Clinical trial NCT03200327: Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
Official title: Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prolapse Genital
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 55
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
timeFrame: 12 months after intervention
Secondary outcomes:
measure: De novo dyspareunia rate the dyspareunia between groups
timeFrame: 12 months after the initial intervention
measure: Quality of sexual life between groups
timeFrame: 12 months after the initial intervention
measure: Re-intervention for suburethral band (BSU) in de novo SUI between groups
timeFrame: up to 12 months after the initial intervention
measure: Compare anatomical prolapse symptoms between groups
timeFrame: at 6 weeks and 12 months after intervention
measure: Compare functional prolapse symptoms between groups
timeFrame: at 6 weeks and 12 months after intervention
measure: Compare quality of life associated to pelvic floor issues between groups
timeFrame: at 6 weeks and 12 months after intervention
measure: Compare general quality of life between groups
timeFrame: at 6 weeks and 12 months after intervention
measure: Compare global satisfaction between groups
timeFrame: at 6 weeks and 12 months after intervention
measure: Compare perioperational morbidity between groups
timeFrame: at 6 weeks and 12 months after intervention
measure: Compare direct and indirect costs of the 2 interventions
timeFrame: 12 months after intervention
Other outcomes:
Locations:
city: clermont-Ferrand
country: France
facility: CHU de clermont-Ferrand
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: HFME - Hospices Civils de Lyon
city: Montpellier
country: France
facility: Clinique Beau-Soleil
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References: