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

NCT ID: NCT07144709

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 288 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2024-07-29

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Phytotherapy

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

Phytotherapy

Intervention Type: DRUG

Phytotherapy or alphablockers

Alpha-blockers

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

No interventions assigned to this group

Interventions

Phytotherapy

Phytotherapy or alphablockers

Intervention Type: DRUG

Other Intervention Names

Alpha-blockers

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kappa Santé

INDUSTRY

Sponsor Role: collaborator

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

EID

Role: STUDY_DIRECTOR

Pierre Fabre Laboratories

Locations

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

Medical Office of Specht MD

Lambersart, , France

Medical Office of Mesguich MD

Le Blanc-Mesnil, , France

Medical Office of Dassonval MD

Marles-les-Mines, , France

Medical Office of Cayron MD

Montpellier, , France

Medical Office of Chassagne MD

Montpellier, , France

Medical Office of Baranes MD

Paris, , France

Medical Office of Labregere MD

Paris, , France

Medical Office of Merlin MD

Raimbeaucourt, , France

Medical Office of Lemercier MD

Royan, , France

Medical Office of Margueritte MD

Six-Fours-les-Plages, , France

Maison de Santé MEDIVIE

Templeuve-en-Pévèle, , France

Medical Office of Demoulin MD

Val-de-Vesle, , France

Medical Office of David MD

Verzy, , France

Cs Vargas, Santander

Santander, Cantabria, Spain

C.S. San Jose

A Coruña, , Spain

C.S. Zona Ii

Albacete, , Spain

C.S. Aldea Moret

Cáceres, , Spain

C.S. Fuencarral

Madrid, , Spain

C.S. Mendiguchia

Madrid, , Spain

Centro Urología, Andrología Y Salud Sexual

Palma de Mallorca, , Spain

C.S. Rotxapea

Pamplona, , Spain

C.S. Soria Rural

Soria, , Spain

C.S. Laguna de Duero

Valladolid, , Spain

Cs Villamayor de Gallego

Zaragoza, , Spain

Countries

France; Spain

Other Identifiers

PierreFabreMed

Identifier Type: -

Identifier Source: org_study_id