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

Study Overview
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Brief Summary
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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

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

Conditions
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Prolapse Genital

Intervention / Treatment
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* Procedure: promontofixation
* Procedure: sacrospinofixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |