Trial Outcomes & Findings for Deprescribing Tamsulosin in Older Men (NCT NCT05415748)
NCT ID: NCT05415748
Last Updated: 2025-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.
Results posted on
2025-08-22
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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
|
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.
|
|---|---|---|---|---|
|
Wash-out #1 (1 Week)
STARTED
|
7
|
8
|
8
|
8
|
|
Wash-out #1 (1 Week)
COMPLETED
|
6
|
7
|
6
|
8
|
|
Wash-out #1 (1 Week)
NOT COMPLETED
|
1
|
1
|
2
|
0
|
|
Intervention #1 (2 Weeks)
STARTED
|
6
|
7
|
6
|
8
|
|
Intervention #1 (2 Weeks)
COMPLETED
|
6
|
7
|
6
|
8
|
|
Intervention #1 (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Wash-out #2 (1 Week)
STARTED
|
6
|
7
|
6
|
8
|
|
Wash-out #2 (1 Week)
COMPLETED
|
6
|
7
|
6
|
8
|
|
Wash-out #2 (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention #2 (2 Weeks)
STARTED
|
6
|
7
|
6
|
8
|
|
Intervention #2 (2 Weeks)
COMPLETED
|
5
|
7
|
6
|
8
|
|
Intervention #2 (2 Weeks)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Wash-out #3 (1 Week)
STARTED
|
5
|
7
|
6
|
8
|
|
Wash-out #3 (1 Week)
COMPLETED
|
5
|
7
|
6
|
8
|
|
Wash-out #3 (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention #3 (2 Weeks)
STARTED
|
5
|
7
|
6
|
8
|
|
Intervention #3 (2 Weeks)
COMPLETED
|
5
|
7
|
6
|
8
|
|
Intervention #3 (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Wash-out #4 (1 Week)
STARTED
|
5
|
7
|
6
|
8
|
|
Wash-out #4 (1 Week)
COMPLETED
|
5
|
7
|
6
|
8
|
|
Wash-out #4 (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention #4 (2 Weeks)
STARTED
|
5
|
7
|
6
|
8
|
|
Intervention #4 (2 Weeks)
COMPLETED
|
5
|
7
|
6
|
8
|
|
Intervention #4 (2 Weeks)
NOT COMPLETED
|
0
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0
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0
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0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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
|
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.
|
|---|---|---|---|---|
|
Wash-out #1 (1 Week)
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
|
Intervention #2 (2 Weeks)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Deprescribing Tamsulosin in Older Men
Baseline characteristics by cohort
| Measure |
Placebo Then Tamsulosin, Placebo Then Tamsulosin
n=7 Participants
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.
|
Placebo Then Tamsulosin, Tamsulosin Then Placebo
n=8 Participants
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.
|
Tamsulosin Then Placebo, Tamsulosin Then Placebo
n=8 Participants
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
|
Tamsulosin Then Placebo, Placebo Then Tamsulosin
n=8 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
less than 55
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Customized
over 55, less than 81
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Every day for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.Population: 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.
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.
Outcome measures
| Measure |
Placebo Then Tamsulosin, Placebo Then Tamsulosin
n=5 Participants
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.
|
Placebo Then Tamsulosin, Tamsulosin Then Placebo
n=7 Participants
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.
|
Tamsulosin Then Placebo, Tamsulosin Then Placebo
n=6 Participants
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
|
Tamsulosin Then Placebo, Placebo Then Tamsulosin
n=8 Participants
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.
|
|---|---|---|---|---|
|
Change in Adapted International Prostate Symptom Score (IPSS)
Tamsulosin
|
13.5 score on a scale
Standard Deviation 9.5
|
12.1 score on a scale
Standard Deviation 8.0
|
14.1 score on a scale
Standard Deviation 7.5
|
9.2 score on a scale
Standard Deviation 6.0
|
|
Change in Adapted International Prostate Symptom Score (IPSS)
Placebo
|
18.7 score on a scale
Standard Deviation 7.5
|
14.3 score on a scale
Standard Deviation 7.9
|
17.6 score on a scale
Standard Deviation 6.4
|
10.9 score on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Daily for 12 weeks. Daily adapted IPSS scores will be averaged over the treatment period.Population: 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
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.
Outcome measures
| Measure |
Placebo Then Tamsulosin, Placebo Then Tamsulosin
n=5 Participants
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.
|
Placebo Then Tamsulosin, Tamsulosin Then Placebo
n=7 Participants
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.
|
Tamsulosin Then Placebo, Tamsulosin Then Placebo
n=6 Participants
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
|
Tamsulosin Then Placebo, Placebo Then Tamsulosin
n=8 Participants
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.
|
|---|---|---|---|---|
|
Medication Side Effect Scale
Tamsulosin
|
0.94 score on a scale
Standard Deviation 1.24
|
2.59 score on a scale
Standard Deviation 1.94
|
1.43 score on a scale
Standard Deviation 2.49
|
1.15 score on a scale
Standard Deviation 1.47
|
|
Medication Side Effect Scale
Placebo
|
1.27 score on a scale
Standard Deviation 1.41
|
2.58 score on a scale
Standard Deviation 1.90
|
1.11 score on a scale
Standard Deviation 1.62
|
1.20 score on a scale
Standard Deviation 1.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-week follow-upIt'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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-week follow-upThe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-week follow-upParticipants 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-week follow-upParticipants 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-week follow-upParticipants were asked several questions regarding their beliefs and attitudes towards deprescribing.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-week follow-upParticipants were asked several questions if they felt that their urinary symptoms were unchanged, improved, or worsened
Outcome measures
Outcome data not reported
Adverse Events
Placebo/Tamsulosin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place