Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

Female Stress Urinary Incontinence Clinical Trial

— CEASe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290796
• Other study ID #: BMD-2112
• Status: Completed
• Phase: N/A
• First received: February 4, 2011
• Last updated: November 23, 2015
• Start date: January 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Free of Stress Urinary Incontinence	Percentage of patients who are free of stress urinary incontinence, as assessed by a negative (-) Cough Stress Test (CST) and no surgical retreatment, at the 12 month study visit.	12-months post surgical procedure	No
Primary	Percentage of Patients Who Showed Improvement in Self-reported SUI Symptoms	Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).	12-months post procedure	No
Secondary	Operative, Perioperative and Long-term Complications		Day 0 through 36-months post procedure	Yes