Clinical trial NCT04726748: Economic Evaluation of Prostatic Urethral Lift
Official title: Economic Evaluation of Prostatic Urethral Lift (Urolift)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Bordeaux PharmacoEpi
First posted: 2021-01-27
Enrollment: 1360
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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).

Eligibility criteria: ● The PUL and TURP/LASER cohorts:

Inclusion criteria:

* 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

Exclusion criteria:

* 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,
* 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:

Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Incremental cost per avoided complication
timeFrame: 4 months after the date of surgical procedure
Secondary outcomes:
measure: Incremental cost per Quality adjusted life year
timeFrame: 12 months after the date of surgical procedure
measure: Overall and specific urogenital healthcare consumptions
timeFrame: during 3 years after surgical procedure date
measure: Benign prostatic hyperplasia retreatment
timeFrame: 12 months after surgical procedure date ; 36 months after surgical porcedure date
measure: Urinary incontinence evolution
timeFrame: Inclusion date (date of the surgical procedure completion) ; 4 months after surgical procedure
measure: Sexual quality of life evolution
timeFrame: Inclusion date (date of the surgical procedure completion) ; 4 months, 12 months after surgical procedure
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: Hôpital Cochin
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud HCL
city: Talence
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Tours
country: France
facility: CHRU Hopitaux de Tours
Study officials:
References: