ProlapseNCT00271102
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
A study testing anterior vaginal repair (colporrhaphy) and abdominal paravaginal defect repair in people with Prolapse, run by Geisinger Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prolapse
- What is being tested?
- anterior vaginal repair (colporrhaphy) and abdominal paravaginal defect repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.
Who cannot join
- Patients with at least 2 previous prolapse surgeries
- Patients who are pregnant or planning to have a pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
Official title: Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.
Read the detailed description
It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.
- Conditions
- Prolapse
- Being tested
- anterior vaginal repair (colporrhaphy), abdominal paravaginal defect repair
- Keywords
- Cystocele, prolapse, anterior repair, colporrhaphy
- Medical subject headings
- Prolapse, Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior vaginal repair (colporrhaphy)Procedure or surgery
vaginal repair
abdominal paravaginal defect repairProcedure or surgery
abdominal repair
| Study group | Role | What they receive |
|---|---|---|
| Anterior colporrhaphy | Active comparator | Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) Receives: Procedure: anterior vaginal repair (colporrhaphy); Procedure: abdominal paravaginal defect repair |
| Paravaginal defect repair | Active comparator | Abdominal paravaginal defect repair cystocele (dropped bladder) Receives: Procedure: anterior vaginal repair (colporrhaphy); Procedure: abdominal paravaginal defect repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.
Measured: 4 years
Secondary outcomes (1)
The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionFeb 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vatche A Minassian, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271102
- Sponsor's protocol ID
- 2005-0193
- Status last verified
- Sep 2019
- First submitted
- 29 Dec 2005
- Last updated
- 27 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Christmann-Schmid C, Baessler K, Yeung E, Haya N, Mowat A, Chen Z, Wallace SA, Maher C. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2026 Apr 24;4(4):CD004014. doi: 10.1002/14651858.CD004014.pub7.
PubMed 42029168Minassian VA, Parekh M, Poplawsky D, Gorman J, Litzy L. Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Neurourol Urodyn. 2014 Jan;33(1):72-7. doi: 10.1002/nau.22396. Epub 2013 Mar 18.
PubMed 23508540
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
- ClinicalTrials.gov ID
- NCT00271102
- Acronym / sponsor ID
- 2005-0193
- Conditions
- Prolapse
- Keywords
- Cystocele, prolapse, anterior repair, colporrhaphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Dec 2005 (estimated)
- Results
- Posted 27 Sep 2019
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 determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.
Detailed description
It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior colporrhaphy | Active comparator | Procedure: anterior vaginal repair (colporrhaphy), Procedure: abdominal paravaginal defect repairAnterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) |
| Paravaginal defect repair | Active comparator | Procedure: anterior vaginal repair (colporrhaphy), Procedure: abdominal paravaginal defect repairAbdominal paravaginal defect repair cystocele (dropped bladder) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.
Key exclusion criteria (2 listed)
- Patients with at least 2 previous prolapse surgeries
- Patients who are pregnant or planning to have a pregnancy
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 |
|---|---|---|
| anterior vaginal repair (colporrhaphy)vaginal repair | Procedure or surgery | Anterior colporrhaphy, Paravaginal defect repair |
| abdominal paravaginal defect repairabdominal repair | Procedure or surgery | Anterior colporrhaphy, Paravaginal defect repair |
Primary outcome
Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
Time frame: 4 years
POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.
1 secondary outcome
The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42029168Christmann-Schmid C, Baessler K, Yeung E, Haya N, Mowat A, Chen Z, Wallace SA, Maher C. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2026 Apr 24;4(4):CD004014. doi: 10.1002/14651858.CD004014.pub7.
- Derived from this study: PubMed 23508540Minassian VA, Parekh M, Poplawsky D, Gorman J, Litzy L. Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Neurourol Urodyn. 2014 Jan;33(1):72-7. doi: 10.1002/nau.22396. Epub 2013 Mar 18.
- Click here for more information about Clinical Trials at Geisinger Medical CenterLink 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.
Vatche A Minassian, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anterior vaginal repair (colporrhaphy) and abdominal paravaginal defect repair in people with Prolapse, run by Geisinger Clinic 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 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 27 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00271102, which also lists 2 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 27 Sep 2019.