Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

NCT00460434 | Completed Phase 2 Results DMC

• 9 other identifiers: 15P012U01HD0412492U10HD0412502U10HD0412612U10HD0412671U10HD0541361U10HD0542141U10HD0542151U10HD054241
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 8

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.

Conditions

Pelvic Organ Prolapse

Keywords

Prolapse; Urinary incontinence; TVT

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence

  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.

  3 months post-surgery

• Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery

  Defined as a positive cough stress test or report of bothersome incontinence symptoms.

  12 months post-surgery

Secondary Outcomes (9)

• Medical Outcomes Study 36-Item Short Form Health Survey

  Baseline, 3 months, and 12 Months post-surgery

• Positive Cough Stress Test

  3 and 12 Months Post-surgery

• Symptoms of Incontinence

  3 and 12 Months Post-surgery

• Treatment for Incontinence

  3 months post-surgery

• Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)

  Baseline, 3 months, and 12 months post-surgery

Study Arms (2)

1

EXPERIMENTAL

Tension-free Vaginal Tape (TVT) surgery

Device: TVT

2

SHAM COMPARATOR

Sham Tension-free Vaginal Tape (TVT) surgery

Other: Sham

Interventions

TVT DEVICE

Prophylactic TVT

1

Sham OTHER

Sham TVT

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• Office of Research on Women's Health (ORWH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (8)

The University of Alabama at Birmingham

Birmingham, Alabama, 35233-7333, United States

Location

USCD Medical Center

La Jolla, California, 92037, United States

Location

Kaiser Permanente

San Diego, California, 92120, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

UT Southwestern

Dallas, Texas, 35249, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

• 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.

  PMID: 22716974 BACKGROUND

• 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.

  PMID: 32769645 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse; Urinary Incontinence

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Marie Gantz
• Organization: RTI International

mgantz@rti.org

919-597-5110

Study Officials

• John T Wei, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 30, 2018
• Results First Posted: September 11, 2017

Record last verified: 2018-04

Locations

US (8)