Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Treatments solyx single incision sling system, obtryx ii sling system
Sponsor Boston Scientific Corporation
Start date June 2013
End date December 2017
Trial size 280 participants
Trial identifier NCT01784588, U9915-Solyx

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 SUI. Safety information and patient outcomes will be collected for three (3) years and evaluated.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Solyx Single Incision Sling System
solyx single incision sling system
Solyx Single Incision Sling System
(Active Comparator)
Obtryx II Sling System
obtryx ii sling system
to compare a single incision midurethral sling to a standard outside-in transobturator sling for the treatment of female stress urinary incontinence.

Primary Outcomes

Measure
The primary endpoint is an assessment of improvement in stress urinary incontinence at 36 months as compared to Baseline, by a composite of objective and subjective measures.
time frame: 36 months

Eligibility Criteria

Female participants at least 18 years old.

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 MESA 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 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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.