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

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ClinicalTrials.gov Identifier: NCT02947958
Recruitment Status : Unknown
Verified October 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : October 28, 2016
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Other: Teleconsultation Other: Hospital (control) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 284 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947958


Contacts
Contact: Brasil S. Neto, MdPg 555133598286 bneto@hcpa.edu.br

Locations
Brazil
Hospital De Clinicas De Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Contact: Brasil S Neto, MdPg    555133598286    bneto@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: Brasil S Neto, MdPg Hospital de Clinicas de Porto Alegre

Additional Information:
Publications:
Ferreira, J. B. B. et al. O complexo regulador da assistência à saúde na perspectiva de seus sujeitos operadores. Interface (Botucatu), Botucatu, v. 14, n. 33, June 2010
Fratini, J. G.; Sauoe, R.; Massaroli, A. Referência e contra referência: contribuição para a integralidade em saúde. Cienc Cuid Saude, Itajaí, v. 7, n. 1, p. 65-72, Jan/Mar 2008
Gusso, G.; Lopes, J. M. C. Tratado de Medicina de Família e Comunidade - 2 Volumes: Princípios, Formação e Prática. Artmed, 1ed., Porto Alegre, 2012
Mattos, L. A. P. et al. Desfechos clínicos aos 30 dias do registro brasileiro das síndromes coronárias agudas (ACCEPT). Arq. Bras. Cardiol., São Paulo, v.100, n. 1, Jan. 2013
Berger, Milton ; LUZ JR, Pedro Nery da ; SILVA NETO, Brasil ; KOFF, Walter José . Validação estatística do escore internacional de sintomas prostáticos (IPSS) na língua portuguesa. Jornal Brasileiro de Urologia, Rio de Janeiro/RJ, v. 25, n. 2, p. 225-234, 1999.

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02947958     History of Changes
Other Study ID Numbers: 28976614000005327
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
teleconsultation
urology
primary care
tertiary care

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male