Prostatic Hyperplasia
Conditions
Keywords
teleconsultation, urology, primary care, tertiary care
Brief summary
To evaluate the effectiveness of the use of teleconsultation in qualifying counter-reference between tertiary and primary care for patients with stable benign prostatic hyperplasia (BPH) symptoms.
Detailed description
The effectiveness of the use of teleconsultation will be evaluated by the initial international prostate symptom score (IPSS) in patients randomized to the standard monitoring (tertiary hospital) and teleconsultation monitoring (primary care) and after twelve months.
Interventions
OTHERTeleconsultation
Teleconsultation - the teleconsultation usage in chronic diseases, such as benign hyperplasia, seems to be a promising scenario. Once the patient symptoms are evaluated and diagnosed as a stable disease he is able to keep his treatment annually. In a way to do not overload de tertiary system, such monitoring could be done under a teleconsultation with a urological supervision in the primary care.
OTHERHospital (control)
The patient will keep his usual care at the tertiary care.
Sponsors
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* males, over forty years, with clinical diagnosis or imaging diagnosis of benign prostate hyperplasia (ultrasonography, computed tomography, magnetic resonance imaging) with stable low urinary tract symptoms and International Prostate Symptom Score lower or equal to 25 points followed at tertiary care clinic.
Exclusion criteria
* low urinary tract symptoms and International Prostate Symptom Score over to 25 points, inadequate clinical treatment response, surgical treatment indication, suspicion of prostate malignancy or urethra stricture or neurogenic bladder and illiterates.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Low Urinary Tract Symptoms (LUTS) | 12 months | Low urinary tract symptoms are assessed through International Prostate Score System (IPSS) which includes seven main important symptoms of benign prostate hyperplasia, validated to portuguese. Each symptom is graduated from zero to five. This score classifies the symptoms of the lower urinary tract that will be assessed at randomization and after twelve months in each arm of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Serum Creatinine | 12 months | Serum creatinine values will be assessed at randomization and after twelve months |
| Change from baseline Serum Urea | 12 months | Serum urea values will be assessed at randomization and after twelve months |
| Occurrence of Acute Urinary Retention (AUR) | 12 months | The occurrence of spontaneous obstruction of the urinary flow secondary to the benign prostatic hyperplasia. |
| Occurrence of Urinary infection | 12 months | Occurrence of urinary tract infection during the study will be assessed through urine cultures |
| Adhesion to Medications | 12 months | The adhesion to prescribed medications will be assessed after 12 months of the randomization |
| Change from baseline Prostatic Specific Antigen (PSA) | 12 months | Prostatic specific antigen serum values will be assessed at randomization and after twelve months. |
Countries
Brazil
Outcome results
None listed