Trial Outcomes & Findings for Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder (NCT NCT00271102)
NCT ID: NCT00271102
Last Updated: 2019-09-27
Results Overview
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.
COMPLETED
NA
70 participants
4 years
2019-09-27
Participant Flow
Dates of recruitment were between 2006 and 2010. Patients were recruited from the urogynecology outpatient clinic at Geisinger.
90 patients were screened for eligibility and 70 were recruited. The remaining 20 either declined participation or were not eligible.
Participant milestones
| Measure |
Anterior Colporrhaphy
Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
|
Paravaginal Defect Repair
Abdominal paravaginal defect repair cystocele (dropped bladder)
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
Baseline characteristics by cohort
| Measure |
Anterior Colporrhaphy
n=35 Participants
Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
|
Paravaginal Defect Repair
n=35 Participants
Abdominal paravaginal defect repair cystocele (dropped bladder)
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 11 • n=99 Participants
|
53 years
STANDARD_DEVIATION 13 • n=107 Participants
|
54 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
35 participants
n=107 Participants
|
70 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: 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).
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: 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).
Outcome measures
Outcome data not reported
Adverse Events
Anterior Colporrhaphy
Paravaginal Defect Repair
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place