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

This study is not yet open for participant recruitment.
Verified February 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01784588
First received: February 4, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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: to compare a single incision midurethral sling to a standard outside-in transobturator sling for the treatment of female stress urinary incontinence.

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:

U.S. FDA Resources

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: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Solyx Single Incision Sling System
Solyx Single Incision Sling System
 Device: to compare a single incision midurethral sling to a standard outside-in transobturator sling for the treatment of female stress urinary incontinence.
Obtryx II Sling System
Obtryx II Sling System
 Device: 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 urodynamic testing at 300 mL bladder volume in the sitting or standing position
  4. Confirmed SUI is greater than urge incontinence with MESA
  5. Documented SUI including hypermobility ≥ 30 degrees as measured by cotton swab testing during straining or coughing
  6. Negative urine culture at baseline; not pattern of recurrent urinary tract infections, defined as ≥ 2 culture-proven urinary tract infections during a 6-month period prior to surgery
  7. Cystometric capacity ≥ 250 mL
  8. Post-void residual (PVR) of equal to or less than 20% of functional bladder capacity or ≤ 100 mL
  9. Medically approved for general, regional or monitored anesthesia

Exclusion Criteria:

  1. Subjects who are pregnant, lactating, or planning future pregnancies
  2. Subjects with detrusor over activity (overactive bladder) representing the subject's major complaint
  3. Subjects with prior surgical urinary incontinence procedures
  4. Subjects with prior pelvic organ prolapse surgery who experienced mesh complications
  5. Subjects with previous radiation therapy to the pelvis
  6. Subjects with known or suspected hypersensitivity to polypropylene mesh
  7. Subjects with abnormal bladder capacity (<250 mL)

  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. Chronic cystitis
    5. Urinary tract fistula or diverticula
    6. Pathology which would compromise implant placement
    7. Pathology that would limit blood supply or infections that would compromise healing
  9. Non-English speaking subjects
  10. 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
No Contacts or Locations Provided
  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: February 4, 2013
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
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013