Study identification

PURI

https://redirect.ema.europa.eu/resource/43662

EU PAS number

EUPAS33766

Study ID

43662

Official title and acronym

Economic evaluation of Prostatic Urethral Lift (Urolift) (ECOLIFT)

DARWIN EU® study

No

Study countries

France

Study 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 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).

Study status

Ongoing
Research institution and networks

Institutions

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

Contact details

Grégoire ROBERT

Primary lead investigator
Study timelines

Date when funding contract was signed

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Actual:

Study start date

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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

NEOTRACT, INC
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable