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Completed

NCT Number: NCT07144709

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

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Medical Office of Delsart MD, Bersée, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phytotherapy

Drug

Phytotherapy or alphablockers

Other names: Alpha-blockers

Primary outcomes

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

    Time frame: 6 months

    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.

Secondary outcomes

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

  3. Urinary symptoms profiles

    Time frame: 6 months

    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.

  4. Sexual Fonction

    Time frame: 6 months

    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.

  5. Safety (Adverse events)

    Time frame: 6 months

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

Other outcomes

  1. Correlation

    Time frame: 6 months

    BPHQOL9 total score and IPSS QoL score will be estimated per patient at each time measurement (baseline, M3 and M6) in order to assess corelations between both scores

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Collaborators

  • Kappa Santé

Registry information

Official study title

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

Acronym: PERQoL

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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