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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Solyx Single Incision Sling System
* Device: Obtryx II Sling System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Solyx Single Incision Sling System<br>Solyx Single Incision Sling System | Device: Solyx Single Incision Sling System<br>* Solyx Single Incision Sling System<br>|
| Active Comparator: Obtryx II Sling System<br>Obtryx II Sling System | Device: Obtryx II Sling System<br>* Standard outside-in transobturator sling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |