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

Centre Hospitalier Universitaire de Nīmes6 sites in 1 country55 target enrollmentDecember 18, 2017

ConditionsProlapse Genital

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prolapse Genital
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 55
Locations: 6
Primary Endpoint: Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
Status: Terminated
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 18, 2017

End Date

March 1, 2021

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response

Time Frame: 12 months after intervention

≥ 2 to question 17 of PFDI-20 questionnaire

Secondary Outcomes

Compare quality of life associated to pelvic floor issues between groups(at 6 weeks and 12 months after intervention)
Re-intervention for suburethral band (BSU) in de novo SUI between groups(up to 12 months after the initial intervention)
Compare general quality of life between groups(at 6 weeks and 12 months after intervention)
Compare global satisfaction between groups(at 6 weeks and 12 months after intervention)
De novo dyspareunia rate the dyspareunia between groups(12 months after the initial intervention)
Compare anatomical prolapse symptoms between groups(at 6 weeks and 12 months after intervention)
Compare functional prolapse symptoms between groups(at 6 weeks and 12 months after intervention)
Quality of sexual life between groups(12 months after the initial intervention)
Compare perioperational morbidity between groups(at 6 weeks and 12 months after intervention)
Compare direct and indirect costs of the 2 interventions(12 months after intervention)