Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse

Not Applicable

Terminated

• Conditions: Prolapse Genital
• Interventions: Procedure: promontofixation; Procedure: sacrospinofixation

• Registration Number: NCT03200327
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Study Start: 2017-12-18
• Primary Completion: 2021-03-01
• Status Verified: 2022-01
• Study Completion: 2022-01-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• Patient must be available for 12 month follow-up
• Patient is ≥50 and <80 years old
• Patient has pelvic prolapse stage 2 or above according to international POP-Q score, concerning the anterior and apical compartments, justifying surgical treatment
• Patients not having preoperational stress urinary incontinence or having mild stress urinary incontinence not causing significant functional problems (response <2 to question 17 of PFDI-20 questionnaire). It is possible that patients with hidden stress urinary incontinence will be recruited

Exclusion Criteria

• The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
• The patient is under safeguard of justice or state guardianship
• The subject refuses to sign the consent
• Patient with communication issues preventing comprehension of information and administration of questionnaires
• Pelvic prolapse not affect anterior and apical compartments, regardless of stage
• Patient with preoperative dyspareunia (patients with mild sexual discomfort related to prolapse may be included
• Patient presents with preoperative stress urinary incontinence responsible of significant functional incapacity (response ≥2 to question 17 of PFDI-20 questionnaire).
• Indication for concomitant suburethral sling
• Patient with previous history of surgery for stress urinary incontinence
• Indication of concomitant perineorrhaphy surgery with or without myorrhaphy (in both groups).
• Contra-indication for general anesthetic
• Current urinary infection
• Current vaginal infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic promontofixation	promontofixation	-
Anterior vaginal sacrospinofixation	sacrospinofixation	-

Primary Outcome Measures

Name	Time	Method
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response	12 months after intervention	≥ 2 to question 17 of PFDI-20 questionnaire

Secondary Outcome Measures

Name	Time	Method
Compare quality of life associated to pelvic floor issues between groups	at 6 weeks and 12 months after intervention	PFIQ questionnaire
Re-intervention for suburethral band (BSU) in de novo SUI between groups	up to 12 months after the initial intervention	binary: yes/no.
Compare general quality of life between groups	at 6 weeks and 12 months after intervention	SF12 questionnaire
Compare global satisfaction between groups	at 6 weeks and 12 months after intervention	PGI-I questionnaire
De novo dyspareunia rate the dyspareunia between groups	12 months after the initial intervention	≥ 2 to question 11 of the PISQ-IR questionnaire.
Compare anatomical prolapse symptoms between groups	at 6 weeks and 12 months after intervention	POP-Q questionnaire
Compare functional prolapse symptoms between groups	at 6 weeks and 12 months after intervention	PFDI-20 questionnaire
Quality of sexual life between groups	12 months after the initial intervention	PISQ-IR questionnaire.
Compare perioperational morbidity between groups	at 6 weeks and 12 months after intervention	complication assessed as stage ≥2 on Clavien-Dindo classification, or according to the ICS/IUGA classification.
Compare direct and indirect costs of the 2 interventions	12 months after intervention

Trial Locations

Locations (6)

CHU de clermont-Ferrand; 🇫🇷 clermont-Ferrand, France

CHU de Lille; 🇫🇷 Lille, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Clinique Beau-Soleil; 🇫🇷 Montpellier, France

CHU Nimes; 🇫🇷 Nîmes, France

HFME - Hospices Civils de Lyon; 🇫🇷 Lyon, France