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Colpocleisis for Advanced Pelvic Organ Prolapse

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Completed
CT.gov ID
NCT00271037
Collaborator
(none)
152
Enrollment
6
Locations
33
Duration (Months)
25.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Colpocleisis prolapse repair surgery
  • Procedure: sling or other to treat or prevent stress incontinence

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
152 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pelvic Symptoms and Patient Satisfaction After Colpocleisis for Advanced Pelvic Organ Prolapse
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Alabama United States 35249
    2 Loyola University Maywood Illinois United States 60153
    3 University of Iowa Iowa City Iowa United States 52242
    4 Johns Hopkins University Baltimore Maryland United States 21224
    5 University of North Carolina Chapel Hill North Carolina United States 27599
    6 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: MaryPat FitzGerald, MD, Loyola University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00271037
    Other Study ID Numbers:
    • 7P01
    • U01HD041249
    • U10HD041268
    • U10HD041248
    • U10HD041250
    • U10HD041261
    • U10HD041263
    • U10HD041267
    First Posted:
    Dec 29, 2005
    Last Update Posted:
    Jan 11, 2011
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    Pelvic organ prolapse
    Stress urinary incontinence
    Surgery
    Colpocleisis
    Urinary retention
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Jan 11, 2011