Benign Prostatic HyperplasiaECOLIFTNCT04726748
Economic Evaluation of Prostatic Urethral Lift
An observational study of Benign Prostatic Hyperplasia, run by University Hospital, Bordeaux at 6 sites in France.
Trial summary
Prostatic urethral lift (Urolift) has been developed as a minimally invasive alternative to transurethral resection of the prostate with no need of general anaesthesia, less need of urinary catheter and less exposure to post-operative complication. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts and Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts
- Type of treatment
- Surgery or procedure
- How many people
- 1,360 participants
- Where
- 6 sitesFrance
- Study dates
- 8 Apr 2021to 12 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Adult, Older adult
Study population: Patients of the PUL and TURP/LASER cohorts will be identified in the SNDS through their NIR national identifier (if possible) or using a probabilistic linkage with age, hospital identifier (FINESS), date of hospitalization for the procedure and International Classification of Diseases-10 discharge diagnosis. Only patients with a 2-year history before the procedure and a 3-year follow-up after the procedure will be analysed.
Who may be able to join
- male patient aged over 50 years
- patient who experienced a PUL or TURP/Laser surgery in first line of treatment for a symptomatic BPH, with an International Prostatic Symptom Score > 13, a Peak urine flow rate < 12ml/sec on a voided volume >150ml a Prostate volume >30cc to <80 cc per ultrasound.
- patient affiliated to a French health insurance system
- male patient affiliated to a French health insurance system
- patient aged over 50 years
- patient who experienced a TURP/Laser surgery in first line of treatment for a symptomatic BPH in the same period as patients of the PUL and TURP/LASER cohorts.
Who cannot join
- Patient with current urinary retention, post void residual urine > 250ml,
- Patient with active urinary tract infection at time of treatment,
- Patient with previous Benign Prostatic Hyperplasia procedure,
- Patient with urethral conditions that may prevent insertion and delivery of device system into bladder,
- Patient with previous pelvic surgery or irradiation,
- Patient with history of neurogenic or atonic bladder,
Show all 19Show fewer
- Patient with biopsy of the prostate within the past 6 weeks,
- Patient with life expectancy estimated to be less than 1 year,
- Patient with history of prostate or bladder cancer,
- Patient with PSA>10ng/ml unless prostate biopsy is negative,
- Patient under guardianship or curatorship,
- Patient intending to move abroad within 1 year after inclusion will not be included either,
- Patient participating to another interventional study on benign prostatic hyperplasia during the study.
- The SNDS cohort:
- Patients hospitalized in one of the 6 investigational centers and patients with a previous BPH procedure,
- patient with a previous pelvic surgery or irradiation,
- patient with history of prostate or bladder cancer within the 2 previous years,
- patient with a biopsy of the prostate within the past 6 weeks,
- patient with a short life expectancy will not be included in the cohort.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Claude Huriez
Lille, 59037
CHU de Montpellier
Montpellier
Hôpital Cochin
Paris
Hôpital Lyon Sud HCL
Pierre-Bénite
Centre Hospitalier Universitaire de Bordeaux
Talence
CHRU Hopitaux de Tours
Tours
About this study
Official title: Economic Evaluation of Prostatic Urethral Lift (Urolift)
Prostatic urethral lift (Urolift) has been developed as a minimally invasive alternative to transurethral resection of the prostate 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 European Association of Urology 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).
Read the detailed description
Transurethral 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 European Association of Urology 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).
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts, Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohortsProcedure or surgery
Comparison between the PUL and the TURP/Laser cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:
- a linear regression model when it involves quantitative variables,
- a logistic regression model adjusted on potential confounding when it involves qualitative variables.
Comparison between the Prostatic urethral lift (PUL) and the SNDS cohortsProcedure or surgery
Comparison between the PUL and the SNDS cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:
- a linear regression model when it involves quantitative variables,
- a logistic regression model adjusted on potential confounding when it involves qualitative variables.
| Study group | Role | What they receive |
|---|---|---|
| Urolift cohort | 80 patients with prostatic urethral lift surgery will be included Receives: Procedure: Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts; Procedure: Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts | |
| Transurethral Resection of the Prostate/laser cohort | 80 patients with a transurethral resection of the prostate or laser surgery (enucleation or vaporisation) will be included. Receives: Procedure: Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts | |
| National healthcare insurance system database (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. Receives: Procedure: Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost per avoided complication
Incremental cost per avoided complication (based on Clavien Dindo classification) of Prostatic Urethral Lift compared with classic transurethral surgery (TURP/laser) 4 months after the surgical procedure.
Measured: 4 months after the date of surgical procedure
Secondary outcomes (5)
Incremental cost per Quality adjusted life year
The incremental cost per Quality adjusted life year of Prostatic Urethral Lift compared with classic transurethral surgery at 12 months.
Measured: 12 months after the date of surgical procedure
Overall and specific urogenital healthcare consumptions
Description of the overall and specific urogenital healthcare consumptions during the 3 years of follow-up.
Means will be compared between two independent groups using Student's t-test when normal distribution is followed (or Mann-Whitney's test when normal distribution is not followed)
Measured: during 3 years after surgical procedure date
Benign prostatic hyperplasia retreatment
Any dispensing of the following medications at 1 and 3 years after surgical procedure: alpha-blockers or 5-alpha-reductase inhibitors.
Measured: 12 months after surgical procedure date ; 36 months after surgical porcedure date
Urinary incontinence evolution
Urinary incontinence evolution between inclusion and 4 months after surgical procedure (Incontinence Severity Index (ISI)).
Measured: Inclusion date (date of the surgical procedure completion) ; 4 months after surgical procedure
Sexual quality of life evolution
Sexual quality of life evolution between inclusion, 4 months and 12 months after surgical procedure (IIEF5, Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD).
Measured: Inclusion date (date of the surgical procedure completion) ; 4 months, 12 months after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start8 Apr 2021
- Primary completion9 Dec 2023
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Bordeaux PharmacoEpi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726748
- Sponsor's protocol ID
- CHUBX 2019/12
- Acronym
- ECOLIFT
- Status last verified
- Jun 2025
- First submitted
- 19 Jan 2021
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of Prostatic Urethral Lift (Urolift)
- ClinicalTrials.gov ID
- NCT04726748
- Acronym / sponsor ID
- ECOLIFT / CHUBX 2019/12
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,360 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Bordeaux PharmacoEpi
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 9 Dec 2023 (actual)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostatic urethral lift (Urolift) has been developed as a minimally invasive alternative to transurethral resection of the prostate 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 European Association of Urology 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).
Detailed description
Transurethral 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 European Association of Urology 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urolift cohort | – | Procedure: Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts, Procedure: Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts80 patients with prostatic urethral lift surgery will be included |
| Transurethral Resection of the Prostate/laser cohort | – | Procedure: Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts80 patients with a transurethral resection of the prostate or laser surgery (enucleation or vaporisation) will be included. |
| National healthcare insurance system database (SNDS) cohort | – | Procedure: Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts1200 patients with any transurethral surgery (TURP/laser) will be included and randomly matched to patients of the Urolift cohort with ratio 5:1. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients of the PUL and TURP/LASER cohorts will be identified in the SNDS through their NIR national identifier (if possible) or using a probabilistic linkage with age, hospital identifier (FINESS), date of hospitalization for the procedure and International Classification of Diseases-10 discharge diagnosis. Only patients with a 2-year history before the procedure and a 3-year follow-up after the procedure will be analysed.
Key inclusion criteria (6 listed)
- male patient aged over 50 years
- patient who experienced a PUL or TURP/Laser surgery in first line of treatment for a symptomatic BPH, with an International Prostatic Symptom Score > 13, a Peak urine flow rate < 12ml/sec on a voided volume >150ml a Prostate volume >30cc to <80 cc per ultrasound.
- patient affiliated to a French health insurance system
- male patient affiliated to a French health insurance system
- patient aged over 50 years
Key exclusion criteria (19 listed)
- Patient with current urinary retention, post void residual urine > 250ml,
- Patient with active urinary tract infection at time of treatment,
- Patient with previous Benign Prostatic Hyperplasia procedure,
- Patient with urethral conditions that may prevent insertion and delivery of device system into bladder,
- Patient with previous pelvic surgery or irradiation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohortsComparison between the PUL and the TURP/Laser cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using: * a linear regression model when it involves quantitative variables, * a logistic regression model adjusted on potential confounding when it involves qualitative variables. | Procedure or surgery | Transurethral Resection of the Prostate/laser cohort, Urolift cohort |
| Comparison between the Prostatic urethral lift (PUL) and the SNDS cohortsComparison between the PUL and the SNDS cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using: * a linear regression model when it involves quantitative variables, * a logistic regression model adjusted on potential confounding when it involves qualitative variables. | Procedure or surgery | National healthcare insurance system database (SNDS) cohort, Urolift cohort |
Primary outcome
Incremental cost per avoided complication
Time frame: 4 months after the date of surgical procedure
Incremental cost per avoided complication (based on Clavien Dindo classification) of Prostatic Urethral Lift compared with classic transurethral surgery (TURP/laser) 4 months after the surgical procedure.
5 secondary outcomes
Incremental cost per Quality adjusted life year
Time frame: 12 months after the date of surgical procedure
Overall and specific urogenital healthcare consumptions
Time frame: during 3 years after surgical procedure date
Benign prostatic hyperplasia retreatment
Time frame: 12 months after surgical procedure date ; 36 months after surgical porcedure date
Urinary incontinence evolution
Time frame: Inclusion date (date of the surgical procedure completion) ; 4 months after surgical procedure
Sexual quality of life evolution
Time frame: Inclusion date (date of the surgical procedure completion) ; 4 months, 12 months after surgical procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by University Hospital, Bordeaux at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost per avoided complication (time frame: 4 months after the date of surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.