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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Altis® Single Incision Sling System (SIS)
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tri Valley Urology
  • Urology Specialists, LLC
  • Atlanta Medial Research Institute
  • Rosemark Womencare Specialist
  • University of Illinois at Chicago - Department of Urology
  • Illinois Urogynecology, LTD
  • Female Pelvic Medicine & Urogynecology Institute of Michigan
  • Bellevue ObGyn
  • Delaware Valley Urology
  • Carolina Urology Partners
  • The University of Oklahoma Health Sciences Center
  • Greenville Hospital System
  • Carolina Urologic Research Center
  • The Group for Women
  • Eastern Virginia Medical School
  • Johnston Willis Medical Center
  • CHUS Hopital Fleurimont

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Altis® SIS

Arm Description

Subjects enrolled with Altis® SIS

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.
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.
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%.
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%.
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).
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.
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.
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)
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)
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).

Full Information

First Posted
January 5, 2011
Last Updated
January 25, 2021
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01272284
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Altis® SIS
Arm Type
Other
Arm Description
Subjects enrolled with Altis® SIS
Intervention Type
Device
Intervention Name(s)
Altis® Single Incision Sling System (SIS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months
Description
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%.
Time Frame
6 months (compared to baseline)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Negative Cough Stress Test at 6 Months
Description
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.
Time Frame
6 months
Title
Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months
Description
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.
Time Frame
6 months (compared to baseline)
Title
Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months
Description
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%.
Time Frame
6 months (compared to baseline)
Title
Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months
Description
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%.
Time Frame
6 months (compared to baseline)
Title
Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months
Description
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).
Time Frame
6 months
Title
Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months
Description
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.
Time Frame
12 months (compared to baseline)
Title
Percentage of Participants With Negative Cough Stress Test at 12 Months
Description
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.
Time Frame
12 months (compared to baseline)
Title
Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months
Description
Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Urinary Distress Inventory Short Form (UDI-6)
Time Frame
12 months (compared to baseline)
Title
Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months
Description
Success defined as at least a 50% improvement from baseline to 12 months, as measured by validated Incontinence Impact Questionnaire Short Form (IIQ-7)
Time Frame
12 months (compared to baseline)
Title
Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months
Description
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).
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ervin Kocjancic, MD
Organizational Affiliation
University of Chicago, Chicago, IL, United States
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri Valley Urology
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Urology Specialists, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Atlanta Medial Research Institute
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Rosemark Womencare Specialist
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Illinois at Chicago - Department of Urology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Urogynecology, LTD
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Female Pelvic Medicine & Urogynecology Institute of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Bellevue ObGyn
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Delaware Valley Urology
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Carolina Urology Partners
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
The Group for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Johnston Willis Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
CHUS Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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