Prevention of Post-operative Urinary Retention

Completed · Phase 3 · Has a placebo group

Conditions studied: Urinary Retention, Urinary Tract Infections

In brief

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.

Key facts

Study ID

NCT02486653

Run by

University of Wisconsin, Madison

People needed

158

Starts

2015-08-01

Expected to finish

2018-05-02

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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