Trial Outcomes & Findings for The Effect of Tamsulosin on Postoperative Urinary Retention (NCT NCT04682366)

NCT ID: NCT04682366

Last Updated: 2024-01-31

Results Overview

Urinary retention can be defined as \>150cc residual volume during an active voiding trial

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

Up to 6 weeks postoperatively

Results posted on

2024-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Tamsulosin Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed. Tamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin	Placebo Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed. Placebo: Oral drug: 10 days of identical-appearing placebo
Overall Study STARTED	2	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tamsulosin Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed. Tamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin	Placebo Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed. Placebo: Oral drug: 10 days of identical-appearing placebo
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

1 Subject was Lost-to-Follow

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamsulosin n=2 Participants Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed. Tamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin	Placebo n=2 Participants Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed. Placebo: Oral drug: 10 days of identical-appearing placebo	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants • 1 Subject was Lost-to-Follow	0 Participants n=1 Participants • 1 Subject was Lost-to-Follow	0 Participants n=2 Participants • 1 Subject was Lost-to-Follow
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants • 1 Subject was Lost-to-Follow	0 Participants n=1 Participants • 1 Subject was Lost-to-Follow	0 Participants n=2 Participants • 1 Subject was Lost-to-Follow
Age, Categorical >=65 years	1 Participants n=1 Participants • 1 Subject was Lost-to-Follow	1 Participants n=1 Participants • 1 Subject was Lost-to-Follow	2 Participants n=2 Participants • 1 Subject was Lost-to-Follow
Sex: Female, Male Female	1 Participants n=1 Participants • 1 Subject in each group was LTF	1 Participants n=1 Participants • 1 Subject in each group was LTF	2 Participants n=2 Participants • 1 Subject in each group was LTF
Sex: Female, Male Male	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=2 Participants • 1 Subject in each group was LTF
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=2 Participants • 1 Subject in each group was LTF
Race (NIH/OMB) Asian	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=2 Participants • 1 Subject in each group was LTF
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=2 Participants • 1 Subject in each group was LTF
Race (NIH/OMB) Black or African American	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=2 Participants • 1 Subject in each group was LTF
Race (NIH/OMB) White	1 Participants n=1 Participants • 1 Subject in each group was LTF	1 Participants n=1 Participants • 1 Subject in each group was LTF	2 Participants n=2 Participants • 1 Subject in each group was LTF
Race (NIH/OMB) More than one race	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=2 Participants • 1 Subject in each group was LTF
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=1 Participants • 1 Subject in each group was LTF	0 Participants n=2 Participants • 1 Subject in each group was LTF
Region of Enrollment United States	1 participants n=2 Participants	1 participants n=2 Participants	2 participants n=4 Participants
Lost to follow-up	1 Participants n=2 Participants	1 Participants n=2 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks postoperatively

Urinary retention can be defined as \>150cc residual volume during an active voiding trial