Deprescribing Tamsulosin in Older Men

NCT05415748 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 19-28557K12DK111028
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Medication Side Effect Scale

  Daily for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.

Other Outcomes (6)

• Urinary Bother Scale

  Baseline and 12-week follow-up

• PROMIS 29 v2.0

  Baseline and 12-week follow-up

• Voils Medication Adherence Questionnaire

  Baseline and 12-week follow-up

Study Arms (2)

Tamsulosin 0.4 mg or 0.8 mg, Then Placebo

EXPERIMENTAL

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; Drug: Placebo

Placebo, Then Tamsulosin 0.4 mg or 0.8 mg

EXPERIMENTAL

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; Drug: Placebo

Interventions

Tamsulosin DRUG

Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks

Also known as: Flomax

Placebo, Then Tamsulosin 0.4 mg or 0.8 mg; Tamsulosin 0.4 mg or 0.8 mg, Then Placebo

Placebo DRUG

Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks

Placebo, Then Tamsulosin 0.4 mg or 0.8 mg; Tamsulosin 0.4 mg or 0.8 mg, Then Placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr. Scott Bauer
• Organization: UCSF

scott.bauer@ucsf.edu

650-515-2879

Study Officials

• Benjmain N Breyer, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: September 18, 2021
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)