The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
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| ClinicalTrials.gov Identifier: NCT01272284 |
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Recruitment Status :
Completed
First Posted : January 7, 2011
Results First Posted : November 28, 2013
Last Update Posted : February 11, 2021
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Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stress Urinary Incontinence | Device: Altis® Single Incision Sling System (SIS) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 113 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | January 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Altis® SIS
Subjects enrolled with Altis® SIS
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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. |
Primary Outcome Measures :
- Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months [ Time Frame: 6 months (compared to baseline) ]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 [ Time Frame: 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 [ Time Frame: 6 months (compared to baseline) ]
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 [ Time Frame: 6 months (compared to baseline) ]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 [ Time Frame: 6 months (compared to baseline) ]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 [ Time Frame: 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 [ Time Frame: 12 months (compared to baseline) ]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 [ Time Frame: 12 months (compared to baseline) ]
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 [ Time Frame: 12 months (compared to baseline) ]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 [ Time Frame: 12 months (compared to baseline) ]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 [ Time Frame: 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).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272284
Locations
Show 17 study locations
Sponsors and Collaborators
Coloplast A/S
Investigators
| Principal Investigator: | Ervin Kocjancic, MD | University of Chicago, Chicago, IL, United States |
| Responsible Party: | Coloplast A/S |
| ClinicalTrials.gov Identifier: | NCT01272284 |
| Other Study ID Numbers: |
CP006SU |
| First Posted: | January 7, 2011 Key Record Dates |
| Results First Posted: | November 28, 2013 |
| Last Update Posted: | February 11, 2021 |
| Last Verified: | January 2021 |
Keywords provided by Coloplast A/S:
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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 |
Additional relevant MeSH terms:
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Urinary Incontinence Enuresis Urinary Incontinence, Stress Surgical Wound Urination Disorders Urologic Diseases |
Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders Wounds and Injuries |