NCT00271037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2004

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 29, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

January 11, 2011

Status Verified

October 1, 2010

Enrollment Period

2.8 years

First QC Date

December 27, 2005

Last Update Submit

January 9, 2011

Conditions

Pelvic Organ ProlapseStress Urinary Incontinence

Keywords

Pelvic organ prolapseStress urinary incontinenceSurgeryColpocleisisUrinary retention

Interventions

Colpocleisis prolapse repair surgeryPROCEDURE
sling or other to treat or prevent stress incontinencePROCEDURE

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama

Birmingham, Alabama, 35249, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

  • 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.

    PMID: 15983731BACKGROUND

  • 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.

    PMID: 18690402RESULT

  • 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.

    PMID: 19960182RESULT

  • 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.

    PMID: 21344495DERIVED

Related Links

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary Incontinence, StressUrinary Retention

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and Symptoms

Study Officials

  • MaryPat FitzGerald, MD

    Loyola University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

December 27, 2005

First Posted

December 29, 2005

Study Start

July 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

January 11, 2011

Record last verified: 2010-10

Locations

US(6)