Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia

Not Applicable

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Other: Teleconsultation; Other: Hospital (control)

• Registration Number: NCT02947958
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 299

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teleconsultation	Teleconsultation	Tele consultation (experimental) - after the randomization the patient is guided to seek primary care under teleconsultation supervision to keep his treatment. One year later the patient's symptoms are reassessed in a medical consultation.
Hospital	Hospital (control)	Hospital (control) - after the randomization the patient is guided to keep his treatment in the tertiary care as usual. One year later the patient's symptoms are reassessed in a medical consultation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change from baseline Prostatic Specific Antigen (PSA)	12 months	Prostatic specific antigen serum values will be assessed at randomization and after twelve months.
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
Adhesion to Medications	12 months	The adhesion to prescribed medications will be assessed after 12 months of the randomization

Trial Locations

Locations (1)

Hospital De Clinicas De Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil