Status:
COMPLETED
A 6-months Observational Study to Evaluate the Quality of Life of Patients Treated With Phytotherapy or Alpha-blockers for Benign Prostatic Hyperplasia
Lead Sponsor:
Pierre Fabre Medicament
Collaborating Sponsors:
Kappa Santé
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Brief Summary
This is a prospective, multicentre, non-interventional study, conducted in France and Spain, in primary care practices and designed to assess the QoL of patients under phytotherapy or alpha-blockers f...
Detailed Description
Any patient with moderate to severe LUTS/BPH initiating treatment with PT or AB during the inclusion period will be invited to participate in the study. Per usual practice, the physician will prescrib...
Eligibility Criteria
Inclusion
- Male patient
- Age ≥ 40 years at the time of enrolment
- Diagnosed with moderate to severe LUTS/BPH (IPSS ≥ 12)
- Initiating a first-line PT or AB treatment for LUTS/BPH in monotherapy
- Provided informed consent or non-opposition to study inclusion, and for the use of data, according to local regulations
Exclusion
- Underwent prostate surgery or urinary tract surgery
- Diagnosed with one or several other diseases involving urinary function or prostate Diagnosed with BPH with complications (recurrent urinary tract infection, recurrent acute urinary retention, bladder calculus, bladder diverticulum, hydronephrosis, overflow incontinence, recurrent hematuria, obstructive renal failure) Participating in interventional trial on any investigational drug at time of inclusion Under treatment of the urinary functions
Key Trial Info
Start Date :
June 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 29 2024
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT07144709
Start Date
June 22 2022
End Date
July 29 2024
Last Update
August 27 2025
Active Locations (31)
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1
Medical Office of Delsart MD
Bersée, France
2
Medical Office of Breton MD
Béziers, France
3
Medical Office of Guiu MD
Ferrals-les-Corbières, France
4
Medical Office of Patron MD
Gap, France