Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence

In brief

The purpose of this research study is to compare the treatment device (Solyx) to a different mesh sling or control device (Obtryx II) for the treatment of symptoms for Stress Urinary Incontinence (SUI). Safety information and patient outcomes will be collected for three (3) years and evaluated.

Key facts

Study ID

NCT01784588

Run by

Boston Scientific Corporation

People needed

281

Starts

2013-06-01

Expected to finish

2018-01-17

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female ≥ 18 years of age
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study (subject or legal representative)
• Diagnosed with predominant SUI confirmed by positive cough stress test during the protocol required bladder fill procedure (see manual of operations)
• Confirmed SUI is greater than urge incontinence with the Medical Epidemiologic Social Aspect (MESA) questionnaire
• Cystometric capacity ≥ 300 cc
• Post-void residual (PVR) of ≤ 150 cc
• Medically approved for general, regional or monitored anesthesia

You may not qualify if…

• Subjects who are pregnant, lactating, or planning future pregnancies
• Subjects with a chief complaint of overactive bladder
• 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
• 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
• Subjects with prior pelvic organ prolapse surgery who experienced mesh complications
• Subjects with previous radiation therapy to the pelvis
• Subjects with known or suspected hypersensitivity to polypropylene mesh
• Subjects with any of the following confounding conditions:
• Neurogenic bladder
• Urethral stricture and bladder neck contracture
• Bladder stones or tumors
• Urinary tract fistula or diverticula
• Pathology which would compromise implant placement including subjects currently taking anticoagulation therapy
• Pathology that would limit blood supply or infections that would compromise healing including chemotherapy, systemic steroids and systemic immunosuppressants
• Subjects with diabetes and an A1c ≥ 7%
• Non-English speaking subjects
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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