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

November 26, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand
      • Lille, France, 59037
        • CHU de LILLE
      • Lyon, France, 69677
        • HFME - Hospices Civils de Lyon
      • Montpellier, France, 34295
        • CHU de Montpellier
      • Montpellier, France, 34070
        • Clinique Beau-Soleil
      • Nîmes, France, 30029
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: laparoscopic promontofixation
Procedure: promontofixation
reconstruction of cystoceles using a subvesical prosthesis
Experimental: Anterior vaginal sacrospinofixation
Procedure: sacrospinofixation
Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
De novo dyspareunia rate the dyspareunia between groups
Time Frame: 12 months after the initial intervention
≥ 2 to question 11 of the PISQ-IR questionnaire.
12 months after the initial intervention
Quality of sexual life between groups
Time Frame: 12 months after the initial intervention
PISQ-IR questionnaire.
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
binary: yes/no.
up to 12 months after the initial intervention
Compare anatomical prolapse symptoms between groups
Time Frame: at 6 weeks and 12 months after intervention
POP-Q questionnaire
at 6 weeks and 12 months after intervention
Compare functional prolapse symptoms between groups
Time Frame: at 6 weeks and 12 months after intervention
PFDI-20 questionnaire
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
PFIQ questionnaire
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
SF12 questionnaire
at 6 weeks and 12 months after intervention
Compare global satisfaction between groups
Time Frame: at 6 weeks and 12 months after intervention
PGI-I questionnaire
at 6 weeks and 12 months after intervention
Compare perioperational morbidity between groups
Time Frame: at 6 weeks and 12 months after intervention
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
Time Frame: 12 months after intervention
12 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AOIGCSMERRI/2016/RdT01
  • 2017-A01201-52 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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