NCT07144709

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 288 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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

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 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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Phytotherapy	Phytotherapy or alphablockers

Timeline

• Start date: 2022-06-22
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

31 sites across 2 countries: France, Spain

Regulatory

• FDA-regulated drug study