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

January 27, 2021 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Solyx Single Incision Sling System
Device: Solyx Single Incision Sling System
Solyx Single Incision Sling System
ACTIVE_COMPARATOR: Obtryx II Sling System
Device: Obtryx II Sling System
Standard outside-in transobturator sling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
Data presented is for 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Amanda White, MD, University of Texas
  • Principal Investigator: Joseph Schaffer, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

January 17, 2018

Study Completion (ACTUAL)

January 17, 2018

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (ESTIMATE)

February 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U9915-Solyx

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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