Clincosm LogoSign in Get a demo

POUR: Prevention of Post-operative Urinary Retention

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT02486653
Collaborator
(none)
158
Enrollment
1
Location
2
Arms
33
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery. Post-operative urinary retention is a common post-operative complication, occurring in up to 30% of patients undergoing abdominal surgery. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing post-operative urinary retention. Therefore, in this research study, subjects scheduled for abdominal surgery will be randomly assigned to take either tamsulosin once-daily or placebo once-daily for one week leading up to surgery, and up to several days after surgery. Urinary function will be assessed and compared between these two treatments. The hypothesis is that tamsulosin will reduce the rate of postoperative urinary retention compared to placebo.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Postoperative urinary retention (POUR) complicates up to 30% of general abdominal operations. It results in patient discomfort, embarrassment, interference with therapies, and significant nursing burden. More importantly, urinary retention necessitates use of intermittent catheterization or placement of an indwelling urinary catheter, which exposes the patient to an increased risk of urinary tract infection (UTI), urethral injury, and potentially increased hospital length of stay and cost. For these reasons, a safe and effective intervention for preventing POUR would be highly valuable. Despite such a need, no contemporary studies exist evaluating medications that can be used to prevent POUR in broad general surgery populations. To address this gap, the investigators have designed a prospective, randomized, double-blind, placebo-controlled trial to test the hypothesis that preoperative loading with tamsulosin will prevent POUR in patients undergoing elective, inpatient complex intra-abdominal surgery and thereby lead to improved short-term outcomes.

Tamsulosin is a safe and widely-used selective alpha-1-A adrenergic blocker commonly used for the treatment of lower urinary tract symptoms in men with benign prostatic hypertrophy. It has also been shown to have some benefit in reducing POUR and need for catheterization in men undergoing inguinal hernia repair and other outpatient urologic procedures. This study is a randomized, double-blind, placebo-controlled trial in which patients scheduled for inpatient complex intra-abdominal surgery will be randomized to receive either tamsulosin or placebo for 7 days pre-operatively, and up to several days post-operatively, and then rates of POUR will be compared between the two groups (Aim 1). A retrospective analysis of the data will be used to identify risk factors for POUR and subgroups of patients that would derive the greatest benefit from preoperative tamsulosin (Aim 2). Furthermore, short-term outcomes, including rate of urinary tract infection (UTI) and hospital length of stay, will be compared between the tamsulosin and placebo groups (Aim 3).

Enrolled subjects will be randomized using a blocked, stratified randomization process to either tamsulosin or placebo. Stratification variables include gender, pelvic vs non-pelvic surgery, and International Prostate Symptom Score (IPSS) survey results (which is a measure of baseline lower urinary tract symptoms). After a 7-day treatment period, subjects will undergo surgery as scheduled, and then the assigned treatment will be continued for up to a total of 14 days until the subject either has return of normal voiding function, has required replacement of an indwelling urinary catheter, or is discharged from the hospital.

Study Design

Study Type:
Interventional
Actual Enrollment :
158 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Pre-operative Tamsulosin for the Prevention of Post-operative Urinary Retention: a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
May 2, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tamsulosin

Drug: 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.
Other Names:
  • Flomax

    		•
    Placebo Comparator: Placebo

    Drug: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome [within 0-7 days after surgery]

      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

    Secondary Outcome Measures

    1. Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome [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

    2. Time Until First Spontaneous Void [within 0-7 days after surgery]

      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

    3. Total Number of Intermittent Catheterizations Required Per Subject [within 0-7 days after surgery]

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

    4. First Post-void Residual Urine Volume [within 0-7 days after surgery]

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

    5. Discharge From Hospital With Indwelling Urinary Catheter [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.

    6. Urinary Tract Infection (UTI) [up to 30 days after surgery]

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

    7. Hospital Length of Stay in Days [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

    8. Number of Participants Who Experienced Adverse Events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • English-speaking

    • Able to provide informed consent

    • Scheduled to undergo an elective, complex intra-abdominal operation with a planned postoperative inpatient stay of at least 1 night

    Exclusion Criteria:

    • Less than age 18

    • Allergy or contraindication to tamsulosin

    • Serious sulfa allergy

    • Current use of alpha blocker (alfuzosin, doxazosin, prazosin, silodosin, terazosin, verapamil, tamsulosin) or oral alpha agonist (midodrine), or initiation of one of these medications during the intervention phase of the study will result in subject withdrawal from the study

    • Current warfarin use

    • Pre-existing indwelling urinary catheter, suprapubic catheter, or urostomy

    • End stage renal disease or dialysis-dependence

    • Sitting systolic blood pressure in the upper extremity of less than 100mm Hg at time of eligibility screening

    • Presence of orthostatic hypotension at the time of eligibility screening (orthostatic hypotension is defined as a drop in systolic blood pressure of 20mm Hg from sitting to standing, or drop in diastolic BP of 10 mm Hg from sitting to standing after 2-3 minutes of standing after being in a sitting position)

    • Anticipated inability to take oral medications on post-operative day #0

    • Anticipated requirement for indwelling urinary catheter beyond post-operative day #2

    • Non-English speaking

    • Pregnant or breast-feeding

    • Unwillingness to answer all 7 questions on the IPSS (International Prostate Symptom Score) survey

    • Lacking capacity to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Evie H Carchman, MD, University of Wisconsin - Madison School of Medicine and Public Health

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT02486653
    Other Study ID Numbers:
    • 2014-1494
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of Wisconsin, Madison
    tamsulosin
    randomized controlled trials as topic
    double-blind method
    random allocation
    placebos
    Adrenergic alpha-Antagonists
    urinary retention
    urinary tract infections
    urinary catheters
    catheter-related infections
    postoperative complications
    Additional relevant MeSH terms:
    Infections
    Urinary Tract Infections
    Urinary Retention
    Tamsulosin

    Study Results

    Participant Flow

    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 Detail 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
    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

    Baseline Characteristics

    Arm/Group Title Tamsulosin Placebo Total
    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 Participants 76 75 151
    Age (Count of Participants)
    <=18 years
    1
    1.3%
    0
    0%
    1
    0.7%
    Between 18 and 65 years
    59
    77.6%
    54
    72%
    113
    74.8%
    >=65 years
    16
    21.1%
    21
    28%
    37
    24.5%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.7
    (15.8)
    54.5
    (14.4)
    53.6
    (15.1)
    Sex: Female, Male (Count of Participants)
    Female
    34
    44.7%
    34
    45.3%
    68
    45%
    Male
    42
    55.3%
    41
    54.7%
    83
    55%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    1.3%
    0
    0%
    1
    0.7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    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%
    Unknown or Not Reported
    2
    2.6%
    2
    2.7%
    4
    2.6%
    Region of Enrollment (participants) [Number]
    United States
    76
    100%
    75
    100%
    151
    100%
    IPSS (Count of Participants)
    Low IPSS (Score <=7)
    44
    57.9%
    45
    60%
    89
    58.9%
    High IPSS (Score >7)
    26
    34.2%
    26
    34.7%
    52
    34.4%
    Pelvic Surgery (Count of Participants)
    Non-pelvic Surgery
    30
    39.5%
    32
    42.7%
    62
    41.1%
    Pelvic Surgery
    40
    52.6%
    39
    52%
    79
    52.3%
    Epidural (Count of Participants)
    Epidural used
    25
    32.9%
    16
    21.3%
    41
    27.2%
    No epidural
    45
    59.2%
    55
    73.3%
    100
    66.2%
    ASA Class (Count of Participants)
    ASA Class 1
    3
    3.9%
    1
    1.3%
    4
    2.6%
    ASA Class 2
    48
    63.2%
    55
    73.3%
    103
    68.2%
    ASA Class 3
    19
    25%
    15
    20%
    34
    22.5%
    Body Mass Index (Count of Participants)
    less than 30, non-obese
    38
    50%
    42
    56%
    80
    53%
    greater than or equal to 30, obese
    32
    42.1%
    29
    38.7%
    61
    40.4%
    History of Prior Urinary Retention (Count of Participants)
    Count of Participants [Participants]
    10
    13.2%
    12
    16%
    22
    14.6%
    Smoker (Count of Participants)
    Count of Participants [Participants]
    5
    6.6%
    4
    5.3%
    9
    6%
    COPD (Count of Participants)
    Count of Participants [Participants]
    3
    3.9%
    5
    6.7%
    8
    5.3%
    Hypertension (Count of Participants)
    Count of Participants [Participants]
    28
    36.8%
    30
    40%
    58
    38.4%
    CHF (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    1
    1.3%
    1
    0.7%
    Prior MI (Count of Participants)
    Count of Participants [Participants]
    3
    3.9%
    3
    4%
    6
    4%
    BPH (Count of Participants)
    Count of Participants [Participants]
    3
    3.9%
    1
    1.3%
    4
    2.6%
    Prior CVA (Count of Participants)
    Count of Participants [Participants]
    3
    3.9%
    2
    2.7%
    5
    3.3%
    Diabetes (Count of Participants)
    Count of Participants [Participants]
    10
    13.2%
    7
    9.3%
    17
    11.3%
    IBD (Count of Participants)
    Count of Participants [Participants]
    20
    26.3%
    16
    21.3%
    36
    23.8%

    Outcome Measures

    1. Primary Outcome
    Title Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 70 71
    Count of Participants [Participants]
    18
    23.7%
    22
    29.3%
    2. Secondary Outcome
    Title Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Tamsulosin Placebo
    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.
    Measure Participants 70 71
    Count of Participants [Participants]
    5
    6.6%
    5
    6.7%
    3. Secondary Outcome
    Title Time Until First Spontaneous Void
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 0 0
    4. Secondary Outcome
    Title Total Number of Intermittent Catheterizations Required Per Subject
    Description total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol
    Time Frame within 0-7 days after surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Tamsulosin Placebo
    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.
    Measure Participants 70 71
    At least 1 catheterization
    18
    23.7%
    22
    29.3%
    At least 2 catheterizations
    8
    10.5%
    10
    13.3%
    greater than 2 catheterizations
    0
    0%
    5
    6.7%
    5. Secondary Outcome
    Title First Post-void Residual Urine Volume
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 45 36
    Mean (Standard Deviation) [mL]
    218
    (167)
    154
    (138)
    6. Secondary Outcome
    Title Discharge From Hospital With Indwelling Urinary Catheter
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Tamsulosin Placebo
    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.
    Measure Participants 70 71
    Count of Participants [Participants]
    0
    0%
    0
    0%
    7. Secondary Outcome
    Title Urinary Tract Infection (UTI)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 70 71
    Count of Participants [Participants]
    0
    0%
    1
    1.3%
    8. Secondary Outcome
    Title Hospital Length of Stay in Days
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Tamsulosin Placebo
    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.
    Measure Participants 70 71
    Mean (Standard Deviation) [days]
    6.4
    (3.9)
    6.0
    (3.3)
    9. Secondary Outcome
    Title Number of Participants Who Experienced Adverse Events
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Tamsulosin Placebo
    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.
    Measure Participants 76 75
    Serious Adverse Events
    3
    3.9%
    5
    6.7%
    Other Adverse Events
    10
    13.2%
    8
    10.7%

    Adverse Events

    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
    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 (%) # Events Affected / at Risk (%) # Events
    Total 1/76 (1.3%) 0/75 (0%)
    Serious Adverse Events
    Tamsulosin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/76 (3.9%) 5/75 (6.7%)
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders - Other, specify 0/76 (0%) 0 1/75 (1.3%) 1
    Gastrointestinal disorders
    Abdominal pain 0/76 (0%) 0 1/75 (1.3%) 1
    Intra-abdominal hemorrhage 0/76 (0%) 0 2/75 (2.7%) 2
    Upper gastrointestinal hemorrhage 1/76 (1.3%) 1 0/75 (0%) 0
    Nausea 1/76 (1.3%) 1 0/75 (0%) 0
    Gastrointestinal disorders - Other, specify 1/76 (1.3%) 2 0/75 (0%) 0
    General disorders
    Non-cardiac chest pain 0/76 (0%) 0 1/75 (1.3%) 1
    Death NOS 1/76 (1.3%) 1 0/75 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure 0/76 (0%) 0 1/75 (1.3%) 1
    Surgical and medical procedures
    Surgical and medical procedures - Other, specify 0/76 (0%) 0 1/75 (1.3%) 1
    Other (Not Including Serious) Adverse Events
    Tamsulosin Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/76 (13.2%) 8/75 (10.7%)
    Eye disorders
    Blurred vision 1/76 (1.3%) 1 0/75 (0%) 0
    Gastrointestinal disorders
    Nausea 0/76 (0%) 0 1/75 (1.3%) 1
    Vomiting 0/76 (0%) 0 1/75 (1.3%) 1
    Infections and infestations
    Rhinitis infective 0/76 (0%) 0 1/75 (1.3%) 1
    Nervous system disorders
    Dizziness 6/76 (7.9%) 6 4/75 (5.3%) 4
    Nervous system disorders - Other, specify 1/76 (1.3%) 1 0/75 (0%) 0
    Renal and urinary disorders
    Renal and urinary disorders - Other, specify 1/76 (1.3%) 1 1/75 (1.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion 1/76 (1.3%) 1 0/75 (0%) 0
    Skin and subcutaneous tissue disorders
    Dry skin 0/76 (0%) 0 1/75 (1.3%) 1
    Vascular disorders
    Hypotension 2/76 (2.6%) 2 3/75 (4%) 3

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Evie Carchman, MD
    Organization University of Wisconsin - Madison
    Phone 608-263-2521
    Email carchman@surgery.wisc.edu
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT02486653
    Other Study ID Numbers:
    • 2014-1494
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019