Clinical trial NCT02947958: Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hyperplasia
Keywords: teleconsultation
urology
primary care
tertiary care
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2016-10-28
Enrollment: 299
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change from baseline Low Urinary Tract Symptoms (LUTS)
timeFrame: 12 months
Secondary outcomes:
measure: Occurrence of Acute Urinary Retention (AUR)
timeFrame: 12 months
measure: Change from baseline Serum Creatinine
timeFrame: 12 months
measure: Change from baseline Serum Urea
timeFrame: 12 months
measure: Change from baseline Prostatic Specific Antigen (PSA)
timeFrame: 12 months
measure: Occurrence of Urinary infection
timeFrame: 12 months
measure: Adhesion to Medications
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital De Clinicas De Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Brasil S Neto, MdPg
role: PRINCIPAL_INVESTIGATOR
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