Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL).

• Conditions: Satisfaction; Symptoms; Quality of Life; Pelvic Organ Prolapse

• Registration Number: NCT03919123
• Lead Sponsor: University Hospital, Caen

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)

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Study First Posted: 2019-04-18
• Last Update Posted: 2019-04-18
• Primary Completion: 2022-06
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms	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 Outcome Measures

Name	Time	Method
Sexual impact of laparoscopic promontofixation	3 years	Evaluation of the PISQ-12 score after laparoscopic promontofixation. This score was developped specifically to evaluate sexual troubles in case of genital prolapse
Evaluation of quality of life after prolapse surgery	3 years	Evaluation of the quality of life using a score specifically developped in case of genital prolapse : the PFIQ-7 score
Comparison of the different scores according to the operative indication (anterior promontofixation, double promontofixation, rectopexy alone)	3 years	Comparison of the PFDI-20 scores according to the operative indication
Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications	3 years	Evaluation of the PFDI-20 score in women undergoing laparoscopic rectopexy
Effect of laparoscopic promontofixation on urinary incontinence	3 years	Assessment of the ICIQ-SF score, a specific score developped to assess the impact urinary incontinence
Assessment of patient satisfaction after surgery	3 years	Evaluation of the quality of life using the PGI-I score, developped to quantify the effect of urinary or prolapse treatments

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Caen, Normandie, France