Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

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: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Device: UpholdTM LITE placement

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: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

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 Nimes - Hopital Universitaire Caremeau
  • Orange, France, 84106
    • CH Louis Giorgi
  • Poitiers, France, 86021
    • CHU De Poitiers
  • Suresnes, France, 92150
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Apical anatomical success	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	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		baseline to 12 lines

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months
Apical anatomical success	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	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	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		baseline to 6 weeks
Change from baseline in PFDI-20 scores		baseline to 6 months
Change from baseline in PFIQ-7 scores		baseline to 6 weeks
Change from baseline in PFIQ-7 scores		baseline to 6 months
Change from baseline in PFIQ-7 scores		baseline to 12 months
Change from baseline in PISQ-12 scores		baseline to 6 months
Change from baseline in PISQ-12 scores		baseline to 12 months
length of hospital stay (days)		6 weeks
Number of days necessary for return to normal activities		6 weeks
Visual analog scale for post-operative pain	score ranging from 0.0 to 10.0	Day 1
Visual analog scale for post-operative pain	score ranging from 0.0 to 10.0	6 weeks
Visual analog scale for post-operative pain	score ranging from 0.0 to 10.0	6 months
Visual analog scale for post-operative pain	score ranging from 0.0 to 10.0	12 months
Mesh related morbidity	Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)	Day 1
Mesh related morbidity	Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)	6 weeks
Mesh related morbidity	Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)	6 months
Mesh related morbidity	Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)	12 months
Mesh contraction (cm)	Mesh contraction as determined by ultrasound measurement (cm)	6 weeks
Mesh contraction (cm)	Mesh contraction as determined by ultrasound measurement (cm)	6 months
Mesh contraction (cm)	Mesh contraction as determined by ultrasound measurement (cm)	12 months
Patient satisfaction (PGI index) score		6 weeks
Patient satisfaction (PGI index) score		6 months
Patient satisfaction (PGI index) score		12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 12, 2016
• Study Completion (Actual): October 12, 2016

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimated): March 21, 2012

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse
• Other Study ID Numbers: LOCAL/2011/RdeT-04; 2011-A01705-36 (Other Identifier: ANSM)