Trial record 2 of 18 for:    pelvic floor disorders | NICHD [Lead]

Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial (OPUS)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
dwallace, RTI International
ClinicalTrials.gov Identifier:
NCT00460434
First received: April 13, 2007
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT) at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.


Condition Intervention Phase
Pelvic Organ Prolapse
Device: TVT
Other: Sham
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial

Resource links provided by NLM:


Further study details as provided by NICHD Pelvic Floor Disorders Network:

Primary Outcome Measures:
  • The failure rate at 3 months defined as subsequent treatment for urinary incontinence, signs or symptoms of bothersome urinary incontinence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Prevalence of bothersome urinary incontinence at 12 months following index surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Difference in total cost of care in relation to differences in Health-Related Quality Of Life (HRQOL) and health utilities at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in anterior vaginal prolapse [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Lower urinary tract symptoms [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • HRQOL [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: 3 and 12 months ] [ Designated as safety issue: Yes ]
  • Risks factors for postoperative outcomes including SUI, urinary retention and adjuvant treatment for SUI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Examine adaptive behaviors used for pelvic floor disorders following prolapse surgery. [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 517
Study Start Date: May 2007
Study Completion Date: March 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TVT
Device: TVT
Prophylactic TVT
Sham Comparator: 2
Sham TVT
Other: Sham
Sham TVT

Detailed Description:

The overall objective of this randomized clinical trial is to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding TVT® at the time of the prolapse surgery among women with anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence.

The primary aims are:

In stress continent women planning vaginal surgery for pelvic organ prolapse:

  1. To determine if the failure rate defined by subsequent treatment for urinary incontinence, signs or symptoms of bothersome urinary incontinence (defined as having at least moderate bother for any of 4 PFDI incontinence items) differs between vaginal prolapse repair and vaginal prolapse repair plus TVT® during the first 3 months after the index surgery.
  2. To determine if the prevalence of bothersome urinary incontinence at 12 months after the index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus TVT®, whether or not there was subsequent treatment for symptoms of urinary incontinence; i.e., to determine whether symptom-specific treatment of incontinence after prolapse surgery is equally effective to prophylactic treatment by adding a TVT® at the time of the prolapse surgery.
  3. To measure the total cost of care and relate the difference in cost of care between the two groups to differences in health utilities and health-related quality of life, which will allow us to examine the cost-effectiveness of prophylactic use of a TVT® at the time of prolapse surgery versus symptom-specific treatment of stress incontinence after prolapse surgery.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:

  • Do you usually have a sensation of bulging or protrusion from the vaginal area?
  • Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by POP-Q Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm) Surgical plan that includes a vaginal approach for apical or anterior prolapse repair Able and willing to complete data collection per protocol, including written informed consent

Exclusion Criteria:

Pregnancy or planning pregnancy in the first postoperative year Any prior mid urethral sling Currently participating in another interventional study for urinary incontinence Untreated urinary tract infection (may be included after resolution)

Overt symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items:

  • Do you usually experience urine leakage related to coughing, sneezing, or laughing?
  • Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?
  • Do you usually experience urine leakage related to lifting or bending over? Currently being treated for stress urinary incontinence with pessary/incontinence ring, pelvic floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).
  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: NCT00460434

Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233-7333
United States, California
USCD Medical Center
La Jolla, California, United States, 92037
Kaiser Permanente
San Diego, California, United States, 92120
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
UT Southwestern
Dallas, Texas, United States, 35249
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
NICHD Pelvic Floor Disorders Network
Investigators
Principal Investigator: John T Wei, MD University of Michigan
  More Information

Additional Information:
Publications:
Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Joseph Schaffer J, Meikle SF, and Spino C for the Pelvic Floor Disorders Network. (2012) A Midurethral Sling to Reduce Incontinence after Vaginal Prolapse Repair. N Engl J Med;366:2358-67

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dwallace, Project Director, RTI International
ClinicalTrials.gov Identifier: NCT00460434     History of Changes
Other Study ID Numbers: 15P01, 2U01HD041249, 2U10HD041250, 2U10HD041261, 2U10HD041267, 1U10HD054136, 1U10HD054214, 1U10HD054215, 1U10HD054241
Study First Received: April 13, 2007
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Pelvic Floor Disorders Network:
Prolapse
Urinary incontinence
TVT

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014