Prevention of Post-operative Urinary Retention
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Overactive Bladder, Infectious Disease, Urology, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/9/2019 |
| Start Date: | August 2015 |
| End Date: | May 2, 2018 |
Pre-operative Tamsulosin for the Prevention of Post-operative Urinary Retention: a Randomized, Double-blind, Placebo-controlled Trial
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.
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.
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.
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.
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
We found this trial at
1
site
600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Evie H Carchman, MD
Phone: 608-262-9134
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