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Pelvic Organ ProlapseNCT01559168

Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

A study testing UpholdTM LITE placement in people with Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 13 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Pelvic Organ Prolapse
What is being tested?
UpholdTM LITE placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
13 sitesFrance
Study dates
Oct 2012to 12 Oct 2016
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • CH Camille Guérin

    Châtellerault, 86106

  • CHU de Clermont Ferrand - Hôpital Estaing

    Clermont-Ferrand, 63003

  • CH de Dunkerque

    Dunkirk, 59385

  • CH de Gonesse

    Gonesse, 95500

  • CHRU de Lille - Hôpital Jeanne de Flandre

    Lille, 59037

  • CHRU de Lyon - Hôpital de la Croix Rousse

    Lyon, 69317

  • APHM - Hôpital de la Conception

    Marseille, 13385

  • Clinique Beau Soleil

    Montpellier, 34070

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

  • CH Louis Giorgi

    Orange, 84106

  • CHU de Poitiers

    Poitiers, 86021

  • Hôpital Foch

    Suresnes, 92150

Other trials in France

About this study

Official title: 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.

Read the 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.
Being tested
UpholdTM LITE placement
Medical subject headings
Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpholdTM LITE placementDevice

    Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.

Study groups in NCT01559168
Study groupRoleWhat they receive
Prolapse patients recieving UpHold LITEExperimentalNon-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.
Receives: Device: UpholdTM LITE placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apical anatomical success

    Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)

    Measured: 12 months

  2. Anterior vaginal wall anatomical success

    Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)

    Measured: 12 months

  3. Change from baseline in PFDI-20 scores

    Measured: baseline to 12 lines

Secondary outcomes (27)

  1. Anterior vaginal wall anatomical success

    Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)

    Measured: 6 months

  2. Apical anatomical success

    Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)

    Measured: 6 weeks

  3. Apical anatomical success

    Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)

    Measured: 6 months

  4. Anterior vaginal wall anatomical success

    Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS)

    Measured: 6 weeks

  5. Change from baseline in PFDI-20 scores

    Measured: baseline to 6 weeks

  6. Change from baseline in PFDI-20 scores

    Measured: baseline to 6 months

  7. Change from baseline in PFIQ-7 scores

    Measured: baseline to 6 weeks

  8. Change from baseline in PFIQ-7 scores

    Measured: baseline to 6 months

  9. Change from baseline in PFIQ-7 scores

    Measured: baseline to 12 months

  10. Change from baseline in PISQ-12 scores

    Measured: baseline to 6 months

  11. Change from baseline in PISQ-12 scores

    Measured: baseline to 12 months

  12. length of hospital stay (days)

    Measured: 6 weeks

  13. Number of days necessary for return to normal activities

    Measured: 6 weeks

  14. Visual analog scale for post-operative pain

    score ranging from 0.0 to 10.0

    Measured: Day 1

  15. Visual analog scale for post-operative pain

    score ranging from 0.0 to 10.0

    Measured: 6 weeks

  16. Visual analog scale for post-operative pain

    score ranging from 0.0 to 10.0

    Measured: 6 months

  17. Visual analog scale for post-operative pain

    score ranging from 0.0 to 10.0

    Measured: 12 months

  18. Mesh related morbidity

    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

    Measured: Day 1

  19. Mesh related morbidity

    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

    Measured: 6 weeks

  20. Mesh related morbidity

    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

    Measured: 6 months

  21. Mesh related morbidity

    Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)

    Measured: 12 months

  22. Mesh contraction (cm)

    Mesh contraction as determined by ultrasound measurement (cm)

    Measured: 6 weeks

  23. Mesh contraction (cm)

    Mesh contraction as determined by ultrasound measurement (cm)

    Measured: 6 months

  24. Mesh contraction (cm)

    Mesh contraction as determined by ultrasound measurement (cm)

    Measured: 12 months

  25. Patient satisfaction (PGI index) score

    Measured: 6 weeks

  26. Patient satisfaction (PGI index) score

    Measured: 6 months

  27. Patient satisfaction (PGI index) score

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2012 (estimated)
  2. Study startOct 2012
  3. Primary completion12 Oct 2016
  4. Study completion12 Oct 2016

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01559168
Sponsor's protocol ID
LOCAL/2011/RdeT-04
Other IDs
2011-A01705-36
Status last verified
Jan 2017
First submitted
19 Mar 2012
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • Allegre L, Debodinance P, Demattei C, Fabbro Peray P, Cayrac M, Fritel X, Courtieu C, Fatton B, de Tayrac R. Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial. Neurourol Urodyn. 2019 Nov;38(8):2242-2249. doi: 10.1002/nau.24125. Epub 2019 Jul 29.

    PubMed 31359498

Questions about this trial

What is this clinical trial studying?

A study testing UpholdTM LITE placement in people with Pelvic Organ Prolapse, run by Centre Hospitalier Universitaire de Nīmes at 13 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Apical anatomical success (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT01559168, 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 19 Nov 2025.

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