Pelvic Organ ProlapseNCT00714155
Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse
An observational study of Pelvic Organ Prolapse, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the long-term success rate of the colpocleisis procedure and its effect on quality of life in women who have this surgery. We want to see if women who have this surgery have problems with recurrent pelvic organ prolapse, urinary incontinence, or bowel problems after the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Questionnaires, Physical Examination
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jan 2009
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Urogynecology clinic
Who may be able to join
- women who underwent either total colpectomy with colpocleisis or partial colpectomy with LeFort-type colpocleisis performed by the Urogynecology service between 1/2000 and 12/2007 at Strong Memorial Hospital
Who cannot join
- women who are not undergone colpocleisis or colpectomy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the long-term success rate of the colpocleisis procedure and its effect on quality of life in women who have this surgery. We want to see if women who have this surgery have problems with recurrent pelvic organ prolapse, urinary incontinence, or bowel problems after the surgery. We also want to see how the surgery affects women's sexuality.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Questionnaires, Physical Examination
- Keywords
- Colpocleisis
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, Physical ExaminationOther
Questionnaires, Physical Examination
| Study group | Role | What they receive |
|---|---|---|
| 1 | Physical examination, questionnaires, retrospective chart review Receives: Other: Questionnaires, Physical Examination | |
| 2 | Questionnaires, retrospective chart review Receives: Other: Questionnaires, Physical Examination | |
| 3 | Retrospective chart review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires
Measured: Post-operative
Secondary outcomes (1)
Physical Examination
Measured: Post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Duecy, University of Rochester
- Investigators
- Erin E. Duecy, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714155
- Sponsor's protocol ID
- 15184
- Status last verified
- Nov 2011
- First submitted
- 8 Jul 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT00714155
- Acronym / sponsor ID
- 15184
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Colpocleisis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Jul 2008 (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.
The purpose of this study is to evaluate the long-term success rate of the colpocleisis procedure and its effect on quality of life in women who have this surgery. We want to see if women who have this surgery have problems with recurrent pelvic organ prolapse, urinary incontinence, or bowel problems after the surgery. We also want to see how the surgery affects women's sexuality.
Study design
- Observational model
- Cohort
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Questionnaires, Physical ExaminationPhysical examination, questionnaires, retrospective chart review |
| 2 | – | Other: Questionnaires, Physical ExaminationQuestionnaires, retrospective chart review |
| 3 | – | –Retrospective chart review |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Urogynecology clinic
Key inclusion criteria (1 listed)
- women who underwent either total colpectomy with colpocleisis or partial colpectomy with LeFort-type colpocleisis performed by the Urogynecology service between 1/2000 and 12/2007 at Strong Memorial Hospital
Key exclusion criteria (1 listed)
- women who are not undergone colpocleisis or colpectomy
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 |
|---|---|---|
| Questionnaires, Physical ExaminationQuestionnaires, Physical Examination | Other | 1, 2 |
Primary outcome
Questionnaires
Time frame: Post-operative
1 secondary outcome
Physical Examination
Time frame: Post-operative
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 14 Jun 2012.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Erin E. Duecy, MD principal investigator
University of Rochester
1 site 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, run by University of Rochester at 1 site 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 1 inclusion and 1 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Questionnaires (time frame: Post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2012.