Trial Outcomes & Findings for Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention (NCT NCT02684344)

NCT ID: NCT02684344

Last Updated: 2019-01-23

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

5 days

Results posted on

2019-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Tamsulosin Group Subjects will receive: 1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery 2. education about signs and symptoms of urinary retention Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention	Education Group Subjects will receive: 1\) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention
Overall Study STARTED	1	4
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tamsulosin Group Subjects will receive: 1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery 2. education about signs and symptoms of urinary retention Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention	Education Group Subjects will receive: 1\) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 5 days

Outcome measures

Outcome measures
Measure	Tamsulosin Group n=1 Participants Subjects will receive: 1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery 2. education about signs and symptoms of urinary retention Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention	Education Group n=4 Participants Subjects will receive: 1\) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention
Number of Participants With Post-operative Urinary Retention	0 Participants	0 Participants

Adverse Events

Tamsulosin Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education Group

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

Edward Messing

University of Rochester

Phone: 585 - 275 - 0998

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Tamsulosin Group n=1 Participants Subjects will receive: 1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery 2. education about signs and symptoms of urinary retention Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention Education: Education about signs and symptoms of urinary retention	Education Group n=4 Participants Subjects will receive: 1\) education about signs and symptoms of urinary retention Education: Education about signs and symptoms of urinary retention	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants