Colpocleisis for Advanced Pelvic Organ Prolapse

Completed

Conditions studied: Pelvic Organ Prolapse, Stress Urinary Incontinence

In brief

Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types of surgery try to restore the normal anatomy and function of the vagina (i.e., reconstructive surgery). Other surgery repairs the prolapse by essentially closing the vagina (e.g., colpocleisis or colpectomy), thereby leaving a woman unable to have vaginal intercourse in the future. The use of colpocleisis has not been well-studied. The current literature is lacking sufficient studies of colpocleisis to fully understand its risks and benefits for women considering surgery for prolapse. Traditionally, colpocleisis has been restricted to elderly women thought to be poor medical risks for prolonged reconstructive surgery. This study will describe the postoperative course of women who undergo colpocleisis, with particular attention to the persistence or recurrence of urinary incontinence and patient satisfaction after the colpocleisis prolapse surgery.

Key facts

Study ID

NCT00271037

Run by

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

People needed

152

Starts

2004-07-01

Expected to finish

2007-04-01

Last updated by the study team

2011-01-11

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult women
• Planned colpocleisis or colpectomy surgery for Stage III or Stage IV pelvic organ prolapse
• Able to provide informed consent and complete questionnaire data collection

You may not qualify if…

• Planned relocation to nursing home within 3 months of surgery
• Patient preference to maintain coital function after prolapse surgery

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Loyola University — Maywood, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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