Economic Evaluation of Prostatic Urethral Lift
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Procedure: Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohortsProcedure: Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts
- Registration Number
- NCT04726748
- Lead Sponsor
- University Hospital, Bordeaux
- Brief 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. 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 1360
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Transurethral Resection of the Prostate/laser cohort Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts 80 patients with a transurethral resection of the prostate or laser surgery (enucleation or vaporisation) will be included. Urolift cohort Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts 80 patients with prostatic urethral lift surgery will be included Urolift cohort Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts 80 patients with prostatic urethral lift surgery will be included National healthcare insurance system database (SNDS) cohort Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts 1200 patients with any transurethral surgery (TURP/laser) will be included and randomly matched to patients of the Urolift cohort with ratio 5:1.
- Primary Outcome Measures
Name Time Method Incremental cost per avoided complication 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.
- Secondary Outcome Measures
Name Time Method Overall and specific urogenital healthcare consumptions during 3 years after surgical procedure date 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)Urinary incontinence evolution Inclusion date (date of the surgical procedure completion) ; 4 months after surgical procedure Urinary incontinence evolution between inclusion and 4 months after surgical procedure (Incontinence Severity Index (ISI)).
Sexual quality of life evolution Inclusion date (date of the surgical procedure completion) ; 4 months, 12 months after surgical procedure 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).
Incremental cost per Quality adjusted life year 12 months after the date of surgical procedure The incremental cost per Quality adjusted life year of Prostatic Urethral Lift compared with classic transurethral surgery at 12 months.
Benign prostatic hyperplasia retreatment 12 months after surgical procedure date ; 36 months after surgical porcedure date Any dispensing of the following medications at 1 and 3 years after surgical procedure: alpha-blockers or 5-alpha-reductase inhibitors.
Trial Locations
- Locations (6)
Hôpital Claude Huriez
🇫🇷Lille, France
CHU de Montpellier
🇫🇷Montpellier, France
Hôpital Cochin
🇫🇷Paris, France
Hôpital Lyon Sud HCL
🇫🇷Pierre-Bénite, France
Centre Hospitalier Universitaire de Bordeaux
🇫🇷Talence, France
CHRU Hopitaux de Tours
🇫🇷Tours, France