Overview

This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatment upholdtm lite placement
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date October 2012
End date July 2016
Trial size 121 participants
Trial identifier NCT01559168, 2011-A01705-36, LOCAL/2011/RdeT-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
upholdtm lite placement
Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.

Primary Outcomes

Measure
Apical anatomical success
time frame: 12 months
Anterior vaginal wall anatomical success
time frame: 12 months
Change from baseline in PFDI-20 scores
time frame: baseline to 12 lines

Secondary Outcomes

Measure
Anterior vaginal wall anatomical success
time frame: 6 months
Apical anatomical success
time frame: 6 weeks
Apical anatomical success
time frame: 6 months
Anterior vaginal wall anatomical success
time frame: 6 weeks
Change from baseline in PFDI-20 scores
time frame: baseline to 6 weeks
Change from baseline in PFDI-20 scores
time frame: baseline to 6 months
Change from baseline in PFIQ-7 scores
time frame: baseline to 6 weeks
Change from baseline in PFIQ-7 scores
time frame: baseline to 6 months
Change from baseline in PFIQ-7 scores
time frame: baseline to 12 months
Change from baseline in PISQ-12 scores
time frame: baseline to 6 months
Change from baseline in PISQ-12 scores
time frame: baseline to 12 months
length of hospital stay (days)
time frame: 6 weeks
Number of days necessary for return to normal activities
time frame: 6 weeks
Visual analog scale for post-operative pain
time frame: Day 1
Visual analog scale for post-operative pain
time frame: 6 weeks
Visual analog scale for post-operative pain
time frame: 6 months
Visual analog scale for post-operative pain
time frame: 12 months
Mesh related morbidity
time frame: Day 1
Mesh related morbidity
time frame: 6 weeks
Mesh related morbidity
time frame: 6 months
Mesh related morbidity
time frame: 12 months
Mesh contraction (cm)
time frame: 6 weeks
Mesh contraction (cm)
time frame: 6 months
Mesh contraction (cm)
time frame: 12 months
Patient satisfaction (PGI index) score
time frame: 6 weeks
Patient satisfaction (PGI index) score
time frame: 6 months
Patient satisfaction (PGI index) score
time frame: 12 months

Eligibility Criteria

Female participants at least 50 years old.

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

Additional Information

Official title Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial
Principal investigator Renaud de Tayrac, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.