Clinical trial NCT01272284: The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
Official title: The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months
timeFrame: 6 months (compared to baseline)
Secondary outcomes:
measure: Percentage of Participants With Negative Cough Stress Test at 6 Months
timeFrame: 6 months
measure: Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months
timeFrame: 6 months (compared to baseline)
measure: Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months
timeFrame: 6 months (compared to baseline)
measure: Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months
timeFrame: 6 months (compared to baseline)
measure: Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months
timeFrame: 6 months
measure: Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months
timeFrame: 12 months (compared to baseline)
measure: Percentage of Participants With Negative Cough Stress Test at 12 Months
timeFrame: 12 months (compared to baseline)
measure: Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months
timeFrame: 12 months (compared to baseline)
measure: Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months
timeFrame: 12 months (compared to baseline)
measure: Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Murrieta
country: United States
facility: Tri Valley Urology
state: California
city: Hialeah
country: United States
facility: Urology Specialists, LLC
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medial Research Institute
state: Georgia
city: Idaho Falls
country: United States
facility: Rosemark Womencare Specialist
state: Idaho
city: Chicago
country: United States
facility: University of Illinois at Chicago - Department of Urology
state: Illinois
city: Oak Lawn
country: United States
facility: Illinois Urogynecology, LTD
state: Illinois
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology Institute of Michigan
state: Michigan
city: Bellevue
country: United States
facility: Bellevue ObGyn
state: Nebraska
city: Voorhees
country: United States
facility: Delaware Valley Urology
state: New Jersey
city: Gastonia
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Norfolk
country: United States
facility: The Group for Women
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: Johnston Willis Medical Center
state: Virginia
city: Sherbrooke
country: Canada
facility: CHUS Hopital Fleurimont
state: Quebec
Study officials:
affiliation: University of Chicago, Chicago, IL, United States
name: Ervin Kocjancic, MD
role: PRINCIPAL_INVESTIGATOR
References: