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NCT Number: NCT02947958

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

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital De Clinicas De Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teleconsultation

Other

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.

Hospital (control)

Other

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

Primary outcomes

  1. 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

  1. Occurrence of Acute Urinary Retention (AUR)

    Time frame: 12 months

    The occurrence of spontaneous obstruction of the urinary flow secondary to the benign prostatic hyperplasia.

  2. Change from baseline Serum Creatinine

    Time frame: 12 months

    Serum creatinine values will be assessed at randomization and after twelve months

  3. Change from baseline Serum Urea

    Time frame: 12 months

    Serum urea values will be assessed at randomization and after twelve months

  4. Change from baseline Prostatic Specific Antigen (PSA)

    Time frame: 12 months

    Prostatic specific antigen serum values will be assessed at randomization and after twelve months.

  5. Occurrence of Urinary infection

    Time frame: 12 months

    Occurrence of urinary tract infection during the study will be assessed through urine cultures

  6. Adhesion to Medications

    Time frame: 12 months

    The adhesion to prescribed medications will be assessed after 12 months of the randomization

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2016
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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