Last updated: 11/21/2025 15:40:28

An analysis on the management trends in Benign Prostatic Hyperplasia (BPH) patients at risk of progression

GSK study ID
219074
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: BPH: MIRROR - Management trends in BPH patients at risk of progression: a real-world practice analysis
Trial description: This study will analyze the real-world clinical management of BPH patients treated with 5 alpha-reductase inhibitors (5ARIs) from perspective of physicians only. It will also focus on the physician's understanding of risk of progression, drivers of treatment decision and process of Prostate Specific Antigen (PSA) monitoring in patients treated with 5ARIs by physicians.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of patients for whom predefined clinical and demographic parameters were used to assess risk of progression

Timeframe: Up to 6 months

Secondary outcomes:

Number of participants adherent to clinical guidelines while treating BPH patients with 5ARIs

Timeframe: Up to 6 months

Number of participants with frequency of testing of parameters to monitor BPH progression

Timeframe: Up to 6 months

Number of participants who reported barriers faced in initiating 5ARI treatment

Timeframe: Up to 6 months

Importance of symptom relief versus (vs) risk of progression when deciding on BPH treatment

Timeframe: Up to 6 months

Number of participants reporting most concerning long term clinical outcomes of BPH progression

Timeframe: Up to 6 months

Number of participants using guidelines in stratifying risk of progression of BPH patients in clinical practice

Timeframe: Up to 6 months

Correlation between risk of progression and treatment with 5ARI

Timeframe: Up to 6 months

Number of patients with whom participants discuss pharmacological treatment options prior to initiation

Timeframe: Up to 6 months

Number of participants who reported frequency of types of PSA monitoring in BPH patients treated with 5ARIs

Timeframe: Up to 6 months

Number of participants who reported triggers for prostate biopsy in case of Prostate Cancer (PCa)

Timeframe: Up to 6 months

Number of participants who reported benefits of using 5ARIs in long term management of BPH

Timeframe: Up to 6 months

Number of participants who reported concerns of using 5ARIs in long term management of BPH

Timeframe: Up to 6 months

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-14-04
Observational study model:
Cohort
Time perspective:
Cross-Sectional
Clinical publications:
Palacios-Moreno J, Kapse P, Cortes V, Averbeck M, Alba A, Souza D, et al. . Management of Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Enlargement at Risk of Progression Treated with 5-Alpha-Reductase Inhibitors: Examining Real-World Clinical Practice in Spain and Brazil. BMC Urol. 2025-11-17;25(1) doi:10.1186/s12894-025-01966-6 https://doi.org/10.1186/s12894-025-01966-6 PMID: 41250066 DOI: 10.1186/s12894-025-01966-6
Medical condition
Prostatic Hyperplasia
Product
tamsulosin
Collaborators
Not applicable
Study date(s)
February 2023 to April 2023
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Male
Age
Not applicable+ years
Accepts healthy volunteers
No
  • Participants should be practicing as Urologists
  • Participants should have between 5 to 35 years of practice experience
  • Participants have not treated at least 10 BPH patients per month on average in the last 12 months
  • Participant who reports any reasons they cannot complete the study
Inclusion and exclusion criteria
Inclusion criteria:
  • Participants should be practicing as Urologists
  • Participants should have between 5 to 35 years of practice experience
  • Participants should spend at least 60 percent (%) of their time in direct patients care
  • Participants should have personally seen, and managed at least 10 different BPH patients in the last one month
  • Participants should be able to fill out at least two patient record forms for patients aged 50 years or older, diagnosed with BPH (anytime) and initiated on 5-ARIs treatment by them in the last one year (in monotherapy or combination with alpha blockers)
  • Participants must be able to give informed consent
Exclusion criteria:
  • Participants have not treated at least 10 BPH patients per month on average in the last 12 months
  • Participant who reports any reasons they cannot complete the study

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2023-14-04
Actual study completion date
2023-14-04

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website