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

Pierre Fabre

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Phytotherapy

Study type

Observational

Funder types

Industry

Identifiers

NCT07144709

PierreFabreMed

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

288 patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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