Pelvic Organ ProlapseNCT00271037
Colpocleisis for Advanced Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Stress Urinary Incontinence
- What is being tested?
- Colpocleisis prolapse repair surgery and sling or other to treat or prevent stress incontinence
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2004to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult women undergoing colpocleisis for advanced pelvic organ prolapse (pelvic organ prolapse quantification (POP-Q) stage III-IV)
Who may be able to join
- 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
Who cannot join
- Planned relocation to nursing home within 3 months of surgery
- Patient preference to maintain coital function after prolapse surgery
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama
Birmingham, Alabama, 35249
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Iowa
Iowa City, Iowa, 52242
Loyola University
Maywood, Illinois, 60153
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse, Stress Urinary Incontinence
- Being tested
- Colpocleisis prolapse repair surgery, sling or other to treat or prevent stress incontinence
- Keywords
- Pelvic organ prolapse, Stress urinary incontinence, Surgery, Colpocleisis, Urinary retention
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colpocleisis prolapse repair surgeryProcedure or surgery
sling or other to treat or prevent stress incontinenceProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2005 (estimated)
- Study startJul 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- MaryPat FitzGerald, MD, Study chair, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271037
- Sponsor's protocol ID
- 7P01
- Other IDs
- U01HD041249, U10HD041268, U10HD041248, U10HD041250, U10HD041261, U10HD041263, U10HD041267
- Status last verified
- Oct 2010
- First submitted
- 27 Dec 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 15983731Fitzgerald 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.
PubMed 18690402Gutman 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.
PubMed 19960182Barber 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.
PubMed 21344495
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Symptoms and Patient Satisfaction After Colpocleisis for Advanced Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT00271037
- Acronym / sponsor ID
- 7P01
- Conditions
- Pelvic Organ Prolapse, Stress Urinary Incontinence
- Keywords
- Pelvic organ prolapse, Stress urinary incontinence, Surgery, Colpocleisis, Urinary retention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jul 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 29 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women undergoing colpocleisis for advanced pelvic organ prolapse (pelvic organ prolapse quantification (POP-Q) stage III-IV)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Planned relocation to nursing home within 3 months of surgery
- Patient preference to maintain coital function after prolapse surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colpocleisis prolapse repair surgery | Procedure or surgery | – |
| sling or other to treat or prevent stress incontinence | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
- Background: PubMed 15983731FitzGerald 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.
- Results publication: PubMed 18690402Fitzgerald 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.
- Results publication: PubMed 19960182Gutman 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.
- Derived from this study: PubMed 21344495Barber 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.
- Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MaryPat FitzGerald, MD study chair
Loyola University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Stress Urinary Incontinence, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00271037, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.