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

Pierre Fabre Medicament288 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

288

Conditions

Benign Prostatic Hyperplasia

Interventions

PhytotherapyDRUG

Phytotherapy or alphablockers

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (31)

Medical Office of Delsart MD

Bersée, France

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

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.

Time frame: 6 months

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.

Time frame: 6 months

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.

Time frame: 6 months

Safety (Adverse events)

Data from ClinicalTrials.gov

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