Status:
ACTIVE_NOT_RECRUITING
Economic Evaluation of Prostatic Urethral Lift
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Bordeaux PharmacoEpi
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
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 a...
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 ...
Eligibility Criteria
Inclusion
- ● 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.
Exclusion
Key Trial Info
Start Date :
April 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 12 2025
Estimated Enrollment :
1360 Patients enrolled
Trial Details
Trial ID
NCT04726748
Start Date
April 8 2021
End Date
December 12 2025
Last Update
June 22 2025
Active Locations (6)
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1
Hôpital Claude Huriez
Lille, France, 59037
2
CHU de Montpellier
Montpellier, France
3
Hôpital Cochin
Paris, France
4
Hôpital Lyon Sud HCL
Pierre-Bénite, France