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
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)
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)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Benign prostatic hyperplasia
8. Population under study
Age
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
9. Number of subjects
Estimated total number of subjects1360
Additional information
Urolift cohort: 80 patients with prostatic urethral lift surgery will be included.
TURP/laser cohort: 80 patients with a transurethral resection of the prostate or laser surgery (enucleation or vaporisation) will be included.
SNDS cohort: 1200 patients with any transurethral surgery (TURP/laser) will be included and randomly matched to patients of the Urolift cohort with ratio 5:1.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
SNDS NATIONAL CLAIMS DATABASE, France
Sources of data
Prospective patient-based data collection
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Economic evaluation
Primary scope : Economic evaluation
12. Main objective(s)
What is the main objective of the study?
The main objective is to assess the incremental cost-effectiveness ratio of prostatic urethral lift (Urolift) compared to transurethral surgery (TURP/laser) 4 months after initial hospitalization.
Are there primary outcomes?Yes
Incremental cost per avoided complication (based on Clavien Dindo classification) of Urolift compared with classic transurethral surgery (TURP/laser) 4 months after the surgical procedure.
Are there secondary outcomes?Yes
Incremental cost/QALY of Urolift compared to transurethral surgery(1year). Real cost of hospitalization for each surgery. Healthcare consumptions(4,12,36months). Benign prostatic hyperplasia retreatment(12,36months). Urinary symptoms, sexual side effects, quality of life(4,12months). Time to recovery/return to professional ativity(1,2,3,4months). Complications associated with surgery(4months).
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Prostatic urethral lift (Urolift) cohort: patients will be followed up to 1 year from surgery.
TURP/Laser cohort: patients will be followed up to 1 year from transurethral resection of the prostate or laser (enucleation or vaporisation) surgery.
Clinical data of the 2 cohorts will be enhanced with data from SNDS with 2-year history before surgery and a follow-up of 3 years.
15. Data analysis plan
Please provide a brief summary of the analysis method
SNDS patients will be matched to Urolift patients using a high dimensional disease risk score (hDRS) based on the 1-year SNDS information before surgery. Analyses will be done for each cohort according to matched treatment group: Description of populations - Comparison of baseline characteristics between Urolift and TURP/Laser cohorts and between Urolift and SNDS cohorts (before/after hDRS matching) - Estimation of cost-effectiveness ratios between Urolift and TURP/Laser cohorts (4 months,1 year) - Estimation of hospitalization cost for each surgery during hospital stay - Description of healthcare consumptions, disease retreatments, urinary symptoms, quality of life, time to recovery/return to professional activity, sexual side effects, associated complications - Comparison between Urolift and TURP/Laser cohorts and between Urolift and SNDS cohorts at 1, 3 years (intention-to-treat analysis using linear regression model and logistic regression model adjusted on potential confounding).
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
