Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

Completed · Not applicable

Conditions studied: Female Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT01290796

Run by

C. R. Bard

People needed

153

Starts

2011-01-01

Expected to finish

2015-10-01

Last updated by the study team

2017-03-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female, age at least 18 years
• Have signed an Informed Consent Form
• Has been diagnosed with stress urinary incontinence as documented by: a minimum 30-degree urethral deflection, considered to be a candidate for transobturator repair by consulting surgeon (investigator), has a positive CST
• Desires surgical correction of SUI using the Ajust™ Adjustable Single-Incision Sling

You may not qualify if…

• Patient is actively participating in any other genitourinary clinical trial of an experimental drug or device
• Patient is known to be pregnant or desiring future childbearing
• Patient has a known urinary tract infection, or known infection in the operative field at the time of device implantation
• Patient is unable to have their anticoagulation therapy suspended for the completion of the surgical procedure
• Patient requires concurrent correction of pelvic organ prolapse
• Patient has a history of previous sling procedure
• Patient has known history of detrusor overactivity demonstrated by urodynamics
• Patient has known urinary retention
• Patient has a current genitourinary fistula or urinary diverticulum
• Patient has a prior history of pelvic radiation
• Patient has a MESA urge symptom score (% of total possible urge score) that is greater than their MESA stress symptom score (% of total possible stress score)
• Any condition in the opinion of the Investigator that would preclude the use of the Ajust™ Adjustable Single-Incision Sling, or preclude the subject from completing the follow-up requirements

Where it is running

• Clark Center for Urogynecology — Newport Beach, California, United States
• Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health — Grand Rapids, Michigan, United States
• Princeton Urogynecology — Princeton, New Jersey, United States
• Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown, Pennsylvania, United States
• Manjon Gynecology — Harrisburg, Pennsylvania, United States
• Southern Uroynecology — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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