Status: Planned First registered on: 20/02/2020
Last updated on: 20/02/2020
1. Study identification
EU PAS Register NumberEUPAS33766
Official titleEconomic evaluation of Prostatic Urethral Lift (Urolift)
Study title acronymECOLIFT
Study typeOther: Interventional research (category 2 – minimal risks and contraints)
Brief description of the studyTransurethral surgery such as transurethral resection of the prostate (TURP), laser enucleation or laser vaporisation, is the first line surgical treatment for bladder outlet obstruction secondary to benign prostatic hyperplasia. Even if bipolar and laser surgery have improved surgical outcomes in terms of length of hospital stay and post-operative complications, these procedures remain associated with a significant amount of infectious and bleeding complications, as well as with some persistent side effects such as sexual dysfunction and urinary incontinence. Prostatic urethral lift (Urolift) has been developed as a minimally invasive alternative to TURP with no need of general anaesthesia, less need of urinary catheter and less exposure to post-operative complication. Its efficacy and safety have been assessed by 2 clinical randomized trials with evidence of urinary symptom improvement remaining inferior to TURP but durable for 5 years. Urolift preserved overall quality of life better than TURP. Urolift has been recommended by the EAU guidelines and recognized by French authorities but cannot be financed by the hospital itself. Reimbursement of the implants by healthcare system is therefore needed for the distribution of Urolift in France. The additional cost of the implants could be compensated by a reduced length of hospital stay and a lower rate of post-operative complications inducing healthcare expenditures. This study aims to assess if Urolift could be a cost-effective therapeutic strategy compared to transurethral surgery with 2 phases design: a field study comparing patients treated with Urolift to those treated with TURP/laser during 1 year follow-up, and an additional study comparing healthcare consumptions during 3 years follow-up between each group using data of the French National Claims Database (SNDS database).
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableNot applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameUniversity hospital of Bordeaux
Centre locationBordeaux, France
Details of (Primary) lead investigator
Title Professor
Last name ROBERT
First name Grégoire
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?7

Bordeaux PharmacoEpi
University Hospital of Bordeaux, Bordeaux, France
University Hospital of Lyon, Lyon, France
University Hospital of Montpellier, Montpellier, France
University Hospital of Lille, Lille, France
Hôpital Cochin - APHP, Paris, France
University Hospital of Tours, Tours, France
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/02/2020
Start date of data collection01/06/2020
Start date of data analysis01/03/2022
Date of interim report, if expected30/09/2024
Date of final study report30/09/2026
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNEOTRACT, INC100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name ROBERT
First name Grégoire
Address line 1Bordeaux University hospital
Address line 2Urologic surgery and renal transplantation 
Address line 3Hôpital Pellegrin, Place Amélie Raba-Léon 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33556795547 
Alternative phone number 
Fax number (incl. country code) 
Email address gregoire.robert@chu-bordeaux.fr
Public Enquiries
Title Professor 
Last name ROBERT 
First name Grégoire 
Address line 1Bordeaux University hospital 
Address line 2Urologic surgery and renal transplantation 
Address line 3Hôpital Pellegrin, Place Amélie Raba-Léon 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33556795547 
Alternative phone number 
Fax number (incl. country code) 
Email address gregoire.robert@chu-bordeaux.fr 
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