Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).

Last updated: April 17, 2019
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Prolapse

Treatment

N/A

Clinical Study ID

NCT03919123
2018-A02927-48
  • Ages > 18
  • Female

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients who have had a laparoscopic promotofixation for genital prolapse at the UniversityHospital of Caen between 2013 and 2018 in the departments of gynecology, urology anddigestive surgery. Patient who received written information and agreed to participate in the study

Exclusion

Exclusion Criteria: Minor patient, under guardianship, under trusteeship Patient not understanding FrenchRefusal to participate in the study

Study Design

Total Participants: 200
Study Start date:
January 01, 2019
Estimated Completion Date:
October 31, 2022

Study 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)

Connect with a study center

  • University Hospital

    Caen, Normandie 14 000
    France

    Active - Recruiting

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