Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: UpholdTM LITE placement

Study type: Interventional

Funder types: Other

Identifiers

NCT01559168

2011-A01705-36 (Other Identifier)

LOCAL/2011/RdeT-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

Prolapse patients recieving UpHold LITE

Experimental group

Description:

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.

Treatment:

Device: UpholdTM LITE placement