A 6-months Observational Study to Evaluate the Quality of Life of Patients Treated With Phytotherapy or Alpha-blockers for Benign Prostatic Hyperplasia

A 6-months Prospective, Observational Study to Evaluate the Quality of Life of Patients Treated With Phytotherapy or Alpha-blockersfor Benign Prostatic Hyperplasia

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 for LUTS/BPH. The study will not provide or recommend any treatment or procedure.

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 prescribe a treatment independently of the study. Patients will be consecutively enrolled in each of the 2 groups (PT or AB), regardless of the number of patients already enrolled in the other group. An average of 6 patients per General Practitioner (GP) is expected, i.e. 3 patients in each group. A GP who has reached 3 patients in a group will continue to recruit in the second group until reaching 2 groups of 3 patients. Once the two groups of 3 patients have been completed, the inclusions may be re-opened following the same procedure.

Inclusion Criteria:

• 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 Criteria:

• 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