NCT03919123

Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).

Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prolapse of the pelvic organs is a common pathology in women with a strong impact on the quality of life. Its prevalence tends to increase due to increased life expectancy and obesity. The main treatment is surgical and involves all organ specialists dealing with pelvic-perineal functional disorders: urologists, gynecologists, digestive surgeons. Our team wishes to evaluate, on a cohort of patients operated at the Caen University Hospital, the functional uro-gynecologic, digestive and sexual results of pelvic organ prolapse (POP) repair by Laparoscopic Promontofixation (PFL) through symptoms and quality of life validated questionnaires (QoL). The analysis of the responses to these questionnaires will allow us to evaluate the functional results in the short and medium term (from 6 months to 5 years)

Detailed description

This is a retrospective cohort study conducted at the Universitary hospital of Caen in three surgical departments (gynecology, urology and digestive surgery). Patients who had a laparoscopic promontofixation will be asked to respond to validated questionnaires of symptoms and quality of life after their surgery (PFDI-20, ICIQ-SF, PFIQ-7) and satisfaction (PGI-I)

Conditions

• Pelvic Organ Prolapse
• Symptoms
• Satisfaction
• Quality of Life

Interventions

Type	Name	Description
OTHER	Evaluation of laparoscopic promontofixation	Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-06-01
• Completion: 2022-10-01
• First posted: 2019-04-18
• Last updated: 2019-04-18

Locations

1 site across 1 country: France