Benign Prostatic HyperplasiaPhase 4PERSONALNCT05415748
Deprescribing Tamsulosin in Older Men
A Phase 4 study testing Tamsulosin in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2021to 22 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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.
- Being tested
- Tamsulosin, Placebo
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Flomax
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tamsulosin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.
Secondary outcomes (1)
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.
Measured: Daily for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start18 Sep 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjmain N Breyer, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415748
- Sponsor's protocol ID
- 19-28557
- Other IDs
- K12DK111028
- Acronym
- PERSONAL
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2022
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bauer SR, Kenfield SA, Oni-Orisan A, Shlipak MG, Lu K, Rios N, Pearce R, Harmon J, McCulloch CE, Huang L, Steinman MA, Breyer BN. Tamsulosin Deprescribing for Lower Urinary Tract Symptoms in Older Men: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2621639. doi: 10.1001/jamanetworkopen.2026.21639.
PubMed 42406401
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PlacEbo-controlled, Randomized, Patient-Selected Outcomes N-of-1 triALs (PERSONAL-pilot): Alpha-blockers for Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT05415748
- Acronym / sponsor ID
- PERSONAL / 19-28557
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Sep 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin 0.4 mg or 0.8 mg, Then Placebo | Experimental | Drug: Tamsulosin, Drug: PlaceboParticipants 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. |
| Placebo, Then Tamsulosin 0.4 mg or 0.8 mg | Experimental | Drug: Tamsulosin, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinAlso: FlomaxTamsulosin and matching placebo to be taken in a randomized order for 12 weeks | Drug | Placebo, Then Tamsulosin 0.4 mg or 0.8 mg, Tamsulosin 0.4 mg or 0.8 mg, Then Placebo |
| PlaceboTamsulosin and matching placebo to be taken in a randomized order for 12 weeks | Drug | Placebo, Then Tamsulosin 0.4 mg or 0.8 mg, Tamsulosin 0.4 mg or 0.8 mg, Then Placebo |
Primary outcome
Change in Adapted International Prostate Symptom Score (IPSS)
Time frame: Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.
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.
1 secondary outcome
Medication Side Effect Scale
Time frame: Daily for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42406401Bauer SR, Kenfield SA, Oni-Orisan A, Shlipak MG, Lu K, Rios N, Pearce R, Harmon J, McCulloch CE, Huang L, Steinman MA, Breyer BN. Tamsulosin Deprescribing for Lower Urinary Tract Symptoms in Older Men: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2621639. doi: 10.1001/jamanetworkopen.2026.21639.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjmain N Breyer, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adapted International Prostate Symptom Score (IPSS) (time frame: Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.