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

Stress Urinary Incontinence Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784588
• Other study ID #: U9915-Solyx
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: January 17, 2018

Study information

• Verified date: January 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: January 17, 2018
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Solyx Single Incision Sling System
Solyx Single Incision Sling System
• Obtryx II Sling System
Standard outside-in transobturator sling

Locations

Country	Name	City	State
Australia	Cabrini Medical Centre	Malvern
United States	University of Texas Southwestern	Austin	Texas
United States	Cedars Sinai Medical Center	Beverly Hills	California
United States	St Alexius Medical Center	Bismarck	North Dakota
United States	Cherokee Women's Health Specialist	Canton	Georgia
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Valley Medical Center	Covington	Washington
United States	University of Texas, Southwestern	Dallas	Texas
United States	Baylor University Medical Center	Fort Worth	Texas
United States	Center for Pelvic Health	Franklin	Tennessee
United States	Chesapeake Urology Research Associates	Hanover	Maryland
United States	Baylor College of Medicine	Houston	Texas
United States	Las Colinas OBGYN	Irving	Texas
United States	MacArthur OB/GYN Management, LLC	Irving	Texas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Kyle P. McMorries, MD	Nacogdoches	Texas
United States	Physicians Regional Healthcare	Naples	Florida
United States	Christiana Hospital	Newark	Delaware
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Permian Research Foundation	Odessa	Texas
United States	Scripps Clinic Carmel Valley	San Diego	California
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina
United States	Genesis Healthcare System	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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").	Data presented is for 36 months