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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior colporrhaphy | Active Comparator | Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) |
|
| Paravaginal defect repair | Active Comparator | Abdominal paravaginal defect repair cystocele (dropped bladder) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anterior vaginal repair (colporrhaphy) | Procedure | vaginal repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vatche A Minassian, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Health System | Danville | Pennsylvania | 17822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42029168 | Derived | 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. | |
| 23508540 | Derived | Minassian 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. |
| Label | URL |
|---|---|
| Click here for more information about Clinical Trials at Geisinger Medical Center | View source |
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90 patients were screened for eligibility and 70 were recruited. The remaining 20 either declined participation or were not eligible.
Dates of recruitment were between 2006 and 2010. Patients were recruited from the urogynecology outpatient clinic at Geisinger.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anterior Colporrhaphy | Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) |
| FG001 | Paravaginal Defect Repair | Abdominal paravaginal defect repair cystocele (dropped bladder) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anterior Colporrhaphy | Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) |
| BG001 | Paravaginal Defect Repair | Abdominal paravaginal defect repair cystocele (dropped bladder) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s). | Posted | 4 years |
|
Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for the time frame.
Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anterior Colporrhaphy | Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Office of Research Compliance | Geisinger | 570-214-9628 | orc@geisinger.edu |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| D052858 | Cystocele |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
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| abdominal paravaginal defect repair | Procedure | abdominal repair |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | 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. | Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table(s). | Posted | 4 years |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Paravaginal Defect Repair | Abdominal paravaginal defect repair cystocele (dropped bladder) | 0 | 0 | 0 | 0 | 0 | 0 |
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |