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

Boston Scientific

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: Solyx Single Incision Sling System; Device: Obtryx II Sling System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01784588

U9915-Solyx

Details and patient eligibility

About

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.

Enrollment: 281 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

281 participants in 2 patient groups

Solyx Single Incision Sling System

Active Comparator group

Description:

Solyx Single Incision Sling System

Treatment:

Device: Solyx Single Incision Sling System

Obtryx II Sling System

Active Comparator group

Description:

Obtryx II Sling System

Treatment:

Device: Obtryx II Sling System