Prostatic HyperplasiaNCT02947958
Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia
A study testing Teleconsultation in people with Prostatic Hyperplasia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital De Clinicas De Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
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
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.
Read the 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.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Teleconsultation, Hospital (control)
- Keywords
- teleconsultation, urology, primary care, tertiary care
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Hospital (control)Other
The patient will keep his usual care at the tertiary care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Hospital (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Occurrence of Acute Urinary Retention (AUR)
The occurrence of spontaneous obstruction of the urinary flow secondary to the benign prostatic hyperplasia.
Measured: 12 months
Change from baseline Serum Creatinine
Serum creatinine values will be assessed at randomization and after twelve months
Measured: 12 months
Change from baseline Serum Urea
Serum urea values will be assessed at randomization and after twelve months
Measured: 12 months
Change from baseline Prostatic Specific Antigen (PSA)
Prostatic specific antigen serum values will be assessed at randomization and after twelve months.
Measured: 12 months
Occurrence of Urinary infection
Occurrence of urinary tract infection during the study will be assessed through urine cultures
Measured: 12 months
Adhesion to Medications
The adhesion to prescribed medications will be assessed after 12 months of the randomization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startSep 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Brasil S Neto, MdPg, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947958
- Sponsor's protocol ID
- 28976614000005327
- Status last verified
- Dec 2020
- First submitted
- 20 Oct 2016
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12657354Davis 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.
PubMed 7650822Ferreira, 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
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.
PubMed 11074195Mattos, 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. doi: 10.1016/s0090-4295(01)01673-9.
PubMed 12031373Starfield 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.
PubMed 22265645Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
PubMed 15195324Berger, 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02947958
- Acronym / sponsor ID
- 28976614000005327
- Conditions
- Prostatic Hyperplasia
- Keywords
- teleconsultation, urology, primary care, tertiary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Sep 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation | Experimental | Other: TeleconsultationTele 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 | Active comparator | Other: Hospital (control)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleconsultationTeleconsultation - 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. | Other | Teleconsultation |
| Hospital (control)The patient will keep his usual care at the tertiary care. | Other | Hospital |
Primary outcome
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.
6 secondary outcomes
Occurrence of Acute Urinary Retention (AUR)
Time frame: 12 months
Change from baseline Serum Creatinine
Time frame: 12 months
Change from baseline Serum Urea
Time frame: 12 months
Change from baseline Prostatic Specific Antigen (PSA)
Time frame: 12 months
Occurrence of Urinary infection
Time frame: 12 months
Adhesion to Medications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Background: PubMed 12657354Carson 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.
- Background: PubMed 7650822Davis 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.
- BackgroundFerreira, 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
- BackgroundFratini, 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
- BackgroundGusso, G.; Lopes, J. M. C. Tratado de Medicina de Família e Comunidade - 2 Volumes: Princípios, Formação e Prática. Artmed, 1ed., Porto Alegre, 2012
- Background: PubMed 11074195Kirby 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.
- BackgroundMattos, 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: PubMed 12031373Platz 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.
- Background: PubMed 22265645Starfield 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.
- Background: PubMed 15195324Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.
- BackgroundBerger, 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.
- Portaria Ministério Da SaúdeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Prostatic Hyperplasia
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brasil S Neto, MdPg principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation in people with Prostatic Hyperplasia, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Low Urinary Tract Symptoms (LUTS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947958, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.