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NCT04726748

Economic Evaluation of Prostatic Urethral Lift

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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).

Official title: Economic Evaluation of Prostatic Urethral Lift (Urolift)

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1360

Start Date

2021-04-08

Completion Date

2025-12-12

Last Updated

2025-06-22

Healthy Volunteers

Not specified

Conditions

Benign Prostatic Hyperplasia

Interventions

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.

● 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.

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