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

• ClinicalTrials.gov Identifier: NCT00460434
• Recruitment Status: Completed
• First Posted: April 16, 2007
• Results First Posted: September 11, 2017
• Last Update Posted: May 30, 2018
• Sponsor: NICHD Pelvic Floor Disorders Network
• 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): NICHD Pelvic Floor Disorders Network

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pelvic Organ Prolapse	Device: TVT; Other: Sham	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 337 participants
• 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
• Study Start Date: May 2007
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 :

1. 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.
2. 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.
3. 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).
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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:

Pelvic Floor Disorders Network 

Publications:

Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.

• Responsible Party: NICHD Pelvic Floor Disorders Network
• ClinicalTrials.gov Identifier: NCT00460434
• 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 Posted: April 16, 2007
• Results First Posted: September 11, 2017
• Last Update Posted: May 30, 2018
• Last Verified: April 2018

Keywords provided by NICHD Pelvic Floor Disorders Network:

Prolapse; Urinary incontinence; TVT

Additional relevant MeSH terms:

Uterine Prolapse; Prolapse; Pelvic Organ Prolapse; Pathological Conditions, Anatomical; Uterine Diseases