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

Prolapse Genital Clinical Trial

— SAPPRO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03200327
• Other study ID #: AOIGCSMERRI/2016/RdT01
• Status: Terminated
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: January 1, 2022
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Prolapse Genital

Intervention

Procedure:
• promontofixation
reconstruction of cystoceles using a subvesical prosthesis
• sacrospinofixation
Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route

Locations

Country	Name	City	State
France	CHU de clermont-Ferrand	clermont-Ferrand
France	CHU de Lille	Lille
France	HFME - Hospices Civils de Lyon	Lyon
France	CHU de Montpellier	Montpellier
France	Clinique Beau-Soleil	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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