Phase 4
N=31
Deprescribing Tamsulosin in Older Men
Benign Prostatic Hyperplasia · Lower Urinary Tract Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT05415748 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Adapted International Prostate Symptom Score (IPSS) — 13.5; 12.1; 14.1; 9.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tamsulosin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Male
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Adapted International Prostate Symptom Score (IPSS) |
13.5; 12.1; 14.1; 9.2; 18.7; 14.3 | — |
| SECONDARY Medication Side Effect Scale |
0.94; 2.59; 1.43; 1.15; 1.27; 2.58 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Urology patient at UCSF
- Must own Android or iPhone smartphone, tablet, or computer
- Taking tamsulosin for urinary-related symptoms
- Able to speak and read English
- Male 55-80 years old of age at telephone screening.
- Written informed consent (and assent when applicable) obtained from subject or subject' s legal representative and ability for subject to comply with the requirements of the study.
- Willing to receive electronic PERSONAL daily intake surveys for 3 months
- Willing to self-report urinary symptom or medication side effect data at specified frequency.
- Have home WiFi access.
- Patients with h/o prostate cancer may be enrolled but is not required
- Patients with h/o kidney stones may be enrolled but is not required
Exclusion Criteria
- Taking tamsulosin for 25
- Current participation in any other mobile app-based clinical study.
- Planning to relocate from area within the study duration.
- Impaired vision that could limit the use of the mobile apps (participant-reported)
Data sourced from ClinicalTrials.gov (NCT05415748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.