Status:
COMPLETED
Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy
Lead Sponsor:
University of Pittsburgh
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarge...
Eligibility Criteria
Inclusion
- Female subjects with pelvic organ prolapse (POP)
- Planning a surgical repair of POP with minimally invasive sacrocolpopexy
- Preoperative resting genital hiatus measure between 4.0 and 7.5cm
Exclusion
- subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above
- \*Note: we will NOT exclude patients based on prior surgical history (including prior posterior colporrhaphy)\*
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04480671
Start Date
August 26 2020
End Date
July 25 2024
Last Update
October 1 2024
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213