Trial Outcomes & Findings for Apical Support During Hysterectomy for Pelvic Organ Prolapse (NCT NCT03379246)
NCT ID: NCT03379246
Last Updated: 2023-09-01
Results Overview
proportion of patients who had concurrent apical support procedures performed
Recruitment status
COMPLETED
Target enrollment
236 participants
Primary outcome timeframe
at time of hysterectomy for pelvic organ prolapse
Results posted on
2023-09-01
Participant Flow
Participant milestones
| Measure |
Pelvic Organ Prolapse
patients who underwent hysterectomy for pelvic organ prolapse at any of the affiliated TriHealth hospitals between October 2012 and October of 2017
|
|---|---|
|
Overall Study
STARTED
|
236
|
|
Overall Study
COMPLETED
|
236
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Apical Support During Hysterectomy for Pelvic Organ Prolapse
Baseline characteristics by cohort
| Measure |
Pelvic Organ Prolapse
n=236 Participants
patients who underwent hysterectomy for pelvic organ prolapse at any of the affiliated TriHealth hospitals between October 2012 and October of 2017
|
|---|---|
|
Age, Continuous
|
52.86 years
STANDARD_DEVIATION 12.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
236 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
225 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unavailable
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
236 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at time of hysterectomy for pelvic organ prolapseproportion of patients who had concurrent apical support procedures performed
Outcome measures
| Measure |
Pelvic Organ Prolapse
n=236 Participants
patients who underwent hysterectomy for pelvic organ prolapse at any of the affiliated TriHealth hospitals between October 2012 and October of 2017
|
|---|---|
|
Proportion of Patients Having Concurrent Apical Suspension Performed
|
66 Participants
|
Adverse Events
Pelvic Organ Prolapse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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