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| ID | Type | Description | Link |
|---|---|---|---|
| K12DK111028 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks |
|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| PROMIS 29 v2.0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjmain N Breyer, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42406401 | Derived | 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. |
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This is their original dosage of either 0.4 or 0.8 mg of tamsulosin and we are showing in the results on the drug or off the drug periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Tamsulosin, Placebo Then Tamsulosin | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period, followed by a one week placebo washout, participants then received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period. |
| FG001 | Placebo Then Tamsulosin, Tamsulosin Then Placebo | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period, followed by a one week placebo washout, participants then received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period. |
| FG002 | Tamsulosin Then Placebo, Tamsulosin Then Placebo | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period, followed by a one week placebo washout, participants then received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period |
| FG003 | Tamsulosin Then Placebo, Placebo Then Tamsulosin | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period, followed by a one week placebo washout, participants then received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wash-out #1 (1 Week) |
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| Intervention #1 (2 Weeks) |
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| Wash-out #2 (1 Week) |
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| Intervention #2 (2 Weeks) |
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| Wash-out #3 (1 Week) |
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| Intervention #3 (2 Weeks) |
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| Wash-out #4 (1 Week) |
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| Intervention #4 (2 Weeks) |
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This is their original dosage of either 0.4 or 0.8 mg of tamsulosin and we are showing in the results on the drug or off the drug periods.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Tamsulosin, Placebo Then Tamsulosin | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period, followed by a one week placebo washout, participants then received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | A direct comparison between the 0.4 mg and 0.8 mg dose groups was not pre-specified in the study design and was therefore not conducted. | Posted | Mean | Standard Deviation | score on a scale | Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period. |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/Tamsulosin | Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Bauer | UCSF | 650-515-2879 | scott.bauer@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2024 | Dec 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2023 | Dec 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Tamsulosin and matching placebo to be taken in a randomized order for 12 weeks |
|
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 |
| 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 |
| 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 |
| 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 |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| COMPLETED |
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| BG001 | Placebo Then Tamsulosin, Tamsulosin Then Placebo | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period, followed by a one week placebo washout, participants then received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period. |
| BG002 | Tamsulosin Then Placebo, Tamsulosin Then Placebo | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period, followed by a one week placebo washout, participants then received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period |
| BG003 | Tamsulosin Then Placebo, Placebo Then Tamsulosin | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period, followed by a one week placebo washout, participants then received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo Then Tamsulosin, Tamsulosin Then Placebo | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period, followed by a one week placebo washout, participants then received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period. |
| OG002 | Tamsulosin Then Placebo, Tamsulosin Then Placebo | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period, followed by a one week placebo washout, participants then received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period |
| OG003 | Tamsulosin Then Placebo, Placebo Then Tamsulosin | Tamsulosin and matching placebo to be taken in a randomized quarter for 12 weeks after a one-week placebo run-in. After the one week placebo run-in, participants first received tamsulosin 0.4 mg or 0.8 mg taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by placebo taken daily for a two week treatment period, followed by a one week placebo washout, participants then received placebo taken daily for a 2 week treatment period, followed by a one week placebo washout, followed by tamsulosin 0.4 mg or 0.8 mg taken daily for a two week treatment period. |
|
|
| Secondary | 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. | A direct comparison between the 0.4 mg and 0.8 mg dose groups was not pre-specified in the study design and was therefore not conducted | Posted | Mean | Standard Deviation | score on a scale | Daily for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period. |
|
|
|
| Other Pre-specified | 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). | Not Posted | Baseline and 12-week follow-up | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline and 12-week follow-up | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline and 12-week follow-up | Participants |
| Other Pre-specified | 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. | Not Posted | 12-week follow-up | Participants |
| Other Pre-specified | Revised Patients' Attitudes Towards Deprescribing (rPATD) Questionnaire | Participants were asked several questions regarding their beliefs and attitudes towards deprescribing. | Not Posted | Baseline and 12-week follow-up | Participants |
| Other Pre-specified | Perceived Change in Urinary Status Questionnaire | Participants were asked several questions if they felt that their urinary symptoms were unchanged, improved, or worsened | Not Posted | Baseline and 12-week follow-up | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| D052801 |
| Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| Placebo |
|