Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
Solyx
A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women With Stress Urinary Incontinence
1 other identifier
interventional
281
2 countries
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
February 6, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2018
CompletedResults Posted
Study results publicly available
June 6, 2019
CompletedFebruary 10, 2021
January 1, 2021
4.6 years
February 4, 2013
April 17, 2019
January 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures
An assessment of improvement in stress urinary incontinence at 36 months, by a composite of objective (negative cough stress test with protocol required bladder fill procedure) and subjective measures (subject self reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I)). The PGI-I scale rates the patient's improvement or worsening of SUI symptoms relative to baseline. The scale is as follows: 1 - Very much better; 2 - Much better; 3 - A little better; 4 - No change' 5 - A little worse; 6 - Much worse; 7 - Very much worse, with the unit of measure being scores on a scale (lower scores indicate a more positive impression of change). Subjects met the definition of treatment success at 36 months if they had an answer of "No" to the item "Direct observation of urine loss with cough provocation" and an Improvement per the PGI-I (a response of "A little better", "Much better", or "Very much better").
Data presented is for 36 months
Study Arms (2)
Solyx Single Incision Sling System
ACTIVE COMPARATORSolyx Single Incision Sling System
Obtryx II Sling System
ACTIVE COMPARATORObtryx II Sling System
Interventions
Solyx Single Incision Sling System
Eligibility Criteria
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%
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Cedars Sinai Medical Center
Beverly Hills, California, 90211, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Scripps Clinic Carmel Valley
San Diego, California, 92130, United States
Norwalk Hospital
Norwalk, Connecticut, 06850, United States
Christiana Hospital
Newark, Delaware, 19713, United States
Physicians Regional Healthcare
Naples, Florida, 34105, United States
Cherokee Women's Health Specialist
Canton, Georgia, 30114, United States
Chesapeake Urology Research Associates
Hanover, Maryland, 21076, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28210, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
St Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Genesis Healthcare System
Zanesville, Ohio, 43701, United States
Center for Pelvic Health
Franklin, Tennessee, 37067, United States
University of Texas Southwestern
Austin, Texas, 78701, United States
University of Texas, Southwestern
Dallas, Texas, 75390, United States
Baylor University Medical Center
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Las Colinas OBGYN
Irving, Texas, 75062, United States
MacArthur OB/GYN Management, LLC
Irving, Texas, 75062, United States
Kyle P. McMorries, MD
Nacogdoches, Texas, 75965, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
Valley Medical Center
Covington, Washington, 98055, United States
Cabrini Medical Centre
Malvern, Australia
Related Publications (1)
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.
PMID: 33955778DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Teresa Takle-Flach
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda White, MD
University of Texas
- PRINCIPAL INVESTIGATOR
Joseph Schaffer, MD
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 6, 2013
Study Start
June 1, 2013
Primary Completion
January 17, 2018
Study Completion
January 17, 2018
Last Updated
February 10, 2021
Results First Posted
June 6, 2019
Record last verified: 2021-01