Colpocleisis for Advanced Pelvic Organ Prolapse
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse Stress Urinary Incontinence |
Procedure: Colpocleisis prolapse repair surgery Procedure: sling or other to treat or prevent stress incontinence |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pelvic Symptoms and Patient Satisfaction After Colpocleisis for Advanced Pelvic Organ Prolapse |
| Enrollment: | 152 |
| Study Start Date: | July 2004 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult women undergoing colpocleisis for advanced pelvic organ prolapse (pelvic organ prolapse quantification (POP-Q) stage III-IV)
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
Contacts and Locations| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35249 | |
| United States, Illinois | |
| Loyola University | |
| Maywood, Illinois, United States, 60153 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Study Chair: | MaryPat FitzGerald, MD | Loyola University |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Susan Meikle, MD, NICHD |
| ClinicalTrials.gov Identifier: | NCT00271037 History of Changes |
| Other Study ID Numbers: | 7P01, U01HD041249, U10HD041268, U10HD041248, U10HD041250, U10HD041261, U10HD041263, U10HD041267 |
| Study First Received: | December 27, 2005 |
| Last Updated: | January 9, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Pelvic organ prolapse Stress urinary incontinence Surgery Colpocleisis Urinary retention |
Additional relevant MeSH terms:
|
Prolapse Urinary Incontinence Urinary Incontinence, Stress Pelvic Organ Prolapse Pathological Conditions, Anatomical |
Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013