Colpocleisis for Advanced Pelvic Organ Prolapse

Pelvic Symptoms and Patient Satisfaction After Colpocleisis for Advanced Pelvic Organ Prolapse

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Stress Urinary Incontinence
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult women undergoing colpocleisis for advanced pelvic organ prolapse (pelvic organ prolapse quantification (POP-Q) stage III-IV)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Chair: MaryPat FitzGerald, MD, Loyola University

Publications and helpful links

General Publications

• FitzGerald MP, Richter HE, Siddique S, Thompson P, Zyczynski H; Ann Weber for the Pelvic Floor Disorders Network. Colpocleisis: a review. Int Urogynecol J Pelvic Floor Dysfunct. 2006 May;17(3):261-71. doi: 10.1007/s00192-005-1339-9. Epub 2005 Jun 28.
• Fitzgerald MP, Richter HE, Bradley CS, Ye W, Visco AC, Cundiff GW, Zyczynski HM, Fine P, Weber AM; Pelvic Floor Disorders Network. Pelvic support, pelvic symptoms, and patient satisfaction after colpocleisis. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1603-9. doi: 10.1007/s00192-008-0696-6. Epub 2008 Aug 9.
• Gutman RE, Bradley CS, Ye W, Markland AD, Whitehead WE, Fitzgerald MP; Pelvic Floor Disorders Network. Effects of colpocleisis on bowel symptoms among women with severe pelvic organ prolapse. Int Urogynecol J. 2010 Apr;21(4):461-6. doi: 10.1007/s00192-009-1062-z. Epub 2009 Dec 4.
• Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourol Urodyn. 2011 Apr;30(4):541-6. doi: 10.1002/nau.20934. Epub 2011 Feb 22.

Helpful Links

• Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders Network

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: December 27, 2005
• First Submitted That Met QC Criteria: December 27, 2005
• First Posted (Estimate): December 29, 2005

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 9, 2011
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Surgery; Stress urinary incontinence; Urinary retention; Pelvic organ prolapse; Colpocleisis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 7P01; U01HD041249 (U.S. NIH Grant/Contract); U10HD041268 (U.S. NIH Grant/Contract); U10HD041248 (U.S. NIH Grant/Contract); U10HD041250 (U.S. NIH Grant/Contract); U10HD041261 (U.S. NIH Grant/Contract); U10HD041263 (U.S. NIH Grant/Contract); U10HD041267 (U.S. NIH Grant/Contract)