Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)

C. R. Bard

Status

Completed

Conditions

Female Stress Urinary Incontinence

Treatments

Device: Ajust Adjustable Single-Incision Sling

Study type

Interventional

Funder types

Industry

Identifiers

NCT01290796

BMD-2112

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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