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Stress Urinary Incontinence clinical trials

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NCT ID: NCT01583166 Completed - Clinical trials for Stress Urinary Incontinence

Voiding Function After Mid-Urethral Slings With and Without Local Anesthetic: Randomized Controlled Trial

URINE&ME
Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.

NCT ID: NCT01532583 Completed - Clinical trials for Stress Urinary Incontinence

The Outcome of the Transobturator Tape (TOT) Procedure

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

The aim of our study is to report the subjective and objective outcome of outside-in transobturator technique (TOT) (Monarc®) in long-term follow-up. This is a follow-up study concerning 191 patients operated on in Turku University Hospital between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a supine stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale (VAS), a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and short versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an absence of reoperation for SUI during the follow-up period.

NCT ID: NCT01505439 Completed - Clinical trials for Stress Urinary Incontinence

A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

Start date: June 2011
Phase: Phase 4
Study type: Interventional

This study is to investigate the effects of solifenacin on urgency urinary incontinence symptoms and incontinence quality-of-life (I-QoL) in female patients with clinically significant stress urinary incontinence accompanied by urgency urinary incontinence.

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: NCT01472068 Completed - Clinical trials for Stress Urinary Incontinence

A Pilot Study to Evaluate Safety and Performance of Neuromuscular Electrical Stimulation With the Inko RS Device for the Treatment of Stress Urinary Incontinence

Start date: December 2011
Phase: Phase 1
Study type: Interventional

This is a pilot clinical study taking place at one site in Berlin, Germany using Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of 20 women suffering from stress urinary incontinence. This involves a 12 week, 30 minute, 5 days out of 7 set treatment program with the device. After the 12 week treatment programme the subjects will be asked to perform daily set exercises for a further 14 weeks.

NCT ID: NCT01455779 Unknown status - Clinical trials for Stress Urinary Incontinence

Lyrette: Renewing Continence Objective and Subjective Efficacy Study

ROSE
Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the treatment efficacy of the Lyrette® System in women most likely to be treated in an office setting for the condition of stress urinary incontinence, secondary to urethral hypermobility.

NCT ID: NCT01445834 Completed - Clinical trials for Stress Urinary Incontinence

Age-stratified Outcome of Pelvic Floor Muscle Exercise for Urinary Incontinence

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

In this retrospective study the outcome of pelvic floor muscle training in 150 women will be tested regarding patients reported satisfaction and achievement of the incontinence improvement. Comparison of two age groups, controlled for BMI, parity and previous incontinence operations.

NCT ID: NCT01426048 Completed - Clinical trials for Stress Urinary Incontinence

Long-term Outcome of the TVT Procedure Without Preoperative Urodynamic Examination

Start date: November 2008
Phase: Phase 0
Study type: Observational

A follow-up study of 191 patients operated on with the TVT procedure between January 1998 and May 2000 at the Department of Obstetrics and Gynecology in the Turku City Hospital. After a mean of 10.5 years patients were invited to a follow-up visit. Subjective outcome was evaluated with condition-specific and general quality of life and health questionnaires. Objective outcome was evaluated with gynaecological examination and a supine stress test. Objective cure was defined as a negative stress test and no need for a reoperation for SUI and subjective cure.

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: NCT01355133 Completed - Clinical trials for Stress Urinary Incontinence

Safety and Efficacy Study of Intrasphincteric Autologous Myoblast Injection to Treat Stress Urinary Incontinence

Start date: August 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this pilot clinical study is to determine if intrasphincteric autologous myoblast injections in combination with electrical stimulation are safe and effective in treating stress urinary incontinence, confirming the optimal dose and assessing tolerability of the procedure.