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Benign Prostatic HyperplasiaPERQoLNCT07144709

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

An observational study of Benign Prostatic Hyperplasia, run by Pierre Fabre Medicament at 31 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Benign Prostatic Hyperplasia
What is being tested?
Phytotherapy
How many people
288 participants
Where
31 sitesin 2 countries
Study dates
22 Jun 2022to 29 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

31 sites in 2 countries.

31 sites in 2 countries

France20 sites

  • Medical Office of Delsart MD

    Bersée

  • Medical Office of Breton MD

    Béziers

  • Medical Office of Guiu MD

    Ferrals-les-Corbières

  • Medical Office of Patron MD

    Gap

  • Medical Office of Coulon MD

    Giromagny

  • Medical Office of Dassa MD

    Istres

  • Medical Office of Rigaud MD

    Lamagistère

  • Medical Office of Specht MD

    Lambersart

  • Medical Office of Mesguich MD

    Le Blanc-Mesnil

  • Medical Office of Dassonval MD

    Marles-les-Mines

  • Medical Office of Cayron MD

    Montpellier

  • Medical Office of Chassagne MD

    Montpellier

  • Medical Office of Baranes MD

    Paris

  • Medical Office of Labregere MD

    Paris

  • Medical Office of Merlin MD

    Raimbeaucourt

  • Medical Office of Lemercier MD

    Royan

  • Medical Office of Margueritte MD

    Six-Fours-les-Plages

  • Maison de Santé MEDIVIE

    Templeuve-en-Pévèle

  • Medical Office of Demoulin MD

    Val-de-Vesle

  • Medical Office of David MD

    Verzy

Other trials in France

Spain11 sites

  • C.S. San Jose

    A Coruña

  • C.S. Zona Ii

    Albacete

  • C.S. Aldea Moret

    Cáceres

  • C.S. Fuencarral

    Madrid

  • C.S. Mendiguchia

    Madrid

  • Centro Urología, Andrología Y Salud Sexual

    Palma de Mallorca

  • C.S. Rotxapea

    Pamplona

  • Cs Vargas, Santander

    Santander, Cantabria

  • C.S. Soria Rural

    Soria

  • C.S. Laguna de Duero

    Valladolid

  • Cs Villamayor de Gallego

    Zaragoza

Other trials in Spain

About this study

Official title: A 6-months Prospective, Observational Study to Evaluate the Quality of Life of Patients Treated With Phytotherapy or Alpha-blockersfor Benign Prostatic Hyperplasia

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.

Read the 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.

Being tested
Phytotherapy
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhytotherapyDrug

    Also called Alpha-blockers

    Phytotherapy or alphablockers

Study groups in NCT07144709
Study groupRoleWhat they receive
PhytotherapyPatients initiating a first-line phytotherapy treatment for LUTS/BPH in monotherapy
Receives: Drug: Phytotherapy
Alpha-blockersPatients initiating a first-line alpha-blockers treatment for LUTS/BPH in monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (5)

  1. Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9), M6

    Mean difference in BPHQOL9 scores between baseline and M3 or M6, by group of treatment 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.

    Measured: 6 months

  2. Quality of life Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9)

    Quality of life changes using BPHQOL9 questionnaire over the 6-month period.

    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.

    Measured: 6 months

  3. Urinary symptoms profiles

    Urinary symptoms profiles using International Prostate Score Symptom (IPSS) questionnaire over the 6-month period by group of treatment.

    Score has a total range from 0 to 35 (sum of the first 7 questions) with 3 defined severity states (0-7 = mild; 8-19 = moderate; 20-35 = severe). A higher score means a worse urinary difficulties.

    Measured: 6 months

  4. Sexual Fonction

    Sexual function and satisfaction using Male Sexual Health Questionnaire (MSHQ) over the 6-month period by group of treatment.

    The MSHQ total score ranges from 0 to 125 (sum of all items). Higher scores indicate better sexual function.

    Measured: 6 months

  5. Safety (Adverse events)

    Safety assessment over the 6-month period by group of treatment

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start22 Jun 2022
  3. Primary completion29 Jul 2024
  4. Study completion29 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07144709
Sponsor's protocol ID
PierreFabreMed
Acronym
PERQoL
Status last verified
Aug 2025
First submitted
23 Jul 2025
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Benign Prostatic Hyperplasia, run by Pierre Fabre Medicament at 31 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9) M6 (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07144709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

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