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

NCT03200327 | Terminated

• 2 other identifiers: AOIGCSMERRI/2016/RdT012017-A01201-52
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 6

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

Conditions

Prolapse Genital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• De novo dyspareunia rate the dyspareunia between groups

  12 months after the initial intervention

• Quality of sexual life between groups

  12 months after the initial intervention

• Re-intervention for suburethral band (BSU) in de novo SUI between groups

  up to 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

Study Arms (2)

laparoscopic promontofixation

ACTIVE COMPARATOR

Procedure: promontofixation

Anterior vaginal sacrospinofixation

EXPERIMENTAL

Procedure: sacrospinofixation

Interventions

promontofixation PROCEDURE

reconstruction of cystoceles using a subvesical prosthesis

laparoscopic promontofixation

sacrospinofixation PROCEDURE

Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route

Anterior vaginal sacrospinofixation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

CHU de clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Lille

Lille, 59037, France

Location

HFME - Hospices Civils de Lyon

Lyon, 69677, France

Location

Clinique Beau-Soleil

Montpellier, 34070, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 35044477 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 27, 2017
• Study Start: December 18, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: December 4, 2025

Record last verified: 2022-01

Locations

FR (6)