A 6-months Observational Study to Evaluate the Quality of Life of Patients Treated With Phytotherapy or Alpha-blockers for Benign Prostatic Hyperplasia
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Drug: Phytotherapy
- Registration Number
- NCT07144709
- Lead Sponsor
- Pierre Fabre Medicament
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 288
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Phytotherapy Phytotherapy Patients initiating a first-line phytotherapy treatment for LUTS/BPH in monotherapy
- Primary Outcome Measures
Name Time Method Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9) M6 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 Outcome Measures
Name Time Method Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9), M6 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.
Quality of life Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9) 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.Urinary symptoms profiles 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.Sexual Fonction 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.Safety (Adverse events) 6 months Safety assessment over the 6-month period by group of treatment
Trial Locations
- Locations (31)
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
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