Clinical trial NCT01290796: Clinical Evaluation of Ajust™ in Stress Urinary Incontinence
Official title: Clinical Evaluation of Ajust™ in Stress Urinary Incontinence (CEASe)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Stress Urinary Incontinence
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Free of Stress Urinary Incontinence
timeFrame: 12-months post surgical procedure
measure: Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months
timeFrame: 12-months post procedure
Secondary outcomes:
measure: Operative, Perioperative and Long-Term Complications During Operative Procedure
timeFrame: 1 day
measure: Operative, Perioperative and Long-Term Complications Perioperatively
timeFrame: 1-15 days
measure: Operative, Perioperative and Long-term Complications Through 36 Months
timeFrame: Day 15 through 36-months post procedure
measure: Change in Post-operative Pain
timeFrame: 0-7 days
measure: Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months
timeFrame: 0-36 Months
measure: Change in Incontinent Impact Questionnaire at 12 Months
timeFrame: 0-12 months
measure: Change in Incontinent Impact Questionnaire at 36 Months
timeFrame: 0-36 months
measure: Percentage of Patients With Impression of Improvement With Procedure at 12 Months
timeFrame: 0-12 Months
measure: Percentage of Patients With Impression of Improvement With Procedure at 36 Months
timeFrame: 0-36 Months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Clark Center for Urogynecology
state: California
city: Grand Rapids
country: United States
facility: Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health
state: Michigan
city: Princeton
country: United States
facility: Princeton Urogynecology
state: New Jersey
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Harrisburg
country: United States
facility: Manjon Gynecology
state: Pennsylvania
city: West Columbia
country: United States
facility: Southern Uroynecology
state: South Carolina
Study officials:
affiliation: Institute for Female Pelvic Medicine and Reconstructive Surgery
name: Vincent Lucente, MD
role: PRINCIPAL_INVESTIGATOR
References: