Clinical trial NCT00460434: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial
Official title: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pelvic Organ Prolapse
Keywords: Prolapse
Urinary incontinence
TVT
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
Collaborators: name: Office of Research on Women's Health (ORWH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2007-04-16
Enrollment: 337
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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).

Primary outcomes:
measure: Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence
timeFrame: 3 months post-surgery
measure: Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Medical Outcomes Study 36-Item Short Form Health Survey
timeFrame: Baseline, 3 months, and 12 Months post-surgery
measure: Positive Cough Stress Test
timeFrame: 3 and 12 Months Post-surgery
measure: Symptoms of Incontinence
timeFrame: 3 and 12 Months Post-surgery
measure: Treatment for Incontinence
timeFrame: 3 months post-surgery
measure: Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)
timeFrame: Baseline, 3 months, and 12 months post-surgery
measure: Urinary Distress Inventory (UDI) Obstructive Symptom Subscale
timeFrame: Baseline, 3 months, and 12 months post-surgery
measure: Urinary Distress Inventory (UDI) Irritative Symptom Subscale
timeFrame: Baseline, 3 months, and 12 months post-surgery
measure: Urinary Distress Inventory (UDI) Stress Subscale
timeFrame: Baseline, 3 months, and 12 months post-surgery
measure: Incontinence Severity Index
timeFrame: Baseline, 3 months, and 12 months post-surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: USCD Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Michigan
name: John T Wei, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.