Evaluation of the Effectiveness of the Use of Teleconsultation in Qualifying Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia: Randomized Clinical Trial of Noninferiority
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostatic Hyperplasia
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 299
- Locations
- 1
- Primary Endpoint
- Change from baseline Low Urinary Tract Symptoms (LUTS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from baseline Low Urinary Tract Symptoms (LUTS)
Time Frame: 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 Outcomes
- Occurrence of Acute Urinary Retention (AUR)(12 months)
- Occurrence of Urinary infection(12 months)
- Change from baseline Prostatic Specific Antigen (PSA)(12 months)
- Change from baseline Serum Creatinine(12 months)
- Change from baseline Serum Urea(12 months)
- Adhesion to Medications(12 months)