Colpocleisis for Advanced Pelvic Organ Prolapse

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Stress Urinary Incontinence; Pelvic Organ Prolapse

Treatments: Procedure: Colpocleisis prolapse repair surgery; Procedure: sling or other to treat or prevent stress incontinence

Study type: Observational

Funder types: NIH

Identifiers

NCT00271037

U10HD041261 (U.S. NIH Grant/Contract)

U10HD041268 (U.S. NIH Grant/Contract)

U10HD041248 (U.S. NIH Grant/Contract)

7P01

U10HD041263 (U.S. NIH Grant/Contract)

U10HD041267 (U.S. NIH Grant/Contract)

U01HD041249

U10HD041250 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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 prolapse surgery 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.

Women who agree to participate in the study will complete questionnaires before surgery, and at 3 months and 1 year after surgery. Questionnaires include the Pelvic Floor Distress Inventory (PFDI), which includes questions about pelvic symptoms and the level of bother the symptoms cause; the Pelvic Floor Impact Questionnaire (PFIQ), which includes questions about the impact on life activities; and the SF-36, which measures health-related quality of life.

Comparisons: Symptoms that may be related to prolapse, such as urinary incontinence, will be compared in women before and after surgery to see if the surgery provides improvement in those symptoms. In addition, patient satisfaction and health-related quality of life will be studied by making comparisons before and after prolapse surgery repair.

Enrollment: 152 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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