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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272284
• Other study ID #: CP006SU
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2021
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: January 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Surgical Wound
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	CHUS Hopital Fleurimont	Sherbrooke	Quebec
United States	Atlanta Medial Research Institute	Alpharetta	Georgia
United States	Bellevue ObGyn	Bellevue	Nebraska
United States	University of Illinois at Chicago - Department of Urology	Chicago	Illinois
United States	Carolina Urology Partners	Gastonia	North Carolina
United States	Female Pelvic Medicine & Urogynecology Institute of Michigan	Grand Rapids	Michigan
United States	Greenville Hospital System	Greenville	South Carolina
United States	Urology Specialists, LLC	Hialeah	Florida
United States	Rosemark Womencare Specialist	Idaho Falls	Idaho
United States	Tri Valley Urology	Murrieta	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	The Group for Women	Norfolk	Virginia
United States	Illinois Urogynecology, LTD	Oak Lawn	Illinois
United States	The University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Johnston Willis Medical Center	Richmond	Virginia
United States	Delaware Valley Urology	Voorhees	New Jersey

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	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	Percentage of Participants With Negative Cough Stress Test at 6 Months	Endpoint defined as a negative result at 6 months, as measured by the Cough Stress Test (CST), in which the percent of subjects with a negative CST is compared to a performance goal of 66%.; The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test.	6 months
Secondary	Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months	Endpoint defined as at least a 50% improvement from baseline to 6-months, as measured by 3-Day Voiding Diary, in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.; Subjects completed a 3-Day Voiding Diary of controlled urinations and the number and amount of leaks experienced.	6 months (compared to baseline)
Secondary	Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months	Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.	6 months (compared to baseline)
Secondary	Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months	Endpoint defined as at least a 50% improvement from baseline to 6 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7), in which the percent of subjects with at least a 50% improvement from baseline to 6 months is compared to a performance goal of 50%.	6 months (compared to baseline)
Secondary	Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months	Success defined as a response of "Very Much Better" or "Much Better" at 6 months, as measured by validated Patient Global Impression of Improvement (PGI-I).	6 months
Secondary	Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months	Success is defined as at least a 50% reduction in 24-hour pad weight from baseline to 12 months using the 24 hour pad weight test.	12 months (compared to baseline)
Secondary	Percentage of Participants With Negative Cough Stress Test at 12 Months	Success defined as a negative result at 12 months, as measured by the Cough Stress Test (CST).; The cough stress test was completed with the subject in the lithotomy and standing positions, filling bladder to maximum capacity with normal saline. The subject was then asked to cough 10 times and any leakage from the urethra was considered a positive test.	12 months (compared to baseline)
Secondary	Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months	Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)	12 months (compared to baseline)
Secondary	Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months	Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)	12 months (compared to baseline)
Secondary	Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months	Success defined as a response of "Very Much Better" or "Much Better" at 12 months, as measured by validated Patient Global Impression of Improvement (PGI-I).	12 months