Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

NCT01559168 | Completed

• 2 other identifiers: LOCAL/2011/RdeT-042011-A01705-36
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 13

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (27)

• Anterior vaginal wall anatomical success

  6 months

• Apical anatomical success

  6 weeks

• Apical anatomical success

  6 months

• Anterior vaginal wall anatomical success

  6 weeks

• Change from baseline in PFDI-20 scores

  baseline to 6 weeks

Study Arms (1)

Prolapse patients recieving UpHold LITE

EXPERIMENTAL

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

Interventions

UpholdTM LITE placement DEVICE

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

Prolapse patients recieving UpHold LITE

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (13)

CH Camille Guérin

Châtellerault, 86106, France

Location

CHU de Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, 63003, France

Location

CH de Dunkerque

Dunkirk, 59385, France

Location

CH de Gonesse

Gonesse, 95500, France

Location

CHRU de Lille - Hôpital Jeanne de Flandre

Lille, 59037, France

Location

CHRU de Lyon - Hôpital de la Croix Rousse

Lyon, 69317, France

Location

APHM - Hôpital de la Conception

Marseille, 13385, France

Location

Clinique Beau Soleil

Montpellier, 34070, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CH Louis Giorgi

Orange, 84106, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (1)

• 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.

  PMID: 31359498 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Renaud de Tayrac, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: October 1, 2012
• Primary Completion: October 12, 2016
• Study Completion: October 12, 2016
• Last Updated: November 19, 2025

Record last verified: 2017-01

Locations

FR (13)