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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
281

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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