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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03919123
Acronym
PeSuLife
Enrollment
200
Registered
2019-04-18
Start date
2019-01-01
Completion date
2022-10-31
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, Quality of Life, Satisfaction, Symptoms

Keywords

Pelvic Organ Prolapse, laparoscopic promontofixation, symptoms, Satisfaction, Quality of Life

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)

Interventions

OTHEREvaluation of laparoscopic promontofixation

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

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of laparoscopic promontofixation on urogynecologic and digestive symptoms3 yearsThe 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

MeasureTime frameDescription
Effect of laparoscopic promontofixation on urinary incontinence3 yearsAssessment of the ICIQ-SF score, a specific score developped to assess the impact urinary incontinence
Sexual impact of laparoscopic promontofixation3 yearsEvaluation 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 surgery3 yearsEvaluation of the quality of life using a score specifically developped in case of genital prolapse : the PFIQ-7 score
Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications3 yearsEvaluation of the PFDI-20 score in women undergoing laparoscopic rectopexy
Comparison of the different scores according to the operative indication (anterior promontofixation, double promontofixation, rectopexy alone)3 yearsComparison of the PFDI-20 scores according to the operative indication
Assessment of patient satisfaction after surgery3 yearsEvaluation of the quality of life using the PGI-I score, developped to quantify the effect of urinary or prolapse treatments

Countries

France

Contacts

Primary ContactEstelle Jamard, Doctor
estelle.jamard@hotmail.fr+33 6 88 32 32 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026