Phase 3
N=151
Prevention of Post-operative Urinary Retention
Urinary Retention · Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT02486653 ↗Enrolled (actual)
151
Serious AEs
5.3%
Results posted
Apr 2019
Primary outcome: Primary: Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome — 18; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tamsulosin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome |
18; 22 | — |
| SECONDARY Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome |
5; 5 | — |
| SECONDARY Time Until First Spontaneous Void |
— | — |
| SECONDARY Total Number of Intermittent Catheterizations Required Per Subject |
18; 22; 8; 10; 0; 5 | — |
| SECONDARY First Post-void Residual Urine Volume |
218; 154 | — |
| SECONDARY Discharge From Hospital With Indwelling Urinary Catheter |
0; 0 | — |
| SECONDARY Urinary Tract Infection (UTI) |
0; 1 | — |
| SECONDARY Hospital Length of Stay in Days |
6.4; 6.0 | — |
| SECONDARY Number of Participants Who Experienced Adverse Events |
3; 5; 10; 8 | — |
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
Data sourced from ClinicalTrials.gov (NCT02486653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.