.

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: NCT01029106 Terminated - Clinical trials for Stress Urinary Incontinence

Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)

Start date: September 2009
Phase: N/A
Study type: Observational

This is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a TVT SECUR operative procedure. The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, Intraoperative procedural data will be collected. Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. The anatomic position of the device will be characterize by transvaginal ultrasound testing. To determine the rate and/or improvement rate of patients who have received the Gynecare Secur device after 12 months and after 24 months.

NCT ID: NCT00743535 Terminated - Clinical trials for Stress Urinary Incontinence

Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach

Start date: February 2008
Phase: Phase 4
Study type: Interventional

The incidence of anterior pelvic defect in women is estimated about 10% and it may be often associated to urinary stress incontinence. To date the correction of anterior defects with the use of graft material inserted with transobturator approach has become of large use. Moreover, given the frequent association of urinary stress incontinence to anterior defect, in most of cases it becomes necessary to perform at the same time an anti-incontinence procedure, i.e. a sub-urethral sling positioning. Based on these considerations the aim of this trial will be to compare two different approach for sub-urethral sling positioning, transobturator and transvaginal tape (TOT and TVT) performed in association to transobturator correction of anterior defect with mesh in terms of efficacy and safety.

NCT ID: NCT00685217 Terminated - Clinical trials for Urinary Incontinence, Stress

Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

Start date: May 2008
Phase: Phase 3
Study type: Interventional

This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.

NCT ID: NCT00642109 Terminated - Clinical trials for Stress Urinary Incontinence

A Comparison of the Retropubic (TVT) With the Transobturator Sling Operation in the Treatment of Female Stress Urinary Incontinence or Stress Dominated Mixed Urinary Incontinence

Start date: January 2006
Phase: N/A
Study type: Interventional

The midurethral tension-free vaginal tape (a macroporous polypropylene mesh) procedure is a well established technique for treating female stress urinary incontinence in patients with (hyper)mobile urethra. Postoperative continence rates are achieved in up to 95%. Currently, several anatomical approaches are developed and investigated to simplify this minimal invasive technique and make it safer. While the retropubic approach consists of the passage of the needles from under the midurethra up behind the pubic bone through the cavum retzii, the transobturator technique traverses the foramina obturatoria. Intraoperative complications like bladder perforation (in 4%) can be treated conservatively, while postoperative complications like voiding dysfunction (urinary outlet obstruction in up to 16% or urinary retention) are troublesome, impair the quality of life and require occasionally surgical sling release (transection of the sling). The aim of this study is to compare quality of life, postoperative voiding dysfunction, success rates and tape position after retropubic and transobturator sling procedure. - Trial with surgical intervention

NCT ID: NCT00527696 Terminated - Clinical trials for Stress Urinary Incontinence

Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence

Start date: May 2008
Phase: Phase 3
Study type: Interventional

To compare the efficacy and complications of the TVT SECUR system (TVT S) and trans-vaginal obturator tape (TVT-O) procedures for the surgical management of female stress urinary incontinence.