Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse
- Conditions
- Pelvic Organ Prolapse
- Interventions
- Device: UpholdTM LITE placement
- Registration Number
- NCT01559168
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 121
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prolapse patients recieving UpHold LITE UpholdTM LITE placement 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.
- Primary Outcome Measures
Name Time Method Anterior vaginal wall anatomical success 12 months Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba \< = stage 1 per POP-Q scoring (ICS)
Change from baseline in PFDI-20 scores baseline to 12 lines Apical anatomical success 12 months Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C \<= stage 1 per POP-Q scoreing (ICS)
- Secondary Outcome Measures
Name Time Method Anterior vaginal wall anatomical success 6 weeks Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba \< = stage 1 per POP-Q scoring (ICS)
Change from baseline in PFDI-20 scores baseline to 6 months Number of days necessary for return to normal activities 6 weeks Change from baseline in PFIQ-7 scores baseline to 12 months length of hospital stay (days) 6 weeks Mesh contraction (cm) 12 months Mesh contraction as determined by ultrasound measurement (cm)
Patient satisfaction (PGI index) score 12 months Apical anatomical success 6 months Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C \<= stage 1 per POP-Q scoreing (ICS)
Visual analog scale for post-operative pain 12 months score ranging from 0.0 to 10.0
Mesh related morbidity 12 months Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia)
Change from baseline in PISQ-12 scores baseline to 12 months
Trial Locations
- Locations (13)
APHM - Hôpital de la Conception
🇫🇷Marseille Cedex 5, France
CHU de Poitiers
🇫🇷Poitiers, France
Hôpital Foch
🇫🇷Suresnes, France
CH Camille Guérin
🇫🇷Châtellerault Cedex, France
CHU de Clermont Ferrand - Hôpital Estaing
🇫🇷Clermont Ferrand, France
CH de Dunkerque
🇫🇷Dunkerque, France
CH de Gonesse
🇫🇷Gonesse, France
CHRU de Lille - Hôpital Jeanne de Flandre
🇫🇷Lille Cedex, France
Clinique Beau Soleil
🇫🇷Montpellier, France
CHU de Montpellier - Hôpital Lapeyronie
🇫🇷Montpellier, France
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France
CH Louis Giorgi
🇫🇷Orange, France
CHRU de Lyon - Hôpital de la Croix Rousse
🇫🇷Lyon Cedex 4, France