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

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 Overview

• Status: Terminated
• Conditions: Prolapse Genital
• Intervention / Treatment: Procedure: promontofixation; Procedure: sacrospinofixation

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU de Clermont-Ferrand
  • Lille, France, 59037
    • CHU de LILLE
  • Lyon, France, 69677
    • HFME - Hospices Civils de Lyon
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Montpellier, France, 34070
    • Clinique Beau-Soleil
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laparoscopic promontofixation	Procedure: promontofixation; reconstruction of cystoceles using a subvesical prosthesis
Experimental: Anterior vaginal sacrospinofixation	Procedure: sacrospinofixation; Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
De novo dyspareunia rate the dyspareunia between groups	≥ 2 to question 11 of the PISQ-IR questionnaire.	12 months after the initial intervention
Quality of sexual life between groups	PISQ-IR questionnaire.	12 months after the initial intervention
Re-intervention for suburethral band (BSU) in de novo SUI between groups	binary: yes/no.	up to 12 months after the initial intervention
Compare anatomical prolapse symptoms between groups	POP-Q questionnaire	at 6 weeks and 12 months after intervention
Compare functional prolapse symptoms between groups	PFDI-20 questionnaire	at 6 weeks and 12 months after intervention
Compare quality of life associated to pelvic floor issues between groups	PFIQ questionnaire	at 6 weeks and 12 months after intervention
Compare general quality of life between groups	SF12 questionnaire	at 6 weeks and 12 months after intervention
Compare global satisfaction between groups	PGI-I questionnaire	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.	at 6 weeks and 12 months after intervention
Compare direct and indirect costs of the 2 interventions		12 months after intervention

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• de Tayrac R, Cosson M, Panel L, Compan C, Zemmache MZ, Bouvet S, Wagner L, Fatton B, Lamblin G. Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial. Int Urogynecol J. 2022 Jul;33(7):2021-2030. doi: 10.1007/s00192-021-05071-8. Epub 2022 Jan 19.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: AOIGCSMERRI/2016/RdT01; 2017-A01201-52 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No