Clinical trial NCT01784588: Post Market Study Of Single Incision Sling Versus Transobturator Sling for Stress Urinary Incontinence
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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-02-06
Enrollment: 281
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures
timeFrame: Data presented is for 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: San Diego
country: United States
facility: Scripps Clinic Carmel Valley
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Naples
country: United States
facility: Physicians Regional Healthcare
state: Florida
city: Canton
country: United States
facility: Cherokee Women's Health Specialist
state: Georgia
city: Hanover
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Bismarck
country: United States
facility: St Alexius Medical Center
state: North Dakota
city: Zanesville
country: United States
facility: Genesis Healthcare System
state: Ohio
city: Franklin
country: United States
facility: Center for Pelvic Health
state: Tennessee
city: Austin
country: United States
facility: University of Texas Southwestern
state: Texas
city: Dallas
country: United States
facility: University of Texas, Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Irving
country: United States
facility: Las Colinas OBGYN
state: Texas
city: Irving
country: United States
facility: MacArthur OB/GYN Management, LLC
state: Texas
city: Nacogdoches
country: United States
facility: Kyle P. McMorries, MD
state: Texas
city: Odessa
country: United States
facility: Permian Research Foundation
state: Texas
city: Covington
country: United States
facility: Valley Medical Center
state: Washington
city: Malvern
country: Australia
facility: Cabrini Medical Centre
Study officials:
affiliation: University of Texas
name: Amanda White, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Joseph Schaffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.