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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460434
First Posted: April 16, 2007
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Office of Research on Women's Health (ORWH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
dwallace, RTI International
  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 (SUI) 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 dwallace, RTI International:

Primary Outcome Measures:
  • Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence [ Time Frame: 3 months post-surgery ]
    Defined as a positive cough stress test, bothersome incontinence symptoms, or treatment for urinary incontinence, and urinary incontinence (stress, urge, or mixed), regardless of whether interim treatment for incontinence had been provided.

  • Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery [ Time Frame: 12 months post-surgery ]
    Defined as a positive cough stress test or report of bothersome incontinence symptoms.


Secondary Outcome Measures:
  • Medical Outcomes Study 36-Item Short Form Health Survey [ Time Frame: Baseline, 3 months, and 12 Months post-surgery ]
    This survey is a generic health-related quality of life measure. Scores have normalized values with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status. Results measure the average change in scores from baseline to follow-up.

  • Positive Cough Stress Test [ Time Frame: 3 and 12 Months Post-surgery ]
    A leakage of urine with coughing or straining in either the supine or standing position with the bladder filled through a urethral catheter to 300 ml.

  • Symptoms of Incontinence [ Time Frame: 3 and 12 Months Post-surgery ]
    Symptoms that were at least moderately bothersome to the participant (as measured by a response of "moderately" or "quite a bit" to any of the four items on the Pelvic Floor Distress Inventory regarding leakage).

  • Treatment for Incontinence [ Time Frame: 3 months post-surgery ]
    The need for treatment for any urinary incontinence, including surgery, medication, pessary for incontinence, supervised pelvic-muscle exercises, timed voiding and fluid management, periurethral injection, botulinum toxin injection, neuromodulation, or other treatment for incontinence.

  • Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) [ Time Frame: Baseline, 3 months, and 12 months post-surgery ]
    PFDI is a symptom inventory for pelvic floor disorders. Scores ranges from 0 to 300, with higher scores indicating more symptoms. Results measure the average change in scores from baseline to follow-up.

  • Urinary Distress Inventory (UDI) Obstructive Symptom Subscale [ Time Frame: Baseline, 3 months, and 12 months post-surgery ]
    Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.

  • Urinary Distress Inventory (UDI) Irritative Symptom Subscale [ Time Frame: Baseline, 3 months, and 12 months post-surgery ]
    Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.

  • Urinary Distress Inventory (UDI) Stress Subscale [ Time Frame: Baseline, 3 months, and 12 months post-surgery ]
    Scores on the UDI subscales range from 0 to 100, with higher score indicating more symptoms. Results measure the average change in scores from baseline to follow-up.

  • Incontinence Severity Index [ Time Frame: Baseline, 3 months, and 12 months post-surgery ]
    Scores on the Incontinence Severity Index range from 1 to 12, with higher scores indicating greater severity. Results measure average change in scores from baseline.


Enrollment: 337
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
Tension-free Vaginal Tape (TVT) surgery
Device: TVT
Prophylactic TVT
Sham Comparator: 2
Sham Tension-free Vaginal Tape (TVT) surgery
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 Pelvic Floor Distress Inventory (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 pelvic organ prolapse quantification (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Office of Research on Women's Health (ORWH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: John T Wei, MD University of Michigan
  More Information

Additional Information:
Publications:
Responsible Party: dwallace, Project Director, RTI International
ClinicalTrials.gov Identifier: NCT00460434     History of Changes
Other Study ID Numbers: 15P01
2U01HD041249 ( U.S. NIH Grant/Contract )
2U10HD041250 ( U.S. NIH Grant/Contract )
2U10HD041261 ( U.S. NIH Grant/Contract )
2U10HD041267 ( U.S. NIH Grant/Contract )
1U10HD054136 ( U.S. NIH Grant/Contract )
1U10HD054214 ( U.S. NIH Grant/Contract )
1U10HD054215 ( U.S. NIH Grant/Contract )
1U10HD054241 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2007
First Posted: April 16, 2007
Results First Submitted: April 18, 2017
Results First Posted: September 11, 2017
Last Update Posted: September 11, 2017
Last Verified: August 2017

Keywords provided by dwallace, RTI International:
Prolapse
Urinary incontinence
TVT

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female