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Clinical Trials/NCT03919123
NCT03919123
Unknown
Not Applicable

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

University Hospital, Caen1 site in 1 country200 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
University Hospital, Caen
Enrollment
200
Locations
1
Primary Endpoint
Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms
Last Updated
7 years ago

Overview

Brief 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)

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
October 2022
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who have had a laparoscopic promotofixation for genital prolapse at the University Hospital of Caen between 2013 and 2018 in the departments of gynecology, urology and digestive surgery.
  • Patient who received written information and agreed to participate in the study

Exclusion Criteria

  • Minor patient, under guardianship, under trusteeship Patient not understanding French Refusal to participate in the study

Outcomes

Primary Outcomes

Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms

Time Frame: 3 years

The main objective is to collect the PFDI-20 score after the surgery. This score was developped to evaluate the genital, anorectal and digestive symptoms related to prolapse

Secondary Outcomes

  • Sexual impact of laparoscopic promontofixation(3 years)
  • Evaluation of quality of life after prolapse surgery(3 years)
  • Comparison of the different scores according to the operative indication (anterior promontofixation, double promontofixation, rectopexy alone)(3 years)
  • Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications(3 years)
  • Effect of laparoscopic promontofixation on urinary incontinence(3 years)
  • Assessment of patient satisfaction after surgery(3 years)

Study Sites (1)

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