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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Other: Teleconsultation
* Other: Hospital (control)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teleconsultation<br>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. | Other: Teleconsultation<br>* 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.<br>|
| Active Comparator: Hospital<br>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. | Other: Hospital (control)<br>* The patient will keep his usual care at the tertiary care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Low Urinary Tract Symptoms (LUTS) | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Acute Urinary Retention (AUR) | The occurrence of spontaneous obstruction of the urinary flow secondary to the benign prostatic hyperplasia. | 12 months | 
| Change from baseline Serum Creatinine | Serum creatinine values will be assessed at randomization and after twelve months | 12 months | 
| Change from baseline Serum Urea | Serum urea values will be assessed at randomization and after twelve months | 12 months | 
| Change from baseline Prostatic Specific Antigen (PSA) | Prostatic specific antigen serum values will be assessed at randomization and after twelve months. | 12 months | 
| Occurrence of Urinary infection | Occurrence of urinary tract infection during the study will be assessed through urine cultures | 12 months | 
| Adhesion to Medications | The adhesion to prescribed medications will be assessed after 12 months of the randomization | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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teleconsultation, urology, primary care, tertiary care