Economic Evaluation of Prostatic Urethral Lift

Benign Prostatic Hyperplasia Clinical Trial

— ECOLIFT  

Official title:

Economic Evaluation of Prostatic Urethral Lift (Urolift)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726748
• Other study ID #: CHUBX 2019/12
• Status: Recruiting
• Start date: April 8, 2021
• Est. completion date: June 2026

Study information

• Verified date: April 2023
• Source: University Hospital, Bordeaux
• Contact: Grégoire Robert
• Phone: 05.57.82.06.87
• Email: gregoire.robert[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 1360
• Est. completion date: June 2026
• Est. primary completion date: December 2024
• Gender: Male
• Age group: 50 Years and older

Eligibility

? 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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts
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 cohorts
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.

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Bordeaux PharmacoEpi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months after the date of surgical procedure
Secondary	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.	12 months after the date of surgical procedure
Secondary	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)	during 3 years after surgical procedure date
Secondary	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.	12 months after surgical procedure date ; 36 months after surgical porcedure date
Secondary	Urinary incontinence evolution	Urinary incontinence evolution between inclusion and 4 months after surgical procedure (Incontinence Severity Index (ISI)).	Inclusion date (date of the surgical procedure completion) ; 4 months after surgical procedure
Secondary	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).	Inclusion date (date of the surgical procedure completion) ; 4 months, 12 months after surgical procedure