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

Primary Purpose

Prostatic Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Teleconsultation

Hospital (control)

About this trial

This is an interventional other trial for Prostatic Hyperplasia focused on measuring teleconsultation, urology, primary care, tertiary care

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Hospital De Clinicas De Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teleconsultation

Hospital

Arm Description

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 (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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Occurrence of Acute Urinary Retention (AUR)

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

Change from baseline Serum Creatinine

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

Change from baseline Serum Urea

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

Change from baseline Prostatic Specific Antigen (PSA)

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

Occurrence of Urinary infection

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

Adhesion to Medications

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

Full Information

NCT ID

NCT02947958

First Posted

October 20, 2016

Last Updated

December 11, 2020

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul

1. Study Identification

Unique Protocol Identification Number

NCT02947958

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

September 2014 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Hyperplasia

Keywords

teleconsultation, urology, primary care, tertiary care

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

299 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teleconsultation

Arm Type

Experimental

Arm Description

Arm Title

Hospital

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Teleconsultation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Hospital (control)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline Low Urinary Tract Symptoms (LUTS)

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Occurrence of Acute Urinary Retention (AUR)

Description

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

Time Frame

12 months

Title

Change from baseline Serum Creatinine

Description

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

Time Frame

12 months

Title

Change from baseline Serum Urea

Description

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

Time Frame

12 months

Title

Change from baseline Prostatic Specific Antigen (PSA)

Description

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

Time Frame

12 months

Title

Occurrence of Urinary infection

Description

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

Time Frame

12 months

Title

Adhesion to Medications

Description

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

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brasil S Neto, MdPg

Organizational Affiliation

Hospital de Clinicas de Porto Alegre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital De Clinicas De Porto Alegre

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12657354

Citation

Carson C 3rd, Rittmaster R. The role of dihydrotestosterone in benign prostatic hyperplasia. Urology. 2003 Apr;61(4 Suppl 1):2-7. doi: 10.1016/s0090-4295(03)00045-1.

Results Reference

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PubMed Identifier

7650822

Citation

Davis DA, Thomson MA, Oxman AD, Haynes RB. Changing physician performance. A systematic review of the effect of continuing medical education strategies. JAMA. 1995 Sep 6;274(9):700-5. doi: 10.1001/jama.274.9.700.

Results Reference

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Citation

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

Results Reference

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Citation

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

Results Reference

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Citation

Gusso, G.; Lopes, J. M. C. Tratado de Medicina de Família e Comunidade - 2 Volumes: Princípios, Formação e Prática. Artmed, 1ed., Porto Alegre, 2012

Results Reference

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PubMed Identifier

11074195

Citation

Kirby RS. The natural history of benign prostatic hyperplasia: what have we learned in the last decade? Urology. 2000 Nov 1;56(5 Suppl 1):3-6. doi: 10.1016/s0090-4295(00)00747-0.

Results Reference

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Citation

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

Results Reference

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PubMed Identifier

12031373

Citation

Platz EA, Smit E, Curhan GC, Nyberg LM, Giovannucci E. Prevalence of and racial/ethnic variation in lower urinary tract symptoms and noncancer prostate surgery in U.S. men. Urology. 2002 Jun;59(6):877-83. doi: 10.1016/s0090-4295(01)01673-9. Erratum In: Urology. 2003 May;61(5):1078.

Results Reference

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PubMed Identifier

22265645

Citation

Starfield B. Primary care: an increasingly important contributor to effectiveness, equity, and efficiency of health services. SESPAS report 2012. Gac Sanit. 2012 Mar;26 Suppl 1:20-6. doi: 10.1016/j.gaceta.2011.10.009. Epub 2012 Jan 21.

Results Reference

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PubMed Identifier

15195324

Citation

Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.

Results Reference

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Citation

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.

Results Reference

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Links:

URL

http://bvsms.saude.gov.br/bvs/saudelegis/gm/2011/prt2546_27_10_2011.html

Description

Portaria Ministério Da Saúde

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

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