This trial is active, not recruiting.

Condition female stress urinary incontinence
Treatment ajust adjustable single-incision sling
Sponsor C. R. Bard
Start date January 2011
End date June 2013
Trial size 153 participants
Trial identifier NCT01290796, BMD-2112


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Urinary incontinence sling
ajust adjustable single-incision sling
The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.

Primary Outcomes

Percentage of Patients Free of Stress Urinary Incontinence
time frame: 12-months post surgical procedure
Percentage of Patients Who Showed Improvement in Self-reported SUI Symptoms
time frame: 12-months post procedure

Secondary Outcomes

Operative, Perioperative and Long-term Complications
time frame: Day 0 through 36-months post procedure

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)
Principal investigator Vincent Lucente, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by C. R. Bard.