Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Anterior colporrhaphy Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) |
Procedure: anterior vaginal repair (colporrhaphy)
vaginal repair
Procedure: abdominal paravaginal defect repair
abdominal repair
|
Active Comparator: Paravaginal defect repair Abdominal paravaginal defect repair cystocele (dropped bladder) |
Procedure: anterior vaginal repair (colporrhaphy)
vaginal repair
Procedure: abdominal paravaginal defect repair
abdominal repair
|
Outcome Measures
Primary Outcome Measures
- Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery [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.
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
Patients with at least 2 previous prolapse surgeries
-
Patients who are pregnant or planning to have a pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Geisinger Health System | Danville | Pennsylvania | United States | 17822 |
Sponsors and Collaborators
- Geisinger Clinic
Investigators
- Principal Investigator: Vatche A Minassian, MD, Geisinger Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2005-0193
Study Results
Participant Flow
Recruitment Details | Dates of recruitment were between 2006 and 2010. Patients were recruited from the urogynecology outpatient clinic at Geisinger. |
---|---|
Pre-assignment Detail | 90 patients were screened for eligibility and 70 were recruited. The remaining 20 either declined participation or were not eligible. |
Arm/Group Title | Anterior Colporrhaphy | Paravaginal Defect Repair |
---|---|---|
Arm/Group Description | Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) | Abdominal paravaginal defect repair cystocele (dropped bladder) |
Period Title: Overall Study | ||
STARTED | 35 | 35 |
COMPLETED | 30 | 30 |
NOT COMPLETED | 5 | 5 |
Baseline Characteristics
Arm/Group Title | Anterior Colporrhaphy | Paravaginal Defect Repair | Total |
---|---|---|---|
Arm/Group Description | Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) | Abdominal paravaginal defect repair cystocele (dropped bladder) | Total of all reporting groups |
Overall Participants | 35 | 35 | 70 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
27
77.1%
|
26
74.3%
|
53
75.7%
|
>=65 years |
8
22.9%
|
9
25.7%
|
17
24.3%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
54
(11)
|
53
(13)
|
54
(12)
|
Sex: Female, Male (Count of Participants) | |||
Female |
35
100%
|
35
100%
|
70
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
United States |
35
100%
|
35
100%
|
70
100%
|
Outcome Measures
Title | Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery |
---|---|
Description | 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. |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
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). |
Arm/Group Title | POP Q Stage |
---|---|
Arm/Group Description | Prolapse stage at followed as measured by the POP-Q system |
Measure Participants | 0 |
Title | 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. |
---|---|
Description | |
Time Frame | 4 years |
Outcome Measure Data
Analysis Population Description |
---|
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). |
Arm/Group Title | Complications |
---|---|
Arm/Group Description | INtra-op and post-op complications |
Measure Participants | 0 |
Adverse Events
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 the time frame. | |||
---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||
Arm/Group Title | Anterior Colporrhaphy | Paravaginal Defect Repair | ||
Arm/Group Description | Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder) | Abdominal paravaginal defect repair cystocele (dropped bladder) | ||
All Cause Mortality |
||||
Anterior Colporrhaphy | Paravaginal Defect Repair | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | ||
Serious Adverse Events |
||||
Anterior Colporrhaphy | Paravaginal Defect Repair | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
Anterior Colporrhaphy | Paravaginal Defect Repair | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Office of Research Compliance |
---|---|
Organization | Geisinger |
Phone | 570-214-9628 |
orc@geisinger.edu |
- 2005-0193