Trial Outcomes & Findings for Prevention of Post-operative Urinary Retention (NCT NCT02486653)

NCT ID: NCT02486653

Last Updated: 2019-09-25

Results Overview

need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for \>500milliliters; or 3) has a post-void residual volume \>500milliliters

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 158 participants
• Primary outcome timeframe: within 0-7 days after surgery
• Results posted on: 2019-09-25

Participant Flow

Recruitment began in August 2015 and continued until Feb 2018. Subjects were recruited from surgery clinics at a single university hospital.

Subjects were randomized within 1 month of their surgery date but >7 days prior to surgery. 7 participants were not randomized for the following reasons: 4 subjects self-withdraw prior to randomization; 3 subjects had surgery date moved up to within the 7-day window before surgery

Participant milestones

Measure	Tamsulosin Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: tamsulosin 0.4mg in the evening * Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.	Placebo Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: placebo in the evening * Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.
Overall Study STARTED	76	75
Overall Study COMPLETED	70	71
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Measure	Tamsulosin Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: tamsulosin 0.4mg in the evening * Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.	Placebo Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: placebo in the evening * Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	1	0
Overall Study surgery cancelled	4	1

Baseline Characteristics

These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.

Baseline characteristics by cohort

Measure	Tamsulosin n=76 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: tamsulosin 0.4mg in the evening * Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.	Placebo n=75 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: placebo in the evening * Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.	Total n=151 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=76 Participants	0 Participants n=75 Participants	1 Participants n=151 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=76 Participants	54 Participants n=75 Participants	113 Participants n=151 Participants
Age, Categorical >=65 years	16 Participants n=76 Participants	21 Participants n=75 Participants	37 Participants n=151 Participants
Age, Continuous	52.7 years STANDARD_DEVIATION 15.8 • n=76 Participants	54.5 years STANDARD_DEVIATION 14.4 • n=75 Participants	53.6 years STANDARD_DEVIATION 15.1 • n=151 Participants
Sex: Female, Male Female	34 Participants n=76 Participants	34 Participants n=75 Participants	68 Participants n=151 Participants
Sex: Female, Male Male	42 Participants n=76 Participants	41 Participants n=75 Participants	83 Participants n=151 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=76 Participants	0 Participants n=75 Participants	0 Participants n=151 Participants
Race (NIH/OMB) Asian	1 Participants n=76 Participants	0 Participants n=75 Participants	1 Participants n=151 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=76 Participants	0 Participants n=75 Participants	0 Participants n=151 Participants
Race (NIH/OMB) Black or African American	0 Participants n=76 Participants	0 Participants n=75 Participants	0 Participants n=151 Participants
Race (NIH/OMB) White	73 Participants n=76 Participants	73 Participants n=75 Participants	146 Participants n=151 Participants
Race (NIH/OMB) More than one race	0 Participants n=76 Participants	0 Participants n=75 Participants	0 Participants n=151 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=76 Participants	2 Participants n=75 Participants	4 Participants n=151 Participants
Region of Enrollment United States	76 participants n=76 Participants	75 participants n=75 Participants	151 participants n=151 Participants
IPSS Low IPSS (Score <=7)	44 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	45 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	89 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
IPSS High IPSS (Score >7)	26 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	26 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	52 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Pelvic Surgery Non-pelvic Surgery	30 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	32 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	62 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Pelvic Surgery Pelvic Surgery	40 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	39 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	79 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Epidural Epidural used	25 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	16 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	41 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Epidural No epidural	45 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	55 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	100 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
ASA Class ASA Class 1	3 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	1 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	4 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
ASA Class ASA Class 2	48 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	55 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	103 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
ASA Class ASA Class 3	19 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	15 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	34 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Body Mass Index less than 30, non-obese	38 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	42 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	80 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Body Mass Index greater than or equal to 30, obese	32 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	29 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	61 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
History of Prior Urinary Retention	10 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	12 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	22 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Smoker	5 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	4 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	9 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
COPD	3 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	5 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	8 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Hypertension	28 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	30 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	58 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
CHF	0 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	1 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	1 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Prior MI	3 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	3 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	6 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
BPH	3 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	1 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	4 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Prior CVA	3 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	2 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	5 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
Diabetes	10 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	7 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	17 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.
IBD	20 Participants n=70 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	16 Participants n=71 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.	36 Participants n=141 Participants • These are the baseline characteristics for the subjects who completed the study (and for whom there is outcomes data). Of the 151 subjects randomized, 4 withdrew prior to starting study med, 5 had surgery cancelled, and 1 had an intraop complication precluding any collection of outcomes data, yielding a total of 141 subjects.

PRIMARY outcome

Timeframe: within 0-7 days after surgery

Population: This is an intent-to-treat analysis, including all subjects who were randomized and did not withdraw prior to the intended start date of their study drug.

need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for >500milliliters; or 3) has a post-void residual volume >500milliliters

Outcome measures

Measure	Tamsulosin n=70 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.	Placebo n=71 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome	18 Participants	22 Participants

SECONDARY outcome

Timeframe: within 0-7 days after surgery

Need for replacement of an IUC after surgery or after initial removal of an IUC that was placed at the time of surgery; replacement of IUC is dictated by the institutional bladder management protocol after requiring the use of straight catheterization for 24 hours

Outcome measures

Measure	Tamsulosin n=70 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.	Placebo n=71 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome	5 Participants	5 Participants

SECONDARY outcome

Timeframe: within 0-7 days after surgery

Population: Time to first spontaneous void was not collected as this is not relevant clinically to diagnosis of urinary retention, and our bladder management protocol prevents unbiased collection of this data point.

time from IUC removal, last intermittent catheterization (if performed in the operating room or post-anesthesia care unit), or departure from the operating room (if no IUC placed intraoperatively) until first spontaneous void

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 0-7 days after surgery

total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol

Outcome measures

Measure	Tamsulosin n=70 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.	Placebo n=71 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Total Number of Intermittent Catheterizations Required Per Subject At least 1 catheterization	18 Participants	22 Participants
Total Number of Intermittent Catheterizations Required Per Subject At least 2 catheterizations	8 Participants	10 Participants
Total Number of Intermittent Catheterizations Required Per Subject greater than 2 catheterizations	0 Participants	5 Participants

SECONDARY outcome

Timeframe: within 0-7 days after surgery

Population: Only includes subjects who were NOT straight-catheterized AND there were 20 additional subjects for which PVR was not recorded

The post-void residual (PVR) urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void

Outcome measures

Measure	Tamsulosin n=45 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.	Placebo n=36 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
First Post-void Residual Urine Volume	218 mL Standard Deviation 167	154 mL Standard Deviation 138

SECONDARY outcome

Timeframe: up to 30 days after surgery

Does the subject have a urinary catheter in place at the time of discharge from the hospital? This is a binary outcome measure of whether or not the subject is discharged from the hospital with an indwelling urinary catheter in place due to inadequate voiding function.

Outcome measures

Measure	Tamsulosin n=70 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.	Placebo n=71 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Discharge From Hospital With Indwelling Urinary Catheter	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 30 days after surgery

Population: This participant did not have urinary retention; self-reported UTI, catheter was removed on post operative day #2

Either a culture-positive UTI prior to discharge from the hospital or subject self-reported clinician-diagnosed UTI occurring within 30 days of surgery

Outcome measures

Measure	Tamsulosin n=70 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.	Placebo n=71 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Urinary Tract Infection (UTI)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 30 days after surgery

Collected after the participant is discharged from the hospital, total number of consecutive days (including day of surgery) until the participant is discharged from the hospital

Outcome measures

Measure	Tamsulosin n=70 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.	Placebo n=71 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Hospital Length of Stay in Days	6.4 days Standard Deviation 3.9	6.0 days Standard Deviation 3.3

SECONDARY outcome

Timeframe: treatment day 1 (7 days before surgery) until 30 days after surgery

Adverse events, systematically collected. Summary results reported here, please refer to Adverse Events section of the results record for detailed reporting.

Outcome measures

Measure	Tamsulosin n=76 Participants Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.	Placebo n=75 Participants Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
Number of Participants Who Experienced Adverse Events Serious Adverse Events	3 Participants	5 Participants
Number of Participants Who Experienced Adverse Events Other Adverse Events	10 Participants	8 Participants

Adverse Events

Tamsulosin

Serious events: 3 serious events

Other events: 10 other events

Deaths: 1 deaths

Placebo

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tamsulosin n=76 participants at risk Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: tamsulosin 0.4mg in the evening * Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.	Placebo n=75 participants at risk Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: placebo in the evening * Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Gastrointestinal disorders Abdominal pain	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Surgical and medical procedures Surgical and medical procedures - Other, specify	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	2.7% 2/75 • Number of events 2 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
General disorders Non-cardiac chest pain	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.3% 1/76 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	0.00% 0/75 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
General disorders Death NOS	1.3% 1/76 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	0.00% 0/75 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Gastrointestinal disorders Nausea	1.3% 1/76 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	0.00% 0/75 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.3% 1/76 • Number of events 2 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	0.00% 0/75 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).

Other adverse events

Measure	Tamsulosin n=76 participants at risk Tamsulosin: Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: tamsulosin 0.4mg in the evening * Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.	Placebo n=75 participants at risk Placebo: Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively. Outline of schedule: * Day 1-7: placebo in the evening * Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol * Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual \<200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function.
Eye disorders Blurred vision	1.3% 1/76 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	0.00% 0/75 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Nervous system disorders Dizziness	7.9% 6/76 • Number of events 6 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	5.3% 4/75 • Number of events 4 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Vascular disorders Hypotension	2.6% 2/76 • Number of events 2 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	4.0% 3/75 • Number of events 3 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.3% 1/76 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	0.00% 0/75 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Gastrointestinal disorders Nausea	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Nervous system disorders Nervous system disorders - Other, specify	1.3% 1/76 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	0.00% 0/75 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Renal and urinary disorders Renal and urinary disorders - Other, specify	1.3% 1/76 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Gastrointestinal disorders Vomiting	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).
Infections and infestations Rhinitis infective	0.00% 0/76 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).	1.3% 1/75 • Number of events 1 • treatment day 1 (7 days before surgery) until 30 days after surgery Adverse Events were systematically collected at 3 time points (on the day of surgery from interview of the subject; during hospitalization by chart review; and 30 days after surgery from interview of the subject).

Additional Information

Dr. Evie Carchman, MD

University of Wisconsin - Madison

Phone: 608-263-2521

Email: carchman@surgery.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place