Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

NCT ID: NCT01559168

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-10-12

Brief 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) and no reintervention for recurrent prolapse of the anterior or apical compartment.

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

UpholdTM LITE placement

Intervention Type: DEVICE

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

Interventions

UpholdTM LITE placement

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renaud de Tayrac, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CH Camille Guérin

Châtellerault, , France

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, , France

CH de Dunkerque

Dunkirk, , France

CH de Gonesse

Gonesse, , France

CHRU de Lille - Hôpital Jeanne de Flandre

Lille, , France

CHRU de Lyon - Hôpital de la Croix Rousse

Lyon, , France

APHM - Hôpital de la Conception

Marseille, , France

Clinique Beau Soleil

Montpellier, , France

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

CH Louis Giorgi

Orange, , France

CHU de Poitiers

Poitiers, , France

Hôpital Foch

Suresnes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 31359498 (View on PubMed)

Other Identifiers

2011-A01705-36

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2011/RdeT-04

Identifier Type: -

Identifier Source: org_study_id