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

NCT01272284 | Completed Results

• 1 other identifier: CP006SU
• Study Type: interventional
• Target: 113
• Locations: 2 countries
• Sites: 17

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).

Conditions

Stress Urinary Incontinence

Keywords

Female; Stress urinary incontinence; Mini sling; Single incision sling; Urinary incontinence; Mixed urinary incontinence; Additional relevant MESH terms:; Stress; Urinary Incontinence, Stress; Pathological Processes; Urination Disorders; Urological Disorders; Urological Manifestations; Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months

  Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.

  6 months (compared to baseline)

Secondary Outcomes (10)

• Percentage of Participants With Negative Cough Stress Test at 6 Months

  6 months

• Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months

  6 months (compared to baseline)

• Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months

  6 months (compared to baseline)

• Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months

  6 months (compared to baseline)

• Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months

  6 months

Study Arms (1)

Altis® SIS

OTHER

Subjects enrolled with Altis® SIS

Device: Altis® Single Incision Sling System (SIS)

Interventions

Altis® Single Incision Sling System (SIS) 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.

Altis® SIS

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (17)

Tri Valley Urology

Murrieta, California, 92562, United States

Location

Urology Specialists, LLC

Hialeah, Florida, 33016, United States

Location

Atlanta Medial Research Institute

Alpharetta, Georgia, 30005, United States

Location

Rosemark Womencare Specialist

Idaho Falls, Idaho, 83404, United States

Location

University of Illinois at Chicago - Department of Urology

Chicago, Illinois, 60612, United States

Location

Illinois Urogynecology, LTD

Oak Lawn, Illinois, 60453, United States

Location

Female Pelvic Medicine & Urogynecology Institute of Michigan

Grand Rapids, Michigan, 49503, United States

Location

Bellevue ObGyn

Bellevue, Nebraska, 68123, United States

Location

Delaware Valley Urology

Voorhees Township, New Jersey, 08043, United States

Location

Carolina Urology Partners

Gastonia, North Carolina, 28054, United States

Location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

The Group for Women

Norfolk, Virginia, 23502, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Johnston Willis Medical Center

Richmond, Virginia, 23235, United States

Location

CHUS Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Pathologic Processes; Urination Disorders; Urologic Diseases; Urological Manifestations; Signs and Symptoms

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Coloplast Corp

usdibe@coloplast.com

612-302-4990

Study Officials

• Ervin Kocjancic, MD

  University of Chicago, Chicago, IL, United States

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: January 5, 2011
• First Posted: January 7, 2011
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2014
• Last Updated: February 11, 2021
• Results First Posted: November 28, 2013

Record last verified: 2021-01

Locations

CA (1); US (16)