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

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Solyx Single Incision Sling System
Obtryx II Sling System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars Sinai Medical Center
  • Loma Linda University Medical Center
  • Scripps Clinic Carmel Valley
  • Norwalk Hospital
  • Christiana Hospital
  • Physicians Regional Healthcare
  • Cherokee Women's Health Specialist
  • Chesapeake Urology Research Associates
  • Novant Health Presbyterian Medical Center
  • Lyndhurst Clinical Research
  • St Alexius Medical Center
  • Genesis Healthcare System
  • Center for Pelvic Health
  • University of Texas Southwestern
  • University of Texas, Southwestern
  • Baylor University Medical Center
  • Baylor College of Medicine
  • Las Colinas OBGYN
  • MacArthur OB/GYN Management, LLC
  • Kyle P. McMorries, MD
  • Permian Research Foundation
  • Valley Medical Center
  • Cabrini Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Solyx Single Incision Sling System

Obtryx II Sling System

Arm Description

Solyx Single Incision Sling System

Obtryx II Sling System

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

Full Information

First Posted
February 4, 2013
Last Updated
January 27, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01784588
Brief Title
Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
Acronym
Solyx
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 Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 17, 2018 (Actual)
Study Completion Date
January 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
281 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solyx Single Incision Sling System
Arm Type
Active Comparator
Arm Description
Solyx Single Incision Sling System
Arm Title
Obtryx II Sling System
Arm Type
Active Comparator
Arm Description
Obtryx II Sling System
Intervention Type
Device
Intervention Name(s)
Solyx Single Incision Sling System
Intervention Description
Solyx Single Incision Sling System
Intervention Type
Device
Intervention Name(s)
Obtryx II Sling System
Intervention Description
Standard outside-in transobturator sling
Primary Outcome Measure Information:
Title
Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures
Description
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").
Time Frame
Data presented is for 36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda White, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Schaffer, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Scripps Clinic Carmel Valley
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Physicians Regional Healthcare
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Facility Name
Cherokee Women's Health Specialist
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
St Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Genesis Healthcare System
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Center for Pelvic Health
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
University of Texas Southwestern
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
University of Texas, Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor University Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Las Colinas OBGYN
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
MacArthur OB/GYN Management, LLC
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Kyle P. McMorries, MD
City
Nacogdoches
State/Province
Texas
ZIP/Postal Code
75965
Country
United States
Facility Name
Permian Research Foundation
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Valley Medical Center
City
Covington
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Cabrini Medical Centre
City
Malvern
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
33955778
Citation
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.
Results Reference
derived

Learn more about this trial

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

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