Prevention of Post-operative Urinary Retention

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.

Conditions

• Urinary Retention
• Urinary Tract Infections

Interventions

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.

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.

Sponsors & Collaborators

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2018-04-01

Completion

2018-05-02

Countries

• United States

Study Locations