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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
reconstruction of cystoceles using a subvesical prosthesis
Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route
CHU de clermont-Ferrand
Clermont-Ferrand, France
CHU de Lille
Lille, France
HFME - Hospices Civils de Lyon
Lyon, France
Clinique Beau-Soleil
Montpellier, France
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
≥ 2 to question 17 of PFDI-20 questionnaire
Time frame: 12 months after intervention
De novo dyspareunia rate the dyspareunia between groups
≥ 2 to question 11 of the PISQ-IR questionnaire.
Time frame: 12 months after the initial intervention
Quality of sexual life between groups
PISQ-IR questionnaire.
Time frame: 12 months after the initial intervention
Re-intervention for suburethral band (BSU) in de novo SUI between groups
binary: yes/no.
Time frame: up to 12 months after the initial intervention
Compare anatomical prolapse symptoms between groups
POP-Q questionnaire
Time frame: at 6 weeks and 12 months after intervention
Compare functional prolapse symptoms between groups
PFDI-20 questionnaire
Time frame: at 6 weeks and 12 months after intervention
Compare quality of life associated to pelvic floor issues between groups
PFIQ questionnaire
Time frame: at 6 weeks and 12 months after intervention
Compare general quality of life between groups
SF12 questionnaire
Time frame: at 6 weeks and 12 months after intervention
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CHU de Montpellier
Montpellier, France
CHU Nimes
Nîmes, France
Compare global satisfaction between groups
PGI-I questionnaire
Time frame: at 6 weeks and 12 months after intervention
Compare perioperational morbidity between groups
complication assessed as stage ≥2 on Clavien-Dindo classification, or according to the ICS/IUGA classification.
Time frame: at 6 weeks and 12 months after intervention
Compare direct and indirect costs of the 2 interventions
Time frame: 12 months after intervention