Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

NCT ID: NCT01290796

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Female Stress Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ajust Adjustable Single-Incision Sling

Urinary incontinence sling

Group Type: OTHER

Ajust Adjustable Single-Incision Sling

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Lucente, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Female Pelvic Medicine and Reconstructive Surgery

Locations

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

Countries

United States

Other Identifiers

BMD-2112

Identifier Type: -

Identifier Source: org_study_id