Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial - Full Text View

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Office of Research on Women's Health (ORWH)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00460434

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
Pelvic Organ Prolapse	Device: TVT Other: Sham

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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 ]

Estimated Enrollment:	350
Study Start Date:	May 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TVT	Device: TVT Prophylactic TVT
2: Sham Comparator 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:

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.
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.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460434

Locations

United States, Alabama
The University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35233-7333
Contact: Velria Willis, Rn, BSN 205-975-8522 vwillis@uabmc.edu
Contact: Holly E Richter, PhD, MD 205-934-7874 hrichter@uabmc.edu
Principal Investigator: Holly Richter, MD, PhD
United States, California
Kaiser Permanente	Recruiting
San Diego, California, United States, 92120
Contact: Giselle Zazueta-Damian 619-528-7914 giselle.Zazueta-Damian@kp.org
Contact: Shawn A. Menefee, MD 619-528-6149 Shawn.A.Menefee@kp.org
Principal Investigator: Shawn A. Menefee, MD
USCD Medical Center	Recruiting
La Jolla, California, United States, 92037
Contact: Lysa Woodall 858-657-6827 lwoodall@ucsd.edu
Contact: Charles W. Nager, MD 858-657-8640 cnager@ucsd.edu
Principal Investigator: Charles W. Nager, MD
United States, Illinois
Loyola University Medical Center	Recruiting
Maywood, Illinois, United States, 60153
Contact: Kathy Marchese, RN 708-216-2492 kmarche@lumc.edu
Contact: Linda Brubaker, MD 708-216-2170 Lbrubaker@lumc.edu
Principal Investigator: Linda Brubaker, MD
United States, North Carolina
Duke University	Recruiting
Durham, North Carolina, United States, 27710
Contact: Mary Loomis 919-660-9777 mary.loomis@duke.edu
Contact: Anthony Visco, MD 919-684-4647 anthony.visco@duke.edu
Principal Investigator: Anthony Visco, MD
United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Linda McElrath, RN 216-444-5505 mcelrathl@ccf.org
Contact: Matthew Barber, MD 216-445-0439 Barberm2@ccf.org
Principal Investigator: Matthew Barber, MD
United States, Texas
UT Southwestern	Recruiting
Dallas, Texas, United States, 35249
Contact: Kelly Moore, RN 214-648-3245 kelly.moore@UTSouthwestern.edu
Contact: Joseph Schaffer, MD 214-648-7211 Joseph.Schaffer@UTSouthwestern.edu
Principal Investigator: Joseph Schaffer, MD
United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Linda Freedman, BSN, RN 801-581-7038 linda.freedman@hsc.utah.edu
Contact: Ingrid E. Nygaard, MD 801-581-5750 Ingrid.nygaard@hsc.utah.edu
Principal Investigator: Ingrid E. Nygaard, MD

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Office of Research on Women's Health (ORWH)

Investigators

Principal Investigator:

John T Wei, MD

University of Michigan

More Information

Pelvic Floor Disorders Network This link exits the ClinicalTrials.gov site

Responsible Party:	NICHD ( Susan Meikle, Project Scientist )
Study ID Numbers:	15P01, 2U01 HD41249, 2U10 HD41250, 2U10 HD41261, 2U10 HD41267, 1U10 HD54136, 1U10 HD54214, 1U10 HD54215, 1U10 HD54241
Study First Received:	April 13, 2007
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00460434
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Prolapse
Urinary incontinence
TVT

Study placed in the following topic categories:

Genital Diseases, Female
Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Uterine Prolapse
Uterine Diseases

Urinary Incontinence
Intestinal Diseases
Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on January 16, 2009