Clinical trial NCT01559168: Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse
Official title: Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 121
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Apical anatomical success
timeFrame: 12 months
measure: Anterior vaginal wall anatomical success
timeFrame: 12 months
measure: Change from baseline in PFDI-20 scores
timeFrame: baseline to 12 lines
Secondary outcomes:
measure: Anterior vaginal wall anatomical success
timeFrame: 6 months
measure: Apical anatomical success
timeFrame: 6 weeks
measure: Apical anatomical success
timeFrame: 6 months
measure: Anterior vaginal wall anatomical success
timeFrame: 6 weeks
measure: Change from baseline in PFDI-20 scores
timeFrame: baseline to 6 weeks
measure: Change from baseline in PFDI-20 scores
timeFrame: baseline to 6 months
measure: Change from baseline in PFIQ-7 scores
timeFrame: baseline to 6 weeks
measure: Change from baseline in PFIQ-7 scores
timeFrame: baseline to 6 months
measure: Change from baseline in PFIQ-7 scores
timeFrame: baseline to 12 months
measure: Change from baseline in PISQ-12 scores
timeFrame: baseline to 6 months
measure: Change from baseline in PISQ-12 scores
timeFrame: baseline to 12 months
measure: length of hospital stay (days)
timeFrame: 6 weeks
measure: Number of days necessary for return to normal activities
timeFrame: 6 weeks
measure: Visual analog scale for post-operative pain
timeFrame: Day 1
measure: Visual analog scale for post-operative pain
timeFrame: 6 weeks
measure: Visual analog scale for post-operative pain
timeFrame: 6 months
measure: Visual analog scale for post-operative pain
timeFrame: 12 months
measure: Mesh related morbidity
timeFrame: Day 1
measure: Mesh related morbidity
timeFrame: 6 weeks
measure: Mesh related morbidity
timeFrame: 6 months
measure: Mesh related morbidity
timeFrame: 12 months
measure: Mesh contraction (cm)
timeFrame: 6 weeks
measure: Mesh contraction (cm)
timeFrame: 6 months
measure: Mesh contraction (cm)
timeFrame: 12 months
measure: Patient satisfaction (PGI index) score
timeFrame: 6 weeks
measure: Patient satisfaction (PGI index) score
timeFrame: 6 months
measure: Patient satisfaction (PGI index) score
timeFrame: 12 months
Other outcomes:
Locations:
city: Châtellerault Cedex
country: France
facility: CH Camille Guérin
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Estaing
city: Dunkerque
country: France
facility: CH de Dunkerque
city: Gonesse
country: France
facility: CH de Gonesse
city: Lille Cedex
country: France
facility: CHRU de Lille - Hôpital Jeanne de Flandre
city: Lyon Cedex 4
country: France
facility: CHRU de Lyon - Hôpital de la Croix Rousse
city: Marseille Cedex 5
country: France
facility: APHM - Hôpital de la Conception
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Orange
country: France
facility: CH Louis Giorgi
city: Poitiers
country: France
facility: CHU de Poitiers
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Renaud de Tayrac, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.