Economic Evaluation of Prostatic Urethral Lift (ECOLIFT)

Economic Evaluation of Prostatic Urethral Lift (Urolift)

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).

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts; Procedure: Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts

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).

• Study Type: Observational
• Enrollment (Estimated): 1360

Contacts and Locations

• Study Contact: Name: Grégoire Robert; Phone Number: 05.57.82.06.87; Email: gregoire.robert@chu-bordeaux.fr
• Study Contact Backup: Name: Meric BENBOUJEMA; Phone Number: 05.57.82.06.87; Email: meric.ben-boujema@chu-bordeaux.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hopital Claude Huriez
    • Contact: Arnauld VILLERS; Phone Number: 03 20 44 42 35; Email: arnauldvillers@me.com
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier
    • Contact: Thibaut MUREZ; Email: t-murez@chu-montpellier.fr
  • Paris, France
    • Recruiting
    • Hôpital Cochin
    • Contact: Nicolas BARY DELONGCHAMPS; Phone Number: 0158412783; Email: nicolas.barrydelongchamps@aphp.fr
  • Pierre-Bénite, France
    • Recruiting
    • Hôpital Lyon Sud HCL
    • Contact: Alain RUFFION; Email: alain.ruffion@chu-lyon.fr
  • Talence, France
    • Recruiting
    • Centre Hospitalier Universitaire de Bordeaux
    • Contact: Grégoire ROBERT; Phone Number: 05.57.82.06.87
    • Contact: Meric BEN BOUJEMA; Phone Number: 05.57.82.06.87; Email: meric.ben-boujema@chu-bordeaux.fr
  • Tours, France
    • Recruiting
    • CHRU Hôpitaux De Tours
    • Contact: Franck BRUYERE; Phone Number: 0247473917; Email: F.BRUYERE@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

● 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Urolift cohort; 80 patients with prostatic urethral lift surgery will be included	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.; Procedure: 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.
Transurethral Resection of the Prostate/laser cohort; 80 patients with a transurethral resection of the prostate or laser surgery (enucleation or vaporisation) will be included.	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.
National healthcare insurance system database (SNDS) cohort; 1200 patients with any transurethral surgery (TURP/laser) will be included and randomly matched to patients of the Urolift cohort with ratio 5:1.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Bordeaux PharmacoEpi

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CHUBX 2019/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No