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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: Solyx Single Incision Sling System; Device: Obtryx II Sling System

• Registration Number: NCT01784588
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-06
• Study Start: 2013-06
• Primary Completion: 2018-01-17
• Study Completion: 2018-01-17
• Results First Submitted: 2019-04-17
• Results First Submitted QC: 2019-06-04
• Results First Posted: 2019-06-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 281

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solyx Single Incision Sling System	Solyx Single Incision Sling System	Solyx Single Incision Sling System
Obtryx II Sling System	Obtryx II Sling System	Obtryx II Sling System

Primary Outcome Measures

Name	Time	Method
Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures	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").

Trial Locations

Locations (23)

Cherokee Women's Health Specialist; 🇺🇸 Canton, Georgia, United States

Physicians Regional Healthcare; 🇺🇸 Naples, Florida, United States

Novant Health Presbyterian Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Chesapeake Urology Research Associates; 🇺🇸 Hanover, Maryland, United States

Genesis Healthcare System; 🇺🇸 Zanesville, Ohio, United States

MacArthur OB/GYN Management, LLC; 🇺🇸 Irving, Texas, United States

Baylor University Medical Center; 🇺🇸 Fort Worth, Texas, United States

Center for Pelvic Health; 🇺🇸 Franklin, Tennessee, United States

Las Colinas OBGYN; 🇺🇸 Irving, Texas, United States

Valley Medical Center; 🇺🇸 Covington, Washington, United States

Kyle P. McMorries, MD; 🇺🇸 Nacogdoches, Texas, United States

Cabrini Medical Centre; 🇦🇺 Malvern, Australia

Permian Research Foundation; 🇺🇸 Odessa, Texas, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Scripps Clinic Carmel Valley; 🇺🇸 San Diego, California, United States

Norwalk Hospital; 🇺🇸 Norwalk, Connecticut, United States

St Alexius Medical Center; 🇺🇸 Bismarck, North Dakota, United States

University of Texas, Southwestern; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Christiana Hospital; 🇺🇸 Newark, Delaware, United States

Cedars Sinai Medical Center; 🇺🇸 Beverly Hills, California, United States

University of Texas Southwestern; 🇺🇸 Austin, Texas, United States

Lyndhurst Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States