The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

NCT ID: NCT01272284

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-01-31

Brief Summary

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).

Detailed Description

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI). Primary Objective: Improvement in continence measured by 24 hour pad weight test with at least a 50% reduction in weight from baseline at 6 months. Secondary Objectives: Cough stress test results at 6 months; Subject QoL as measured by validated questionnaires: PGI-I, improvements in UDI-6 and IIQ-7 scores from baseline at 6 months, 3 day voiding diary improvement from baseline at 6 months; Device and procedure related adverse events. Brief Entrance Criteria: Adult female with confirmed SUI through cough stress test or urodynamics; Failed two non-invasive incontinence therapies; No prior surgical SUI treatment; No prolapse POP-Q Stage 2 or higher; No concurrent pelvic floor procedure; No urge predominant incontinence; No incontinence due to neurological disorder/disease; No PVR > 100cc; and, No contraindication to the surgical procedure. Study visits will take place at baseline, implant/hospitalization, 3 months, 6 months, 1 year, and 2 years post operatively. This study will enroll up to 113 subjects at up to 17 investigative sites in the US and Internationally.

Conditions

Stress Urinary Incontinence

Study Design

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

Study Groups

Altis® SIS

Subjects enrolled with Altis® SIS

Group Type: OTHER

Altis® Single Incision Sling System (SIS)

Intervention Type: DEVICE

The Altis® SIS is a permanently implantable synthetic sling for females placed at the mid-urethra to provide a scaffold for tissue in-growth and support for stress urinary incontinence.

Interventions

Altis® Single Incision Sling System (SIS)

The Altis® SIS is a permanently implantable synthetic sling for females placed at the mid-urethra to provide a scaffold for tissue in-growth and support for stress urinary incontinence.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is female at least 18 years of age
• Subject is able and willing to complete all procedures and follow-up visits indicated in this protocol
• 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

• Subject has an active urogenital infection or active skin infection in region of surgery
• Subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading
• Subject is having a concomitant pelvic floor procedure
• 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)
• Subject had a prior surgical SUI treatment
• Subject has undergone radiation or brachy therapy to treat pelvic cancer
• Subject has urge predominant incontinence
• Subject has an atonic bladder or a post void residual (PVR) consistently about 100cc
• Subject is pregnant and/or is planning to get pregnant in the future
• Subject has a contraindication to the surgical procedure or the Altis Instructions For Use (IFU)
• Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval

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

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ervin Kocjancic, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago, Chicago, IL, United States

Locations

Tri Valley Urology

Murrieta, California, United States

Urology Specialists, LLC

Hialeah, Florida, United States

Atlanta Medial Research Institute

Alpharetta, Georgia, United States

Rosemark Womencare Specialist

Idaho Falls, Idaho, United States

University of Illinois at Chicago - Department of Urology

Chicago, Illinois, United States

Illinois Urogynecology, LTD

Oak Lawn, Illinois, United States

Female Pelvic Medicine & Urogynecology Institute of Michigan

Grand Rapids, Michigan, United States

Bellevue ObGyn

Bellevue, Nebraska, United States

Delaware Valley Urology

Voorhees Township, New Jersey, United States

Carolina Urology Partners

Gastonia, North Carolina, United States

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Greenville Hospital System

Greenville, South Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

The Group for Women

Norfolk, Virginia, United States

Eastern Virginia Medical School

Norfolk, Virginia, United States

Johnston Willis Medical Center

Richmond, Virginia, United States

CHUS Hopital Fleurimont

Sherbrooke, Quebec, Canada

Countries

United States; Canada

Other Identifiers

CP006SU

Identifier Type: -

Identifier Source: org_study_id