Deprescribing Tamsulosin in Older Men (PERSONAL)

PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms

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 Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Tamsulosin; Drug: Placebo

Detailed Description

The investigators will instruct participants to monitor and record their daily urinary symptoms and medication side effects through Redcap surveys, accessible via smartphone. Medication adherence, global urinary satisfaction questions, and health-related quality of life will be assessed as baseline and at the end of the study.

Monitoring frequency: Participants will monitor their symptoms every day using the PERSONAL-pilot study Redcap surveys. If the investigators notice a subject has been unresponsive to daily symptom monitoring, the investigators will reach out to the subject and offer any help we can provide. The investigators first attempt will be in the form of an email, sent to the email address provided to send patients the surveys. If the investigators do not receive a response, the investigators will follow up with a phone call to offer any help or guidance. Email template and telephone script provided in other study documents of the application.

N-of-1 Trial Procedures:

Participants will start with a 1-week open label period where participants will use the PERSONAL Redcap surveys to track daily symptoms and side effects while not taking their tamsulosin or any study pills. Based on the pharmacokinetics and expected timeframe of symptomatic relief from tamsulosin (half-life=14 to 15 hours; steady state by the 5th day of daily dosing), all N-of-1 trials will have a duration of 11 weeks during which participants will complete 2 cycles consisting of a pair of 2-week treatment periods (taking tamsulosin or placebo) separated by 1 week of wash-out on placebo. The order of treatment periods within a cycle will be random (e.g. ABAB, BABA, ABBA, or BAAB) according to pre-filled bubble packs given to participants during their orientation visit.

Participants will receive a placebo during wash-out periods between treatment periods and cycles, but the participants will be unaware of the order or duration of treatment periods or cycles to prevent self-correlating symptoms to specific treatments.

The PERSONAL Redcap will present participants with a daily questionnaire, accessible via smartphone, to track their lower urinary tract symptoms and medication side effects. All participants will also be presented a global urinary symptom bother question. At the end of each week, participants will receive additional medication adherence and treatment satisfaction questionnaires administered via the PERSONAL app as well as motivational messages summarizing their progress in the trial.

Participants will view a graphical representation of their responses summarized in chronological order for the prior day, week, or month. To maximize adherence to daily questionnaires, participants will be contacted via email or phone if they have completed fewer than 4 daily questionnaires in any week during their N-of-1 trial. At the end of the study, the participants will complete an end of-study questionnaire and a 10-30 min. interview with staff member with formal qualitative research training. Then, PERSONAL staff will review N-of-1 trial results with the participant.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamsulosin 0.4 mg or 0.8 mg, Then Placebo; Participants first received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.	Drug: Tamsulosin; Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks; Other Names: Flomax; Drug: Placebo; Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks
Experimental: Placebo, Then Tamsulosin 0.4 mg or 0.8 mg; Participants first received Placebo tablet taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks. After a washout period of 1 week, the participants then received Tamsulosin 0.4 mg or 0.8 mg taken daily in 2 week treatment periods, 4 treatment periods in 12 weeks.	Drug: Tamsulosin; Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks; Other Names: Flomax; Drug: Placebo; Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Adapted International Prostate Symptom Score (IPSS)	Lower urinary tract symptoms will be measured using the adapted IPSS (recall period changed from 1 month to 24 hours). The score ranges from 0-35, with higher scores indicating more severe symptoms.	Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Side Effect Scale	It's a self-reported instrument assessing the presence and severity of common tamsulosin side effects over the past 24 hour period. Possible scores range from 0 (not at all bothered) to 3 (extremely bothered). The total score ranges from 0-36.	Daily for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS 29 v2.0	The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.	Baseline and 12-week follow-up
Revised Patients' Attitudes Towards Deprescribing (rPATD) Questionnaire	Participants were asked several questions regarding their beliefs and attitudes towards deprescribing.	Baseline and 12-week follow-up
Urinary Bother Scale	It's a self-reported instrument assessing how the participants would feel if they were to spend the rest of their life with their urinary condition as it is now for the past 24 hour period. Possible scores range from 0 (delighted) to 6 (terrible).	Baseline and 12-week follow-up
Voils Medication Adherence Questionnaire	Participants were asked several questions regarding the extent of medication nonadherence and the reasons for medication nonadherence. For the extent of medication nonadherence, 3 questions were asked. Possible scores range from 0 (strongly disagree) to 4 (strongly agree, worse outcome) per question. For the reasons of medication nonadherence, 19 questions were asked. Possible scores range from 0 (not at all) to 4 (very much, worse outcome) per question.	Baseline and 12-week follow-up
Post-Study System Usability Questionnaire	Participants were asked their perceived satisfaction with the usability of the PERSONAL app. 8 questions were asked. Possible scores range from 0 (strongly disagree) to 4 (strongly agree, better outcome) per question.	12-week follow-up
Perceived Change in Urinary Status Questionnaire	Participants were asked several questions if they felt that their urinary symptoms were unchanged, improved, or worsened	Baseline and 12-week follow-up

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Benjmain N Breyer, MD, MAS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2021
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Adrenergic Agents; Urological Agents; Adrenergic Antagonists; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: 19-28557; K12DK111028 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No