Economic Evaluation of Prostatic Urethral Lift

NCT04726748 | Active Not Recruiting

• 1 other identifier: CHUBX 2019/12
• Study Type: observational
• Target: 1,360
• Locations: 1 country
• Sites: 6

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).

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incremental cost per Quality adjusted life year

  12 months after the date of surgical procedure

• Overall and specific urogenital healthcare consumptions

  during 3 years after surgical procedure date

• Benign prostatic hyperplasia retreatment

  12 months after surgical procedure date ; 36 months after surgical porcedure 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

Study Arms (3)

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; Procedure: Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts

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

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

Interventions

Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts PROCEDURE

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.

Transurethral Resection of the Prostate/laser cohort; Urolift cohort

Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts PROCEDURE

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.

National healthcare insurance system database (SNDS) cohort; Urolift cohort

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 participating to another interventional study on benign prostatic hyperplasia during the study.
• The SNDS cohort:
• male patient affiliated to a French health insurance system
• patient aged over 50 years

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Bordeaux PharmacoEpi: collaborator

Study Sites (6)

Hôpital Claude Huriez

Lille, 59037, France

Location

CHU de Montpellier

Montpellier, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Lyon Sud HCL

Pierre-Bénite, France

Location

Centre Hospitalier Universitaire de Bordeaux

Talence, France

Location

CHRU Hopitaux de Tours

Tours, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: April 8, 2021
• Primary Completion: December 9, 2023
• Study Completion: December 12, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)