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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01784588
First received: February 4, 2013
Last updated: April 13, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Stress Urinary Incontinence
Device: Solyx Single Incision Sling System
Device: Obtryx II Sling System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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: negative cough stress test and a subject self-reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I).


Estimated Enrollment: 280
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Solyx Single Incision Sling System
Solyx Single Incision Sling System
Device: Solyx Single Incision Sling System
Solyx Single Incision Sling System
Active Comparator: Obtryx II Sling System
Obtryx II Sling System
Device: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784588

  Show 27 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01784588     History of Changes
Other Study ID Numbers: U9915-Solyx
Study First Received: February 4, 2013
Last Updated: April 13, 2014
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014