Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder

Sponsor
Geisinger Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00271102
Collaborator
(none)
70
1
2
67
1

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
  • Procedure: anterior vaginal repair (colporrhaphy)
  • Procedure: abdominal paravaginal defect repair
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

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Aug 1, 2011

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

  1. 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

  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. [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT00271102
Other Study ID Numbers:
  • 2005-0193
First Posted:
Dec 30, 2005
Last Update Posted:
Sep 27, 2019
Last Verified:
Sep 1, 2019
Keywords provided by Geisinger Clinic
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Secondary Outcome
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

[Not Specified]

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
Email orc@geisinger.edu
Responsible Party:
Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT00271102
Other Study ID Numbers:
  • 2005-0193
First Posted:
Dec 30, 2005
Last Update Posted:
Sep 27, 2019
Last Verified:
Sep 1, 2019