Study type

Study topic

Disease /health condition

Study type

Non-interventional study

If ‘Not applicable’, further details on the study type

Interventional research (category 2 – minimal risks and contraints), cohort

If ‘other’, further details on the scope of the study

Economic evaluation

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Benign prostatic hyperplasia
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

1360
Study design details

Main study objective

The main objective is to assess the incremental cost-effectiveness ratio of prostatic urethral lift (Urolift) compared to transurethral surgery (TURP/laser) 4 months after initial hospitalization.

Outcomes

Incremental cost per avoided complication (based on Clavien Dindo classification) of Urolift compared with classic transurethral surgery (TURP/laser) 4 months after the surgical procedure.
Incremental cost/QALY of Urolift compared to transurethral surgery (1year).
Real cost of hospitalization for each surgery. Healthcare consumptions(4, 12, 36 months).
Benign prostatic hyperplasia retreatment(12, 36 months). Urinary symptoms, sexual side effects, quality of life (4, 12 months).
Time to recovery/return to professional activity (1, 2, 3, 4 months).
Complications associated with surgery (4 months).

Data analysis plan

SNDS patients will be matched to Urolift patients using a high dimensional disease risk score (hDRS) based on the 1-year SNDS information before surgery.
Analyses will be done for each cohort according to matched treatment group: Description of populations
- Comparison of baseline characteristics between Urolift and TURP/Laser cohorts and between Urolift and SNDS cohorts (before/after hDRS matching)
- Estimation of cost-effectiveness ratios between Urolift and TURP/Laser cohorts (4 months,1 year)
- Estimation of hospitalization cost for each surgery during hospital stay
- Description of healthcare consumptions, disease retreatments, urinary symptoms, quality of life, time to recovery/return to professional activity, sexual side effects, associated complications
- Comparison between Urolift and TURP/Laser cohorts and between Urolift and SNDS cohorts at 1, 3 years (intention-to-treat analysis using linear regression model and logistic regression model adjusted on potential confounding).