Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

A Post-Market Evaluation of the Altis® Single Incision Sling System Versus Transobturator or Retropubic Mesh Sling in the Treatment of Female Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348112
• Other study ID #: SU020
• Status: Completed
• Start date: January 2015
• Est. completion date: September 2021

Study information

• Verified date: November 2023
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this postmarket study is to compare the safety and effectiveness of the Altis Single Incision Sling (SIS) to an FDA cleared transobturator and/or retropubic sling through 36 months.

Description:

This study is a prospective, post-market, multi-center, cohort assessment comparing Altis SIS (n=178) and transobturator and/or retropubic slings (n=178) in the treatment of stress urinary incontinence at up to 40 U.S. and international sites. Subjects will be followed for a total of 36 months with scheduled visits at 6, 12, 18, 24 and 36 months. The study population will consist of adult female subjects with stress urinary incontinence who are clinically indicated for surgical intervention with a mesh sling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject is female and at least 18 years of age.

• The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.

• The subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics.

• The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc.) for > 6 months.

Exclusion Criteria:

• The subject has an active urogenital infection or active skin infection in region of surgery.

• The subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading.

• The subject is having a concomitant pelvic floor procedure.

• The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).

• The subject had a prior surgical stress urinary incontinence (SUI) treatment.

• The subject has undergone radiation or brachy therapy to treat pelvic cancer.

• The subject has urge predominant incontinence by MESA assessment.

• The subject has an atonic bladder or post void residual (PVR) above 100 cc on = 2 occasions.

• The subject is pregnant and/or is planning to get pregnant in the future.

• The subject has a contraindication to the surgical procedure or the product Instructions for Use (IFU).

• The subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, without the sponsors approval.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Altis Single Incision Sling
Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
• Transobturator or Retropubic Sling
Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.

Locations

Country	Name	City	State
Canada	CHUS Hopital Fleurimont	Sherbrooke	Quebec
United States	Akron Urogynecology Associates	Akron	Ohio
United States	Albany Medical Center	Albany	New York
United States	The Institute for Female Pelvic Medicine and Reconstructive Surgery	Allentown	Pennsylvania
United States	Boston Urogynecology Associates	Cambridge	Massachusetts
United States	Associated Urologists of North Carolina	Cary	North Carolina
United States	Novant Health	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Pelvic Solutions Center	Denver	Colorado
United States	Women's Health Advantage	Fort Wayne	Indiana
United States	Carolina Urology Partners	Gastonia	North Carolina
United States	Female Pelvic Medicine & Urogynecology	Grand Rapids	Michigan
United States	FirstHealth Urogynecology	Hamlet	North Carolina
United States	Urology Specialists, LLC	Hialeah	Florida
United States	Rosemark Women Care Specialists	Idaho Falls	Idaho
United States	University of Nevada	Las Vegas	Nevada
United States	Institute of Female Pelvic Medicine & Reconstructive Surgery	North Wales	Pennsylvania
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Adult and Pediatric Urology & Urogynecology	Omaha	Nebraska
United States	Associated Urologists of North Carolina	Raleigh	North Carolina
United States	Sanford Health	Sioux Falls	South Dakota
United States	Baystate Health System	Springfield	Massachusetts
United States	Stanford University	Stanford	California
United States	The Group for Women	Virginia Beach	Virginia
United States	Lexington Urology	West Columbia	South Carolina
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina
United States	Genesis Healthcare	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	Observed effectiveness, defined as a reduction from baseline in 24 hour pad weight of at least 50% at 6 months.	6 months
Primary	Primary Safety Endpoint	Observed device and/or procedure-related serious adverse events through 36 months.	36 months