MedTrace Logo

Economic Evaluation of Prostatic Urethral Lift

NCT04726748 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1360

Last updated 2025-06-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Bordeaux PharmacoEpi

    collaborator OTHER

  • University Hospital, Bordeaux

    lead OTHER

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2023-12-09
Completion
2025-12-12

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04726748 on ClinicalTrials.gov