Last updated: 11/03/2018 19:08:47
Prospective cohort study for patients’ adherence on lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) pharmacological treatment in real practice
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Prospective cohort study for patients’ adherence on lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) pharmacological treatment in real practice
Trial description: Prospective and 1-year follow-up study
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Adherence rate on BPH pharmacological treatment
Timeframe: 1 year
Secondary outcomes:
Average and median period until patients stop visiting the investigator
Timeframe: 1 year
Fraction of patient who received α-blocker or 5-ARI according to IPSS severity at first viit(baseline).
Timeframe: NA
The reasons why patients stop BPH pharmacologic treatment
Timeframe: 1 year
IPSS, prostate volume, PSA and Qmax at the beginning of treatment
Timeframe: NA
Fraction of patient who received α-blocker or 5-ARI according to a size of prostate at first visit(baseline).
Timeframe: NA
Interventions:
Not applicable
Enrollment:
1009
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Benign Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
December 2012 to August 2015
Type
Observational
Phase
4
Participation criteria
Sex
Male
Age
Not applicable
Accepts healthy volunteers
none
- BPH patients with LUTS
- Subjects who received prescription for BPH treatment
- Subjects who got treatment for BPH in past 6 months
- Subjects who had LUTS without BPH
Inclusion and exclusion criteria
Inclusion criteria:
- BPH patients with LUTS
- Subjects who received prescription for BPH treatment
- Subjects who signed informed consent
Exclusion criteria:
- Subjects who got treatment for BPH in past 6 months
- Subjects who had LUTS without BPH
- Subjects who were planned to get surgical treatment for BPH
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
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
Not applicable
Actual study completion date
2015-20-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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