CompletedPhase 4

Deprescribing Tamsulosin in Older Men

United States31 participantsStarted 2021-09-18

Plain-language 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.

Who can participate

Age range

55 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \<12 months. * International Prostate Symptom Score \<5 or \>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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Adapted International Prostate Symptom Score (IPSS)

Timeframe: Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.

Trial details

NCT IDNCT05415748

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-22

Results submitted2024-12-12

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials