Trials Sponsors Conditions Drugs Pricing

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9) M6
Mean difference in BPHQOL9 scores between baseline and M6, by group of treatment (PT and AB). For BPHQOL9, the total score can range from 0 to 90 (sum of all 9 items). A higher score means a better quality of life.
6 months

Secondary Outcomes (5)

Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9), M6
6 months
Quality of life Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9)
6 months
Urinary symptoms profiles
6 months
Sexual Fonction
6 months
Safety (Adverse events)
6 months

Other Outcomes (1)

Correlation
6 months

Study Arms (2)

Phytotherapy

Patients initiating a first-line phytotherapy treatment for LUTS/BPH in monotherapy

Drug: Phytotherapy

Alpha-blockers

Patients initiating a first-line alpha-blockers treatment for LUTS/BPH in monotherapy

Interventions

PhytotherapyDrug

Phytotherapy or alphablockers

Also known as: Alpha-blockers

Phytotherapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Participating sites will be encouraged to propose the study to all patients meeting the eligibility criteria, in a consecutive manner, when they come for consultation, in order to minimize bias in patient selection.Each investigator site will include the samenumber of patients initiating PT and initiating AB.Treatment choice should be made by the investigator as routine practice. No medical therapy is required for this study.Investigators should ensure that IPSS total score meets the eligibility criteria before enrolling patients in the study.

You may qualify if:

Sponsors & Collaborators

Pierre Fabre Medicament
Industrylead
Kappa Santé
Industrycollaborator

Study Sites (31)

Medical Office of Delsart MD

Bersée, France

Medical Office of Breton MD

Béziers, France

Medical Office of Guiu MD

Ferrals-les-Corbières, France

Medical Office of Patron MD

Gap, France

Medical Office of Coulon MD

Giromagny, France

Medical Office of Dassa MD

Istres, France

Medical Office of Rigaud MD

Lamagistère, France

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

PhytotherapyAdrenergic alpha-Antagonists

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAdrenergic AntagonistsAdrenergic Agents

Study Officials

EID
Pierre Fabre Laboratories
STUDY DIRECTOR

Enrollment

288 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 27, 2025

Study Start

June 22, 2022

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (1)

Study Arms (2)

Phytotherapy

Alpha-blockers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (1)

Study Arms (2)

Phytotherapy

Alpha-blockers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (31)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations