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Prevention of Post-operative Urinary Retention (POUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02486653
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : April 23, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Urinary Retention
Urinary Tract Infections
Interventions Drug: Tamsulosin
Drug: Placebo
Enrollment 158
Recruitment Details Recruitment began in August 2015 and continued until Feb 2018. Subjects were recruited from surgery clinics at a single university hospital.
Pre-assignment Details 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
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description

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 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.
Period Title: Overall Study
Started 76 75
Completed 70 71
Not Completed 6 4
Reason Not Completed
Withdrawal by Subject             1             3
Protocol Violation             1             0
surgery cancelled             4             1
Arm/Group Title Tamsulosin Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 76 75 151
Hide Baseline Analysis Population Description
76 subjects randomized to Tamsulosin; 4 surgery cancelled, 1 withdrew prior to starting study drug, 1 had intraoperative urethral injury precluding ability to collect outcome data, therefore analysis population was 70 subjects. 75 randomized to Placebo; 3 withdrew prior to starting study drug, 1 surgery cancelled, therefore analysis pop. was 71
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
<=18 years
1
   1.3%
0
   0.0%
1
   0.7%
Between 18 and 65 years
59
  77.6%
54
  72.0%
113
  74.8%
>=65 years
16
  21.1%
21
  28.0%
37
  24.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 75 participants 151 participants
52.7  (15.8) 54.5  (14.4) 53.6  (15.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
Female
34
  44.7%
34
  45.3%
68
  45.0%
Male
42
  55.3%
41
  54.7%
83
  55.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 75 participants 151 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.3%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
73
  96.1%
73
  97.3%
146
  96.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.6%
2
   2.7%
4
   2.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 75 participants 151 participants
76 75 151
IPSS   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
Low IPSS (Score <=7)
44
  62.9%
45
  63.4%
89
  63.1%
High IPSS (Score >7)
26
  37.1%
26
  36.6%
52
  36.9%
[1]
Measure Description: IPSS is the International Prostate Symptom Score. This is a validated 7-question survey that characterizes severity of lower urinary tract symptoms. The score ranges from 0-35, with high scores indicating more significant symptoms (i.e. weak stream, urinary frequency, needing to strain to begin urination, etc). This is a self-completed survey filled out by the subject.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
Non-pelvic Surgery
30
  42.9%
32
  45.1%
62
  44.0%
Pelvic Surgery
40
  57.1%
39
  54.9%
79
  56.0%
[1]
Measure Description: "Pelvic Surgery" was defined as surgical procedure involving dissection/resection/anastomosis involving the rectum or pelvis.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
Epidural used
25
  35.7%
16
  22.5%
41
  29.1%
No epidural
45
  64.3%
55
  77.5%
100
  70.9%
[1]
Measure Description: This baseline characteristic describes whether or not an epidural was used for postoperative analgesia
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
ASA Class 1
3
   4.3%
1
   1.4%
4
   2.8%
ASA Class 2
48
  68.6%
55
  77.5%
103
  73.0%
ASA Class 3
19
  27.1%
15
  21.1%
34
  24.1%
[1]
Measure Description:

American Society of Anesthesiologists (ASA) Classification characterizes baseline comorbidities of patients undergoing surgery:

Class 1- normal healthy patient Class 2- Mild systemic disease Class 3- Severe systemic disease

[2]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
less than 30, non-obese
38
  54.3%
42
  59.2%
80
  56.7%
greater than or equal to 30, obese
32
  45.7%
29
  40.8%
61
  43.3%
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
10
  14.3%
12
  16.9%
22
  15.6%
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
5
   7.1%
4
   5.6%
9
   6.4%
[1]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
3
   4.3%
5
   7.0%
8
   5.7%
[1]
Measure Description: Chronic Obstructive Pulmonary Disease (COPD)
[2]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
28
  40.0%
30
  42.3%
58
  41.1%
[1]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
0
   0.0%
1
   1.4%
1
   0.7%
[1]
Measure Description: Congestive heart failure (CHF)
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
3
   4.3%
3
   4.2%
6
   4.3%
[1]
Measure Description: Myocardial infarction (MI)
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
3
   4.3%
1
   1.4%
4
   2.8%
[1]
Measure Description: Benign prostatic hyperplasia (BPH)
[2]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
3
   4.3%
2
   2.8%
5
   3.5%
[1]
Measure Description: Cerebrovascular accident (CVA)
[2]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
10
  14.3%
7
   9.9%
17
  12.1%
[1]
Measure Analysis Population Description: 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   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 71 participants 141 participants
20
  28.6%
16
  22.5%
36
  25.5%
[1]
Measure Description: Inflammatory bowel disease (IBD)
[2]
Measure Analysis Population Description: 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.Primary Outcome
Title Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome
Hide Description 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
Time Frame within 0-7 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 70 71
Measure Type: Count of Participants
Unit of Measure: Participants
18
  25.7%
22
  31.0%
2.Secondary Outcome
Title Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome
Hide Description 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
Time Frame within 0-7 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 70 71
Measure Type: Count of Participants
Unit of Measure: Participants
5
   7.1%
5
   7.0%
3.Secondary Outcome
Title Time Until First Spontaneous Void
Hide Description 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
Time Frame within 0-7 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Total Number of Intermittent Catheterizations Required Per Subject
Hide Description total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol
Time Frame within 0-7 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 70 71
Measure Type: Count of Participants
Unit of Measure: Participants
At least 1 catheterization
18
  25.7%
22
  31.0%
At least 2 catheterizations
8
  11.4%
10
  14.1%
greater than 2 catheterizations
0
   0.0%
5
   7.0%
5.Secondary Outcome
Title First Post-void Residual Urine Volume
Hide Description The post-void residual (PVR) urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void
Time Frame within 0-7 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Only includes subjects who were NOT straight-catheterized AND there were 20 additional subjects for which PVR was not recorded
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 45 36
Mean (Standard Deviation)
Unit of Measure: mL
218  (167) 154  (138)
6.Secondary Outcome
Title Discharge From Hospital With Indwelling Urinary Catheter
Hide Description 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.
Time Frame up to 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 70 71
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Urinary Tract Infection (UTI)
Hide Description Either a culture-positive UTI prior to discharge from the hospital or subject self-reported clinician-diagnosed UTI occurring within 30 days of surgery
Time Frame up to 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
This participant did not have urinary retention; self-reported UTI, catheter was removed on post operative day #2
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 70 71
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.4%
8.Secondary Outcome
Title Hospital Length of Stay in Days
Hide Description 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
Time Frame up to 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 70 71
Mean (Standard Deviation)
Unit of Measure: days
6.4  (3.9) 6.0  (3.3)
9.Secondary Outcome
Title Number of Participants Who Experienced Adverse Events
Hide Description Adverse events, systematically collected. Summary results reported here, please refer to Adverse Events section of the results record for detailed reporting.
Time Frame treatment day 1 (7 days before surgery) until 30 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description:
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: 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.
Overall Number of Participants Analyzed 76 75
Measure Type: Count of Participants
Unit of Measure: Participants
Serious Adverse Events
3
   3.9%
5
   6.7%
Other Adverse Events
10
  13.2%
8
  10.7%
Time Frame treatment day 1 (7 days before surgery) until 30 days after surgery
Adverse Event Reporting Description 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).
 
Arm/Group Title Tamsulosin Placebo
Hide Arm/Group Description

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 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.
All-Cause Mortality
Tamsulosin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/76 (1.32%)      0/75 (0.00%)    
Hide Serious Adverse Events
Tamsulosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/76 (3.95%)      5/75 (6.67%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders - Other, specify  [1]  0/76 (0.00%)  0 1/75 (1.33%)  1
Gastrointestinal disorders     
Abdominal pain   0/76 (0.00%)  0 1/75 (1.33%)  1
Intra-abdominal hemorrhage   0/76 (0.00%)  0 2/75 (2.67%)  2
Upper gastrointestinal hemorrhage   1/76 (1.32%)  1 0/75 (0.00%)  0
Nausea   1/76 (1.32%)  1 0/75 (0.00%)  0
Gastrointestinal disorders - Other, specify  [2]  1/76 (1.32%)  2 0/75 (0.00%)  0
General disorders     
Non-cardiac chest pain   0/76 (0.00%)  0 1/75 (1.33%)  1
Death NOS  [3]  1/76 (1.32%)  1 0/75 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory failure   0/76 (0.00%)  0 1/75 (1.33%)  1
Surgical and medical procedures     
Surgical and medical procedures - Other, specify  [4]  0/76 (0.00%)  0 1/75 (1.33%)  1
Indicates events were collected by systematic assessment
[1]
supratherapeutic on Lovenox leading to spontaneous rectus sheath hematoma
[2]
Ileus/SBO
[3]
Subject had gastric cancer, died from advanced cancer
[4]
Bleeding requiring return to the operating room
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tamsulosin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/76 (13.16%)      8/75 (10.67%)    
Eye disorders     
Blurred vision   1/76 (1.32%)  1 0/75 (0.00%)  0
Gastrointestinal disorders     
Nausea   0/76 (0.00%)  0 1/75 (1.33%)  1
Vomiting   0/76 (0.00%)  0 1/75 (1.33%)  1
Infections and infestations     
Rhinitis infective  [1]  0/76 (0.00%)  0 1/75 (1.33%)  1
Nervous system disorders     
Dizziness   6/76 (7.89%)  6 4/75 (5.33%)  4
Nervous system disorders - Other, specify  [2]  1/76 (1.32%)  1 0/75 (0.00%)  0
Renal and urinary disorders     
Renal and urinary disorders - Other, specify  [3]  1/76 (1.32%)  1 1/75 (1.33%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal congestion   1/76 (1.32%)  1 0/75 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin   0/76 (0.00%)  0 1/75 (1.33%)  1
Vascular disorders     
Hypotension   2/76 (2.63%)  2 3/75 (4.00%)  3
Indicates events were collected by systematic assessment
[1]
Runny nose
[2]
Tingling sensation
[3]
Frequent urge to urinate
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Evie Carchman, MD
Organization: University of Wisconsin - Madison
Phone: 608-263-2521
EMail: carchman@surgery.wisc.edu
Publications:
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02486653    
Other Study ID Numbers: 2014-1494
First Submitted: June 25, 2015
First Posted: July 1, 2015
Results First Submitted: April 4, 2019
Results First Posted: April 23, 2019
Last Update Posted: September 25, 2019