Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

November 17, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial

The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.

Study Overview

Status

Status

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

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.

Detailed Description

Secondary objectives include the evaluation of the following:

  • Change from baseline of POP-Q scoring at 6 weeks, 6 months and 12 months post procedure, including evolution of treated or non-treated posterior compartments.
  • The proportion of patients with anatomical prolapse (C/D), but who are asymptomatic.
  • Change from baseline of mean quality-of-life scores.
  • Evaluation of mesh properties from procedure date through study period.
  • Peri-operative and post-treatment pain score assessment comparing the various anesthesia regimes used (Visual Analog Scale).
  • Assessment of patient subjective outcomes for overall treatment effects and satisfaction.
  • Objective evaluation of mesh shrinkage by standardized ultrasound measurements.

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.
121

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
      • Châtellerault, France, 86106
        • CH Camille Guérin
      • Clermont-Ferrand, France, 63003
        • CHU De Clermont Ferrand - Hopital Estaing
      • Dunkirk, France, 59385
        • CH de Dunkerque
      • Gonesse, France, 95500
        • CH de Gonesse
      • Lille, France, 59037
        • CHRU de Lille - Hôpital Jeanne de Flandre
      • Lyon, France, 69317
        • CHRU de Lyon - Hôpital de la Croix Rousse
      • Marseille, France, 13385
        • APHM - Hôpital de la Conception
      • Montpellier, France, 34070
        • Clinique Beau Soleil
      • Montpellier, France, 34295
        • CHU de Montpellier - Hôpital Lapeyronie
      • Nîmes, France, 30029
        • CHU de Nîmes - Hopital Universitaire Caremeau
      • Orange, France, 84106
        • CH Louis Giorgi
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Suresnes, France, 92150
        • Hopital Foch

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 12 months of follow-up
  • Patients with symptoms and altered quality of life in relation to uterine or post-hysterectomy vault prolapse
  • Patients who are receiving the UpholdTM LITE mesh Kit
  • Female patients >= years who have no desire of future pregnancy
  • Diagnosed with pelvic organ prolapse and >= ICS POP-Q Stage 2 Symptomatic Prolapse apical compartment (uterine or vault), associated with ICS POP-Q Stage 2 or 3 Symptomatic Prolapse anterior compartment (point Ba >= -1
  • Patients willing to complete quality of life questionnaire at baseline (pre-procedure) and at 6 weeks, 6 and 12 months post-procedure

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • Patients who are not receiving the UpHoldTM LITE mesh Kit
  • Patients < 50 years
  • Patients qho, according to the clinical judgment of the investigator, are not suitable for this study
  • Patients who are considering future pregnancies
  • Patients whose pelvic organ prolapse is a <= 1 ICS Stage
  • Patients requiring Posterior Graft procedure
  • Patients with known or suspected hypersensitivity to polypropylene
  • Patients with any pathology which ould compromise implant placement
  • Patients with any pathology which ould compromise implant placement as mentioned in the device instruction manual
  • Patients with any pathology that would limit blood supply and compromise healing
  • Patients with blood coagulation disorder (associated current level coagulation)
  • Patients with autoimmune connective tissue disease
  • Patients with upper urinary tract obstruction and renal insufficiency
  • Patients with local or systemic 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: N/A
  • Interventional Model: Single Group 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.
Experimental: Prolapse patients recieving UpHold LITE
Non-pregnant female patients >= 50 years who are not considering future pregnancies, who are diagnosed with uterine or vault prolapse with ICS POP-Q score of stage 2 or greater, who are receiving the UpholdTM LITE mesh kit and who agree to be in the study.
Device: UpholdTM LITE placement
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.

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
Apical anatomical success
Time Frame: 12 months
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
12 months
Anterior vaginal wall anatomical success
Time Frame: 12 months
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
12 months
Change from baseline in PFDI-20 scores
Time Frame: baseline to 12 lines
baseline to 12 lines

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
Anterior vaginal wall anatomical success
Time Frame: 6 months
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
6 months
Apical anatomical success
Time Frame: 6 weeks
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
6 weeks
Apical anatomical success
Time Frame: 6 months
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
6 months
Anterior vaginal wall anatomical success
Time Frame: 6 weeks
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)
6 weeks
Change from baseline in PFDI-20 scores
Time Frame: baseline to 6 weeks
baseline to 6 weeks
Change from baseline in PFDI-20 scores
Time Frame: baseline to 6 months
baseline to 6 months
Change from baseline in PFIQ-7 scores
Time Frame: baseline to 6 weeks
baseline to 6 weeks
Change from baseline in PFIQ-7 scores
Time Frame: baseline to 6 months
baseline to 6 months
Change from baseline in PFIQ-7 scores
Time Frame: baseline to 12 months
baseline to 12 months
Change from baseline in PISQ-12 scores
Time Frame: baseline to 6 months
baseline to 6 months
Change from baseline in PISQ-12 scores
Time Frame: baseline to 12 months
baseline to 12 months
length of hospital stay (days)
Time Frame: 6 weeks
6 weeks
Number of days necessary for return to normal activities
Time Frame: 6 weeks
6 weeks
Visual analog scale for post-operative pain
Time Frame: Day 1
score ranging from 0.0 to 10.0
Day 1
Visual analog scale for post-operative pain
Time Frame: 6 weeks
score ranging from 0.0 to 10.0
6 weeks
Visual analog scale for post-operative pain
Time Frame: 6 months
score ranging from 0.0 to 10.0
6 months
Visual analog scale for post-operative pain
Time Frame: 12 months
score ranging from 0.0 to 10.0
12 months
Mesh related morbidity
Time Frame: Day 1
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Day 1
Mesh related morbidity
Time Frame: 6 weeks
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
6 weeks
Mesh related morbidity
Time Frame: 6 months
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
6 months
Mesh related morbidity
Time Frame: 12 months
Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
12 months
Mesh contraction (cm)
Time Frame: 6 weeks
Mesh contraction as determined by ultrasound measurement (cm)
6 weeks
Mesh contraction (cm)
Time Frame: 6 months
Mesh contraction as determined by ultrasound measurement (cm)
6 months
Mesh contraction (cm)
Time Frame: 12 months
Mesh contraction as determined by ultrasound measurement (cm)
12 months
Patient satisfaction (PGI index) score
Time Frame: 6 weeks
6 weeks
Patient satisfaction (PGI index) score
Time Frame: 6 months
6 months
Patient satisfaction (PGI index) score
Time Frame: 12 months
12 months

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nîmes

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

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.
October 1, 2012

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.
October 12, 2016

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.
October 12, 2016

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).
March 19, 2012

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.
March 20, 2012

First Posted (Estimated)

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.
March 21, 2012

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.
November 19, 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 17, 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, 2017

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.
  • LOCAL/2011/RdeT-04
  • 2011-A01705-36 (Other Identifier: ANSM)

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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