Last updated: 06/11/2025 14:02:02
Benign Prostatic Hyperplasia (BPH) Outcomes study – International Prostate Symptoms Score (IPSS) sub score & BPH Impact Index (BII) analysis
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Treatment Response in Profiles of Men with Prostatic Enlargement at Risk of Progression: Impact on Individual Questions of the IPSS and total BII Questionnaires as predicted outcomes – GSK sponsored study
Trial description: This study aims to expand the predictive analytic solution by including the predictive models for outcomes based IPSS sub-scores for storage and voiding and IPSS individual questions for Nocturia, as well as IPSS individual question for quality of life (QoL) along with BPH Impact Index (BII) overall questionnaire on QoL (4 questions).
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from Baseline in IPSS voiding Sub-score
Timeframe: Baseline and up to 48 months
Change from Baseline in IPSS storage Sub-score
Timeframe: Baseline and up to 48 months
Change from Baseline in Nocturia Question 7 (Q7)
Timeframe: Baseline and up to 48 months
Change from Baseline in IPSS Q8
Timeframe: Baseline and up to 48 months
Change from Baseline in Overall BII
Timeframe: Baseline and up to 48 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2023-15-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Stavros Gravas, Juan Manuel-Palacios, Chandrashekhar Chavan, Claus G Roehrborn, Matthias Oelke, Marcio Augusto Averbeck, Arunangshu Biswas, Llenalia María García, Khadeeja Mohamed, Vanessa Cortes. Modeling study of the effect of placebo and medical therapy on storage and voiding symptoms, nocturia, and quality of life in men with prostate enlargement at risk for progression. Prostate cancer and prostatic diseases. 2023-Oct-04;
DOI : 10.1038/s41391-023-00731-w
PMID : 37794168
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
November 2022 to April 2023
Type
Observational
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
No
- The inclusion criteria are determined by the studies considered for the analysis, ARI40005, ARIA3001 ARIA3002 and ARIB3003.
- The exclusion criteria are determined by the studies considered for the analysis, ARI40005, ARIA3001 ARIA3002 and ARIB3003.
Inclusion and exclusion criteria
Inclusion criteria:
- The inclusion criteria are determined by the studies considered for the analysis, ARI40005, ARIA3001 ARIA3002 and ARIB3003.
Exclusion criteria:
- The exclusion criteria are determined by the studies considered for the analysis, ARI40005, ARIA3001 ARIA3002 and ARIB3003.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
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
2023-15-04
Actual study completion date
2023-15-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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