Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse (SAPPRO)
Primary Purpose
Prolapse Genital
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
promontofixation
sacrospinofixation
Sponsored by
About this trial
This is an interventional treatment trial for Prolapse Genital
Eligibility Criteria
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
Sites / Locations
- CHU de clermont-Ferrand
- CHU de Lille
- HFME - Hospices Civils de Lyon
- Clinique Beau-Soleil
- CHU de Montpellier
- CHU Nimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
laparoscopic promontofixation
Anterior vaginal sacrospinofixation
Arm Description
Outcomes
Primary Outcome Measures
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
≥ 2 to question 17 of PFDI-20 questionnaire
Secondary Outcome Measures
De novo dyspareunia rate the dyspareunia between groups
≥ 2 to question 11 of the PISQ-IR questionnaire.
Quality of sexual life between groups
PISQ-IR questionnaire.
Re-intervention for suburethral band (BSU) in de novo SUI between groups
binary: yes/no.
Compare anatomical prolapse symptoms between groups
POP-Q questionnaire
Compare functional prolapse symptoms between groups
PFDI-20 questionnaire
Compare quality of life associated to pelvic floor issues between groups
PFIQ questionnaire
Compare general quality of life between groups
SF12 questionnaire
Compare global satisfaction between groups
PGI-I questionnaire
Compare perioperational morbidity between groups
complication assessed as stage ≥2 on Clavien-Dindo classification, or according to the ICS/IUGA classification.
Compare direct and indirect costs of the 2 interventions
Full Information
NCT ID
NCT03200327
First Posted
June 23, 2017
Last Updated
January 24, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03200327
Brief Title
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
Acronym
SAPPRO
Official Title
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
withdrawal of vaginal prosthesis from the market
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse Genital
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic promontofixation
Arm Type
Active Comparator
Arm Title
Anterior vaginal sacrospinofixation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
promontofixation
Intervention Description
reconstruction of cystoceles using a subvesical prosthesis
Intervention Type
Procedure
Intervention Name(s)
sacrospinofixation
Intervention Description
Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route
Primary Outcome Measure Information:
Title
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
Description
≥ 2 to question 17 of PFDI-20 questionnaire
Time Frame
12 months after intervention
Secondary Outcome Measure Information:
Title
De novo dyspareunia rate the dyspareunia between groups
Description
≥ 2 to question 11 of the PISQ-IR questionnaire.
Time Frame
12 months after the initial intervention
Title
Quality of sexual life between groups
Description
PISQ-IR questionnaire.
Time Frame
12 months after the initial intervention
Title
Re-intervention for suburethral band (BSU) in de novo SUI between groups
Description
binary: yes/no.
Time Frame
up to 12 months after the initial intervention
Title
Compare anatomical prolapse symptoms between groups
Description
POP-Q questionnaire
Time Frame
at 6 weeks and 12 months after intervention
Title
Compare functional prolapse symptoms between groups
Description
PFDI-20 questionnaire
Time Frame
at 6 weeks and 12 months after intervention
Title
Compare quality of life associated to pelvic floor issues between groups
Description
PFIQ questionnaire
Time Frame
at 6 weeks and 12 months after intervention
Title
Compare general quality of life between groups
Description
SF12 questionnaire
Time Frame
at 6 weeks and 12 months after intervention
Title
Compare global satisfaction between groups
Description
PGI-I questionnaire
Time Frame
at 6 weeks and 12 months after intervention
Title
Compare perioperational morbidity between groups
Description
complication assessed as stage ≥2 on Clavien-Dindo classification, or according to the ICS/IUGA classification.
Time Frame
at 6 weeks and 12 months after intervention
Title
Compare direct and indirect costs of the 2 interventions
Time Frame
12 months after intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de clermont-Ferrand
City
clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HFME - Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69677
Country
France
Facility Name
Clinique Beau-Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
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