An observational study to evaluate the quality of life of patients treated with phytotherapy or alpha-blockers for benign prostatic hyperplasia (PERQOL).
An observational study to evaluate the quality of life of patients treated with phytotherapy or alpha-blockers for benign prostatic hyperplasia (PERQOL).
A 6-months prospective, observational study to evaluate the quality of life of patients treated with phytotherapy or alpha-blockers for benign prostatic hyperplasia.
How is the study conducted?
This is a prospective, observational study, conducted in France and Spain. Any patient with moderate to severe LUTS/BPH initiating treatment with
phytotherapy or alpha-blockers will be invited to participate. Each site will enroll the same number of patients starting phytotherapy and starting alpha-blockers. Overall, 314 patients should be included in the study. Visits will be scheduled as per routine practice. Study questionnaires will be completed by patients at study entry, after 3 months, and 6 months of treatment.
No specific medical procedures or in-person clinical visits beyond routine care will be required for this study.
Who can take part in the trial ?
To be part of the study, patient must fulfill several conditions including the following:
• Male patient, age ≥ 40 years at the time of enrollment.
• Patient diagnosed with moderate to severe LUTS/BPH.
• Patient initiating a first-line phytotherapy or alpha-blockers treatment for LUTS/BPH in monotherapy.
• Provided informed consent or non-opposition to study inclusion (only for Spain).
• Patient who did not undergo prostate surgery or urinary tract surgery.
• Patient not diagnosed with one or several other diseases involving urinary function or prostate.
• Patient not 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).
• Not participating in interventional trial on any investigation drug at time of inclusion
• Not under treatment of the urinary functions
What are the objectives of the trial and how are they evaluated ?
The primary objective of PERQOL is to describe the change in QoL of patients receiving treatment for LUTS/BPH (phytotherapy or alpha-blockers) between the beginning of the study and the 6 months of use through a questionnaire.
The secondary objectives of PERQOL are to:
• Describe demographic and clinical characteristics of patients receiving treatment for LUTS/BPH by collecting data such as age, comorbidities, concomitant treatments, initial treatment(s) for LUTS/BPH...
• Describe urinary symptoms of patients receiving treatment for LUTS/BPH.
• Describe sexual function and satisfaction of patients receiving treatment for LUTS/BPH.
• Describe side effects of LUTS/BPH treatments.