Lower Urinary Tract Symptoms associated with Benign Prostatic Hyperplasia
Conditions
Interventions
No intervention. Observational.
Sponsors
European Association of Urology Research Foundation (EAU-RF)
Eligibility
Inclusion criteria
Inclusion criteria: A patient will be considered eligible for inclusion in this registry only if all of the following criteria apply: 1. Males, aged ¡Ã50 years; 2. Patients with LUTS/BPH presenting to the GP or urologist who are either: A. Presently/recently untreated with pharmacological agents for LUTS/BPH and with an IPSS ¡Ã8 starting LUTS/BPH pharmacological treatment at or directly after the baseline visit, and fulfilling one of the following criteria: a. Newly diagnosed; b. Previously managed with watchful waiting; c. Discontinued LUTS/BPH pharmacological treatment prior to the baseline visit for the following period: - Blockers or phytotherapy or anticholinergics for ¡Ã 1 month; - 5ARIs either as monotherapy or in combination for ¡Ã 6 months; - Other LUTS/BPH medical therapy for ¡Ã1 months; OR B. Presently/recently treated with pharmacological agents for LUTS/BPH prior to the baseline visit for the following period, and will continue LUTS/BPH pharmacological treatment: a. Blockers or phytotherapy or anticholinergics for ¡Ã 1 month; b. 5ARIs either as monotherapy or in combination for ¡Ã 6 months; c. Other LUTS/BPH medical therapy for ¡Ã1 months. 3. Patient has given written informed consent to take part in the registry for a period up to 2 years; 4. Patient is capable of understanding and completing the questionnaires.
Exclusion criteria
Exclusion criteria: A patient will not be eligible for inclusion in this registry if any of the following criteria apply: 1. Patients with other pathological or metabolic conditions that might explain the LUTS (e.g. bladder infection, chronic cystitis, bladder/prostate cancer, bladder stones); 2. Patients in whom the decision has been taken at baseline visit to manage them with watchful waiting or other then pharmacological LUTS/BPH therapy; 3. Patients with previous history of prostate cancer; 4. Patients who are participating, or have participated in the last 6 months, in any interventional clinical trial; 5. Patients planning to move to another part of the country or abroad which indicates that they need to discontinue participation prior to the total follow up of 2 years; 6. Patients previously treated with minimal invasive or surgical treatments for their LUTS/BPH or surgical treatments involving the bladder, prostate or urethra; 7. Patients with a history or current illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the registry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with symptom persistence (defined as IPSS ¡Ã8 points) at Month 24 in each country. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints to be evaluated in each country: 1. Proportion of patients with symptom persistence (defined as IPSS ¡Ã8 points) at baseline visit** and at Month 6*, and at Month 12, and changes from baseline visit** to Month 12 and to Month 24; 2. Proportion of patients with symptom worsening (defined as IPSS increase of ¡Ã3 points, and, separately, IPSS increase of ¡Ã4 points from baseline visit) at Month 6*, and at Month 12 and at Month 24; 3. Proportion of patients with symptom improvement (defined as IPSS reduction of ¡Ã3 points, and, separately, IPSS reduction of ¡Ã4 points from baseline visit) at Month 6*, and at Month 12 and at Month 24; 4. IPSS at baseline visit, and at Month 6*, and at Month 12, and at Month 24, and changes from baseline visit to Month 6*, and to Month 12, and to Month 24; 5. Proportion of patients waking up >3 times per night at baseline visit, and at Month 6*, and at Month 12, and at Month 24, and changes from baseline visit to Month 6*, and to Month 12, and to Month 24; 6. Proportion of patients with mild (IPSS=1-7), and moderate (IPSS=8-19), and severe (IPSS=20-35) symptoms at baseline visit¢Ó, and at Month 6*, and at Month 12, and at Month 24, and changes from baseline visit to Month 6*, and to Month 12, and to Month 24; 7. IPSS Q8 at baseline visit, and at Month 6*, and at Month 12, and at Month 24, and changes from baseline visit to Month 6*, and to Month 12, and to Month 24; 8. BPH Impact Index (BII) at baseline visit, and at Month 6*, and at Month 12, and at Month 24. | — |
Contacts
Public ContactChristien Caris
Outcome results
None listed