Clinical Evaluation of Ajust™ in Stress Urinary Incontinence

NCT01290796 | Completed Results

• 1 other identifier: BMD-2112
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 6

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.

Conditions

Female Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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

• Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 12 Months

  Improvement was defined as a 25-point decrease (improvement) in Urinary Distress Inventory (UDI-6) score (Range: 0 - 100).

  12-months post procedure

Secondary Outcomes (9)

• Operative, Perioperative and Long-Term Complications During Operative Procedure

  1 day

• Operative, Perioperative and Long-Term Complications Perioperatively

  1-15 days

• Operative, Perioperative and Long-term Complications Through 36 Months

  Day 15 through 36-months post procedure

• Change in Post-operative Pain

  0-7 days

• Percentage of Subjects Who Showed Improvement in Self-reported SUI Symptoms at 36 Months

  0-36 Months

Study Arms (1)

Ajust Adjustable Single-Incision Sling

OTHER

Urinary incontinence sling

Device: Ajust Adjustable Single-Incision Sling

Interventions

Ajust Adjustable Single-Incision Sling 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.

Ajust Adjustable Single-Incision Sling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (6)

Clark Center for Urogynecology

Newport Beach, California, 92663, United States

Location

Female Pelvic & Urogynecology Institute of Michigan, Grand Rapids Womens Health

Grand Rapids, Michigan, 49503, United States

Location

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Institute for Female Pelvic Medicine and Reconstructive Surgery

Allentown, Pennsylvania, 18105, United States

Location

Manjon Gynecology

Harrisburg, Pennsylvania, 17110, United States

Location

Southern Uroynecology

West Columbia, South Carolina, 29169, United States

Location

Results Point of Contact

• Title: Jaime Ritter, MPH, CCRP, CIC
• Organization: Bard Medical Division

jaime.ritter@crbard.com

770-784-6437

Study Officials

• Vincent Lucente, MD

  Institute for Female Pelvic Medicine and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 7, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2015
• Last Updated: March 27, 2017
• Results First Posted: May 12, 2014

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)