At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 31 enrolled
Drug / intervention
Tamsulosin +1 moredrug
Likely dose
Tamsulosin dosing per standard use; matching placebo for 12 weeks in randomized orderAI-extracted
Key inclusion· 7
- ✓Male, age 55-80 years at screening
- ✓Currently taking tamsulosin for urinary symptoms for ≥12 months
- ✓International Prostate Symptom Score 5-25
- ✓Owns Android or iPhone smartphone, tablet, or computer with home WiFi access
Key exclusion· 5
- ✕Taking tamsulosin for less than 12 months
- ✕IPSS <5 or >25
- ✕Currently enrolled in another mobile app-based clinical study
- ✕Planning to relocate during study duration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms
In Brief
A Phase 4 clinical trial evaluating Tamsulosin and Placebo for Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms. Completed, enrolled 31 participants across 1 site.
Detailed Summary
This is a pilot 12-week randomized, placebo-controlled N-of-1 deprescribing trial among older men receiving chronic tamsulosin therapy for lower urinary tract symptoms attributed to benign prostatic hyperplasia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Timeline
Phase 4CompletedFinished
20222023202420252026
Enrollment StartSep 2021
First PostedJun 2022
Primary CompletionJul 2022
TodayJul 2026
First PostedJun 13, 2022
Enrollment StartSep 18, 2021
Primary CompletionJul 22, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.1 years ago
Interventions
Tamsulosindrug
Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks
Placebodrug
Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks