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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784588
Recruitment Status : Completed
First Posted : February 6, 2013
Results First Posted : June 6, 2019
Last Update Posted : August 9, 2019
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Device: Solyx Single Incision Sling System Device: Obtryx II Sling System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : January 17, 2018
Actual Study Completion Date : January 17, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Solyx Single Incision Sling System
Solyx Single Incision Sling System
Device: Solyx Single Incision Sling System
Solyx Single Incision Sling System

Active Comparator: Obtryx II Sling System
Obtryx II Sling System
Device: Obtryx II Sling System
Standard outside-in transobturator sling

Primary Outcome Measures :
  1. Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures [ Time Frame: Data presented is for 36 months ]
    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").

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

Inclusion Criteria:

  1. Female ≥ 18 years of age
  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:

  1. Subjects who are pregnant, lactating, or planning future pregnancies
  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

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 identifier (NCT number): NCT01784588

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United States, California
Cedars Sinai Medical Center
Beverly Hills, California, United States, 90211
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Scripps Clinic Carmel Valley
San Diego, California, United States, 92130
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19713
United States, Florida
Physicians Regional Healthcare
Naples, Florida, United States, 34105
United States, Georgia
Cherokee Women's Health Specialist
Canton, Georgia, United States, 30114
United States, Maryland
Chesapeake Urology Research Associates
Hanover, Maryland, United States, 21076
United States, North Carolina
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28210
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
St Alexius Medical Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Genesis Healthcare System
Zanesville, Ohio, United States, 43701
United States, Tennessee
Center for Pelvic Health
Franklin, Tennessee, United States, 37067
United States, Texas
University of Texas Southwestern
Austin, Texas, United States, 78701
University of Texas, Southwestern
Dallas, Texas, United States, 75390
Baylor University Medical Center
Fort Worth, Texas, United States, 76104
Baylor College of Medicine
Houston, Texas, United States, 77030
Las Colinas OBGYN
Irving, Texas, United States, 75062
MacArthur OB/GYN Management, LLC
Irving, Texas, United States, 75062
Kyle P. McMorries, MD
Nacogdoches, Texas, United States, 75965
Permian Research Foundation
Odessa, Texas, United States, 79761
United States, Washington
Valley Medical Center
Covington, Washington, United States, 98055
Cabrini Medical Centre
Malvern, Australia
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Amanda White, MD University of Texas
Principal Investigator: Joseph Schaffer, MD University of Texas Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Study Protocol  [PDF] August 22, 2018
Statistical Analysis Plan  [PDF] February 21, 2017

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Responsible Party: Boston Scientific Corporation Identifier: NCT01784588     History of Changes
Other Study ID Numbers: U9915-Solyx
First Posted: February 6, 2013    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: August 9, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders