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

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Completed

CT.gov ID

NCT02947958

Collaborator

Federal University of Rio Grande do Sul (Other)

299

Enrollment

Location

Arms

Actual Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Other: Teleconsultation Other: Hospital (control)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

299 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Teleconsultation 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.
Active Comparator: Hospital 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) The patient will keep his usual care at the tertiary care.

Arm

Intervention/Treatment

Experimental: 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.

Other: Teleconsultation

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.

Active Comparator: Hospital

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)

The patient will keep his usual care at the tertiary care.

Outcome Measures

Primary Outcome Measures

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

Occurrence of Acute Urinary Retention (AUR) [12 months]
The occurrence of spontaneous obstruction of the urinary flow secondary to the benign prostatic hyperplasia.
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
Change from baseline Prostatic Specific Antigen (PSA) [12 months]
Prostatic specific antigen serum values will be assessed at randomization and after twelve months.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.