Benign Prostatic Hyperplasia
Conditions
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.
Interventions
DRUGPhytotherapy
Phytotherapy or alphablockers
Sponsors
Kappa Santé
Pierre Fabre Medicament
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation | 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 |
Countries
France, Spain
Outcome results
None listed