Phase 2 N=337 Randomized Double-blind Prevention

Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

Pelvic Organ Prolapse

Bottom Line

View on ClinicalTrials.gov: NCT00460434 ↗

Enrolled (actual)

337

Serious AEs

14.2%

Results posted

Sep 2017

Primary outcome: Primary: Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence — 39; 85 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: TVT (Device); Sham (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: NICHD Pelvic Floor Disorders Network
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Failure Defined as Subsequent Treatment for Urinary Incontinence, Signs or Symptoms of Bothersome Urinary Incontinence	39; 85	—
PRIMARY Prevalence of Bothersome Urinary Incontinence at 12 Months Following Index Surgery	45; 74	—
SECONDARY Medical Outcomes Study 36-Item Short Form Health Survey	1.5; 0.6; 2.1; 1.5; 1.9; 2.0	—
SECONDARY Positive Cough Stress Test	10; 54; 5; 31	—
SECONDARY Symptoms of Incontinence	15; 41; 18; 30	—
SECONDARY Treatment for Incontinence	11; 13	—
SECONDARY Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI)	-44.9; -34.4; -43.1; -39.3	—
SECONDARY Urinary Distress Inventory (UDI) Obstructive Symptom Subscale	-27.3; -28.0; -26.4; -27.1	—
SECONDARY Urinary Distress Inventory (UDI) Irritative Symptom Subscale	-12.5; -10.5; -10.9; -11.6	—
SECONDARY Urinary Distress Inventory (UDI) Stress Subscale	-5.1; 4.2; -5.7; -0.5	—
SECONDARY Incontinence Severity Index	-0.9; 0.6; -0.9; 0.1	—

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.

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).

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Data sourced from ClinicalTrials.gov (NCT00460434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.