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

Centre Hospitalier Universitaire de Nīmes

Status

Terminated

Conditions

Prolapse Genital

Treatments

Procedure: sacrospinofixation

Procedure: promontofixation

Study type

Interventional

Funder types

Other

Identifiers

NCT03200327

AOIGCSMERRI/2016/RdT01

Details and patient eligibility

About

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

Enrollment

55 patients

Sex

Female

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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