Prevention of Post-operative Urinary Retention
Condition: Urinary Retention; Urinary Tract Infections
MeSH terms: Infections; Urinary Tract Infections; Urinary Retention
Intervention: Tamsulosin; Placebo
Intervention description: 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 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.
Intervention MeSH terms: Tamsulosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

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.
    

Eligibility criteria:

        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