The Altis Single Incision Sling System for Female Stress Urinary Incontinence Study
This study is ongoing, but not recruiting participants.
Sponsor:
Coloplast A/S
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01272284
First received: January 5, 2011
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stress Urinary Incontinence |
Device: Altis Single Incision Sling System (SIS) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Altis Single Incision Sling System for Female Stress Urinary Incontinence Study |
Resource links provided by NLM:
Further study details as provided by Coloplast A/S:
Primary Outcome Measures:
- To assess improvement in subject incontinence via 24-hour pad weight as defined by a reduction in pad weight from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To characterize incontinence via cough stress test and subject voiding diary at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Assessment of device and procedure related adverse events in order to substantiate the safety and effectiveness [ Time Frame: post implant through 24 months ] [ Designated as safety issue: Yes ]
- To assess subject quality of life via validated questionnaires [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Questionnaires:
Urogenital Distress Inventory (UDI-6 SF) Incontinence Impact Questionnaire-Short Form (IIQ-7) Patient Global Impression of Improvement (PGI-I)
| Estimated Enrollment: | 113 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272284
Locations
| United States, California | |
| Tri Valley Urology | |
| Murrieta, California, United States, 92562 | |
| United States, Florida | |
| Urology Specialists, LLC | |
| Hialeah, Florida, United States, 33016 | |
| United States, Georgia | |
| Atlanta Medial Research Institute | |
| Alpharetta, Georgia, United States, 30005 | |
| United States, Idaho | |
| Rosemark Womencare Specialist | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| University of Chicago - Department of Urology | |
| Chicago, Illinois, United States, 60612 | |
| United States, Michigan | |
| Female Pelvic Medicine & Urogynecology Institute of Michigan | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Nebraska | |
| Bellevue ObGyn | |
| Bellevue, Nebraska, United States, 68123 | |
| United States, New Jersey | |
| Delaware Valley Urology | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, North Carolina | |
| Carolina Urology Partners | |
| Gastonia, North Carolina, United States, 28054 | |
| United States, Oklahoma | |
| The University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, South Carolina | |
| Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| Carolina Urologic Research Center | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Virginia | |
| Eastern Virginia Medical School | |
| Norfolk, Virginia, United States, 23507 | |
| The Group for Women | |
| Norfolk, Virginia, United States, 23502 | |
| Johnston Willis Medical Center | |
| Richmond, Virginia, United States, 23235 | |
| Canada, Quebec | |
| CHUS Hopital Fleurimont | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
Sponsors and Collaborators
Coloplast A/S
Investigators
| Principal Investigator: | Ervin Kocjancic, MD | University of Chicago, Chicago, IL, United States |
More Information
No publications provided
| Responsible Party: | Coloplast A/S |
| ClinicalTrials.gov Identifier: | NCT01272284 History of Changes |
| Other Study ID Numbers: | CP006SU |
| Study First Received: | January 5, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Coloplast A/S:
|
Female Stress urinary incontinence Mini sling Single incision sling Urinary incontinence Mixed urinary incontinence Additional relevant MeSH terms: Stress |
Urinary Incontinence Urinary Incontinence, Stress Pathological Processes Urination Disorders Urological Disorders Urological Manifestations Signs and Symptoms |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013