Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
NCT ID: NCT01784588
Last Updated: 2021-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
281 participants
INTERVENTIONAL
2013-06-30
2018-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Solyx Single Incision Sling System
Solyx Single Incision Sling System
Solyx Single Incision Sling System
Solyx Single Incision Sling System
Obtryx II Sling System
Obtryx II Sling System
Obtryx II Sling System
Standard outside-in transobturator sling
Interventions
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Solyx Single Incision Sling System
Solyx Single Incision Sling System
Obtryx II Sling System
Standard outside-in transobturator sling
Eligibility Criteria
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Inclusion Criteria
2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study (subject or legal representative)
3. Diagnosed with predominant SUI confirmed by positive cough stress test during the protocol required bladder fill procedure (see manual of operations)
4. Confirmed SUI is greater than urge incontinence with the Medical Epidemiologic Social Aspect (MESA) questionnaire
5. Cystometric capacity ≥ 300 cc
6. Post-void residual (PVR) of ≤ 150 cc
7. Medically approved for general, regional or monitored anesthesia
Exclusion Criteria
2. Subjects with a chief complaint of overactive bladder
3. Subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2 culture-proven urinary tract infections during a 6-month period prior to surgery or ≥ 3 in a 12-month period
4. Subjects with previous surgical procedures for SUI including bulking, urethral sling, bone anchor, Burch procedure, pubo-vaginal sling, and Marshall-Marchetti-Krantz (MMK) procedure. Excluding Kelly plication, Botox, anterior repair, or Inter-Stim
5. Subjects with prior pelvic organ prolapse surgery who experienced mesh complications
6. Subjects with previous radiation therapy to the pelvis
7. Subjects with known or suspected hypersensitivity to polypropylene mesh
8. Subjects with any of the following confounding conditions:
1. Neurogenic bladder
2. Urethral stricture and bladder neck contracture
3. Bladder stones or tumors
4. Urinary tract fistula or diverticula
5. Pathology which would compromise implant placement including subjects currently taking anticoagulation therapy
6. Pathology that would limit blood supply or infections that would compromise healing including chemotherapy, systemic steroids and systemic immunosuppressants
9. Subjects with diabetes and an A1c ≥ 7%
10. Non-English speaking subjects
11. Subjects who have participated in an investigational study (medical device or drug) within 30 days of study entry that may impact analysis of this device or have previously participated in the current study
18 Years
FEMALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Amanda White, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Joseph Schaffer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Cedars Sinai Medical Center
Beverly Hills, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Scripps Clinic Carmel Valley
San Diego, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Physicians Regional Healthcare
Naples, Florida, United States
Cherokee Women's Health Specialist
Canton, Georgia, United States
Chesapeake Urology Research Associates
Hanover, Maryland, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
St Alexius Medical Center
Bismarck, North Dakota, United States
Genesis Healthcare System
Zanesville, Ohio, United States
Center for Pelvic Health
Franklin, Tennessee, United States
University of Texas Southwestern
Austin, Texas, United States
University of Texas, Southwestern
Dallas, Texas, United States
Baylor University Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Las Colinas OBGYN
Irving, Texas, United States
MacArthur OB/GYN Management, LLC
Irving, Texas, United States
Kyle P. McMorries, MD
Nacogdoches, Texas, United States
Permian Research Foundation
Odessa, Texas, United States
Valley Medical Center
Covington, Washington, United States
Cabrini Medical Centre
Malvern, , Australia
Countries
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References
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White AB, Anger JT, Eilber K, Kahn BS, Gonzalez RR, Rosamilia A. Female Sexual Function following Sling Surgery: A Prospective Parallel Cohort, Multi-Center Study of the Solyx Single Incision Sling System versus the Obtryx II Sling System. J Urol. 2021 Sep;206(3):696-705. doi: 10.1097/JU.0000000000001830. Epub 2021 May 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U9915-Solyx
Identifier Type: -
Identifier Source: org_study_id
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