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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947958
• Other study ID #: 28976614000005327
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: December 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.
• Hospital (control)
The patient will keep his usual care at the tertiary care.

Locations

Country	Name	City	State
Brazil	Hospital De Clinicas De Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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.

Carson C 3rd, Rittmaster R. The role of dihydrotestosterone in benign prostatic hyperplasia. Urology. 2003 Apr;61(4 Suppl 1):2-7. — View 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. — View 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

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

Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. Review. — View 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. Review. — View 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

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. Erratum in: Urology. 2003 May;61(5):1078. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of Acute Urinary Retention (AUR)	The occurrence of spontaneous obstruction of the urinary flow secondary to the benign prostatic hyperplasia.	12 months
Secondary	Change from baseline Serum Creatinine	Serum creatinine values will be assessed at randomization and after twelve months	12 months
Secondary	Change from baseline Serum Urea	Serum urea values will be assessed at randomization and after twelve months	12 months
Secondary	Change from baseline Prostatic Specific Antigen (PSA)	Prostatic specific antigen serum values will be assessed at randomization and after twelve months.	12 months
Secondary	Occurrence of Urinary infection	Occurrence of urinary tract infection during the study will be assessed through urine cultures	12 months
Secondary	Adhesion to Medications	The adhesion to prescribed medications will be assessed after 12 months of the randomization	12 months

External Links

•   Portaria Ministério Da Saúde