Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pelvic Organ Prolapse
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

To prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers. Primary outcome: anatomical cure rate (using simplified POP-Q staging system) Secondary outcomes: complication assessment (Clavien-Dindo), functional results, intraoper...

To prospectively assess the outcomes of robotic sacrocolpopexy for repair of pelvic organ prolapse in high volume european centers. Primary outcome: anatomical cure rate (using simplified POP-Q staging system) Secondary outcomes: complication assessment (Clavien-Dindo), functional results, intraoperative variables, impact of surgery on quality of life (PFIQ-7, PISQ-12)

Tracking Information

NCT #
NCT01598467
Collaborators
Not Provided
Investigators
Principal Investigator: Barry O'Reilly Cork University Hospital Study Chair: Steven E Schraffordt Koops Department of Gynecology and Obstetrics, Meander Medical Center, Amersfoort, The Netherlands Study Chair: Lorenzo Dutto Cork University Hospital