Evaluation of Functional Outcomes After Laparoscopic Promontofixation (PFL). (PeSuLife)
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|ClinicalTrials.gov Identifier: NCT03919123|
Recruitment Status : Unknown
Verified April 2019 by University Hospital, Caen.
Recruitment status was: Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
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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)
|Condition or disease||Intervention/treatment|
|Pelvic Organ Prolapse Symptoms Satisfaction Quality of Life||Other: Evaluation of laparoscopic promontofixation|
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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||October 2022|
- Other: Evaluation of laparoscopic promontofixation
Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)
- 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
- Effect of laparoscopic promontofixation on urinary incontinence [ Time Frame: 3 years ]Assessment of the ICIQ-SF score, a specific score developped to assess the impact urinary incontinence
- Sexual impact of laparoscopic promontofixation [ Time Frame: 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 [ Time Frame: 3 years ]Evaluation of the quality of life using a score specifically developped in case of genital prolapse : the PFIQ-7 score
- Assessment of patient satisfaction after surgery [ Time Frame: 3 years ]Evaluation of the quality of life using the PGI-I score, developped to quantify the effect of urinary or prolapse treatments
- Specific evaluation of functional outcomes of laparoscopic rectopexy in rectocele or elytrocele indications [ Time Frame: 3 years ]Evaluation 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) [ Time Frame: 3 years ]Comparison of the PFDI-20 scores according to the operative indication
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
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
Minor patient, under guardianship, under trusteeship Patient not understanding French Refusal to participate in the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919123
|Contact: Estelle Jamard, Doctor||+33 6 88 32 32 firstname.lastname@example.org|
|Caen, Normandie, France, 14 000|
|Contact: Estelle Jamard, Doctor +33 6 88 32 32 11 email@example.com|
|Study Director:||Anne-Cécile Pizzoferrato, MD, PhD||Universitary hospital of Caen|
|Responsible Party:||University Hospital, Caen|
|Other Study ID Numbers:||
|First Posted:||April 18, 2019 Key Record Dates|
|Last Update Posted:||April 18, 2019|
|Last Verified:||April 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Pelvic Organ Prolapse
Quality of Life
Pelvic Organ Prolapse
Pathological Conditions, Anatomical