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Clinical Trial Summary

The purpose of this study is to assess the overall effectiveness of the Ajust Adjustable Single-Incision Sling in the surgical treatment of female stress urinary incontinence.


Clinical Trial Description

Urinary incontinence (UI), or the complaint of any involuntary loss of urine, ranges in severity from the occasional leaking urine during actions resulting in increased abdominal pressure (coughing, sneezing, laughing, exercise, etc.) to sudden, unpredictable strong urges to void. Female stress urinary incontinence (SUI) is attributed to a weakening of the pelvic floor muscles.

A recent review of literature describing the prevalence of UI calculated the median prevalence of female UI to be 27.6% (4.8-58.4%), with the prevalence of significant incontinence increasing with age. The prevalent cause of UI was further categorized into stress (50%), mixed (32%) and urge (14%).

Nonsurgical treatment of female SUI has traditionally been limited to alpha-adrenergic agonists and estrogens, pelvic floor exercises, biofeedback, electrical stimulation and behavior modification1. Options for surgical treatment consists of periurethral injections of bulking agents, transvaginal suspensions, retropubic suspensions, slings and sphincter prostheses.

The Ajust™ Adjustable Single-Incision Sling is a fully adjustable single-incision sling that anchors in the transobturator membranes, anatomically sufficient spaces for support of the urethra. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01290796
Study type Interventional
Source C. R. Bard
Contact
Status Completed
Phase N/A
Start date January 2011
Completion date October 2015

See also
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Completed NCT02023502 - Proteomic Pattern in Female Stress Urinary Incontinence: a Pilot Study
Completed NCT01848938 - Treatment of Stress Urinary Incontinence Via Smartphone N/A
Completed NCT01699425 - Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings. N/A
Completed NCT02418299 - Er:YAG Laser Treatment for Female Stress and Mixed Urinary Incontinence (IncontiLase) N/A
Completed NCT01094353 - A Comparative Study Minisling Versus Transobturator (TOT)Sling Phase 4
Completed NCT00910338 - Efficacy and Safety of Extracorporeal Biofeedback N/A
Recruiting NCT04131387 - The Safety and Efficacy of Micro-energy Ultrasound Therapy in the Treatment of Female Stress Urinary Incontinence N/A
Not yet recruiting NCT02981654 - Safety and Efficacy of Carbone Dioxide (CO2) Laser System in Treatment of Female Stress Urinary Incontinence. N/A
Completed NCT01032265 - Web-based Management of Female Stress Urinary Incontinence N/A