Economic Evaluation of Prostatic Urethral Lift (Urolift)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 1360
- Locations
- 6
- Primary Endpoint
- Incremental cost per avoided complication
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall and specific urogenital healthcare consumptions(during 3 years after surgical procedure date)
- Urinary incontinence evolution(Inclusion date (date of the surgical procedure completion) ; 4 months after surgical procedure)
- Sexual quality of life evolution(Inclusion date (date of the surgical procedure completion) ; 4 months, 12 months after surgical procedure)
- Incremental cost per Quality adjusted life year(12 months after the date of surgical procedure)
- Benign prostatic hyperplasia retreatment(12 months after surgical procedure date ; 36 months after surgical porcedure date)