NCT02947958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

October 20, 2016

Last Update Submit

December 11, 2020

Conditions

Prostatic Hyperplasia

Keywords

teleconsultationurologyprimary caretertiary care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Occurrence of Acute Urinary Retention (AUR)

    12 months

  • Change from baseline Serum Creatinine

    12 months

  • Change from baseline Serum Urea

    12 months

  • Change from baseline Prostatic Specific Antigen (PSA)

    12 months

  • Occurrence of Urinary infection

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Teleconsultation

EXPERIMENTAL

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

Hospital

ACTIVE COMPARATOR

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)

Interventions

TeleconsultationOTHER

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.

Teleconsultation
Hospital (control)OTHER

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

Hospital

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital De Clinicas De Porto Alegre

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

Location

Related Publications (11)

  • 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.

    PMID: 12657354BACKGROUND

  • 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.

    PMID: 7650822BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 11074195BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 12031373BACKGROUND

  • 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.

    PMID: 22265645BACKGROUND

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

    PMID: 15195324BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Remote ConsultationHospitals

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Referral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care ManagementHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Brasil S Neto, MdPg

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 28, 2016

Study Start

September 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)