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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

Tracking Information
First Submitted Date  ICMJE June 25, 2015
First Posted Date  ICMJE July 1, 2015
Results First Submitted Date  ICMJE April 4, 2019
Results First Posted Date  ICMJE April 23, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome [ Time Frame: 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 >500mL; or 3) has a post-void residual volume >500mL
Change History Complete list of historical versions of study NCT02486653 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome [ Time Frame: 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
  • Time Until First Spontaneous Void [ Time Frame: 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
  • Total Number of Intermittent Catheterizations Required Per Subject [ Time Frame: within 0-7 days after surgery ]
    total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol
  • First Post-void Residual Urine Volume [ Time Frame: 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
  • Discharge From Hospital With Indwelling Urinary Catheter [ Time Frame: 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.
  • Urinary Tract Infection (UTI) [ Time Frame: 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
  • Hospital Length of Stay in Days [ Time Frame: 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
  • Number of Participants Who Experienced Adverse Events [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
  • Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome [ Time Frame: 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
  • Time Until First Spontaneous Void [ Time Frame: 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
  • Total Number of Intermittent Catheterizations Required Per Subject [ Time Frame: within 0-7 days after surgery ]
    total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol
  • First Post-void Residual Urine Volume [ Time Frame: within 0-7 days after surgery ]
    the post-void residual urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void
  • need for discharge from the hospital with indwelling urinary catheter, binary outcome-- does the subject have a urinary catheter in place at the time of discharge from the hospital? [ Time Frame: up to 30 days after surgery ]
    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
  • Urinary Tract Infection [ Time Frame: 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
  • Hospital Length of Stay in Days [ Time Frame: up to 30 days after surgery ]
    collected after the subject is discharged from the hospital, total number of consecutive days (including day of surgery) until the subject is discharged from the hospital
  • Adverse Events [ Time Frame: treatment day 1 (7 days before surgery) until 30 days after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Post-operative Urinary Retention
Official Title  ICMJE Pre-operative Tamsulosin for the Prevention of Post-operative Urinary Retention: a Randomized, Double-blind, Placebo-controlled Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Urinary Retention
  • Urinary Tract Infections
Intervention  ICMJE
  • 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 Name: Flomax
  • 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.
Study Arms  ICMJE
  • Experimental: Tamsulosin
    Intervention: Drug: Tamsulosin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2019)
158
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2015)
372
Actual Study Completion Date  ICMJE May 2, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02486653
Other Study ID Numbers  ICMJE 2014-1494
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evie H Carchman, MD University of Wisconsin - Madison School of Medicine and Public Health
PRS Account University of Wisconsin, Madison
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP