Prolapse GenitalSAPPRONCT03200327
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
A study testing promontofixation and sacrospinofixation in people with Prolapse Genital, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
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 Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Prolapse Genital
- What is being tested?
- promontofixation and sacrospinofixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 6 sitesFrance
- Study dates
- 18 Dec 2017to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de clermont-Ferrand
Clermont-Ferrand, 63003
CHU de Lille
Lille, 59037
HFME - Hospices Civils de Lyon
Lyon, 69677
Clinique Beau-Soleil
Montpellier, 34070
CHU de Montpellier
Montpellier, 34295
CHU Nimes
Nîmes, 30029
About this study
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
- Being tested
- promontofixation, sacrospinofixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
promontofixationProcedure or surgery
reconstruction of cystoceles using a subvesical prosthesis
sacrospinofixationProcedure or surgery
Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic promontofixation | Active comparator | Not described Receives: Procedure: promontofixation |
| Anterior vaginal sacrospinofixation | Experimental | Not described Receives: Procedure: sacrospinofixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
≥ 2 to question 17 of PFDI-20 questionnaire
Measured: 12 months after intervention
Secondary outcomes (10)
De novo dyspareunia rate the dyspareunia between groups
≥ 2 to question 11 of the PISQ-IR questionnaire.
Measured: 12 months after the initial intervention
Quality of sexual life between groups
PISQ-IR questionnaire.
Measured: 12 months after the initial intervention
Re-intervention for suburethral band (BSU) in de novo SUI between groups
binary: yes/no.
Measured: up to 12 months after the initial intervention
Compare anatomical prolapse symptoms between groups
POP-Q questionnaire
Measured: at 6 weeks and 12 months after intervention
Compare functional prolapse symptoms between groups
PFDI-20 questionnaire
Measured: at 6 weeks and 12 months after intervention
Compare quality of life associated to pelvic floor issues between groups
PFIQ questionnaire
Measured: at 6 weeks and 12 months after intervention
Compare general quality of life between groups
SF12 questionnaire
Measured: at 6 weeks and 12 months after intervention
Compare global satisfaction between groups
PGI-I questionnaire
Measured: 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.
Measured: at 6 weeks and 12 months after intervention
Compare direct and indirect costs of the 2 interventions
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start18 Dec 2017
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Why it stopped: withdrawal of vaginal prosthesis from the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolapse GenitalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200327
- Sponsor's protocol ID
- AOIGCSMERRI/2016/RdT01
- Other IDs
- 2017-A01201-52
- Acronym
- SAPPRO
- Status last verified
- Jan 2022
- First submitted
- 23 Jun 2017
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35044477
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse
- ClinicalTrials.gov ID
- NCT03200327
- Acronym / sponsor ID
- SAPPRO / AOIGCSMERRI/2016/RdT01
- Conditions
- Prolapse Genital
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: withdrawal of vaginal prosthesis from the market
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic promontofixation | Active comparator | Procedure: promontofixation |
| Anterior vaginal sacrospinofixation | Experimental | Procedure: sacrospinofixation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| promontofixationreconstruction of cystoceles using a subvesical prosthesis | Procedure or surgery | laparoscopic promontofixation |
| sacrospinofixationUtero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route | Procedure or surgery | Anterior vaginal sacrospinofixation |
Primary outcome
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response
Time frame: 12 months after intervention
≥ 2 to question 17 of PFDI-20 questionnaire
10 secondary outcomes
De novo dyspareunia rate the dyspareunia between groups
Time frame: 12 months after the initial intervention
Quality of sexual life between groups
Time frame: 12 months after the initial intervention
Re-intervention for suburethral band (BSU) in de novo SUI between groups
Time frame: up to 12 months after the initial intervention
Compare anatomical prolapse symptoms between groups
Time frame: at 6 weeks and 12 months after intervention
Compare functional prolapse symptoms between groups
Time frame: at 6 weeks and 12 months after intervention
Compare quality of life associated to pelvic floor issues between groups
Time frame: at 6 weeks and 12 months after intervention
Compare general quality of life between groups
Time frame: at 6 weeks and 12 months after intervention
Compare global satisfaction between groups
Time frame: at 6 weeks and 12 months after intervention
Compare perioperational morbidity between groups
Time frame: at 6 weeks and 12 months after intervention
Compare direct and indirect costs of the 2 interventions
Time frame: 12 months after intervention
Results and safety
The study was stopped early (reason given: withdrawal of vaginal prosthesis from the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 35044477de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing promontofixation and sacrospinofixation in people with Prolapse Genital, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: withdrawal of vaginal prosthesis from the market). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the rate of de novo problematic stress urinary incontinence, operable or not, between groups response (time frame: 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.