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

NCT07144709 | Completed FDA Drug

• 1 other identifier: PierreFabreMed
• Study Type: observational
• Target: 288
• Locations: 2 countries
• Sites: 31

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

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

Phytotherapy DRUG

Phytotherapy or alphablockers

Also known as: Alpha-blockers

Phytotherapy

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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:

• 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

You may not qualify if:

• Underwent prostate surgery or urinary tract surgery

Sponsors & Collaborators

• Pierre Fabre Medicament: lead
• Kappa Santé: collaborator

Study Sites (31)

Medical Office of Delsart MD

Bersée, France

Location

Medical Office of Breton MD

Béziers, France

Location

Medical Office of Guiu MD

Ferrals-les-Corbières, France

Location

Medical Office of Patron MD

Gap, France

Location

Medical Office of Coulon MD

Giromagny, France

Location

Medical Office of Dassa MD

Istres, France

Location

Medical Office of Rigaud MD

Lamagistère, France

Location

Medical Office of Specht MD

Lambersart, France

Location

Medical Office of Mesguich MD

Le Blanc-Mesnil, France

Location

Medical Office of Dassonval MD

Marles-les-Mines, France

Location

Medical Office of Cayron MD

Montpellier, France

Location

Medical Office of Chassagne MD

Montpellier, France

Location

Medical Office of Baranes MD

Paris, France

Location

Medical Office of Labregere MD

Paris, France

Location

Medical Office of Merlin MD

Raimbeaucourt, France

Location

Medical Office of Lemercier MD

Royan, France

Location

Medical Office of Margueritte MD

Six-Fours-les-Plages, France

Location

Maison de Santé MEDIVIE

Templeuve-en-Pévèle, France

Location

Medical Office of Demoulin MD

Val-de-Vesle, France

Location

Medical Office of David MD

Verzy, France

Location

Cs Vargas, Santander

Santander, Cantabria, Spain

Location

C.S. San Jose

A Coruña, Spain

Location

C.S. Zona Ii

Albacete, Spain

Location

C.S. Aldea Moret

Cáceres, Spain

Location

C.S. Fuencarral

Madrid, Spain

Location

C.S. Mendiguchia

Madrid, Spain

Location

Centro Urología, Andrología Y Salud Sexual

Palma de Mallorca, Spain

Location

C.S. Rotxapea

Pamplona, Spain

Location

C.S. Soria Rural

Soria, Spain

Location

C.S. Laguna de Duero

Valladolid, Spain

Location

Cs Villamayor de Gallego

Zaragoza, Spain

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Phytotherapy; Adrenergic alpha-Antagonists

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• EID

  Pierre Fabre Laboratories

  STUDY DIRECTOR

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
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (11); FR (20)