Post-Operative Urinary Retention
Conditions
Keywords
Post-Operative Urinary Retention
Brief summary
This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.
Interventions
DRUGTamsulosin
Tamsulosin may have prophylactic properties against post-operative urinary retention
OTHEREducation
Education about signs and symptoms of urinary retention
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any male age 40 or older * Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic) * Ability to give informed consent
Exclusion criteria
* Current use of alpha blocker * Current use of a strong CYP 3A4 inhibitors * Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications * Patients with any upcoming surgery for cataracts * Currently enrolled in a clinical trial * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Post-operative Urinary Retention | 5 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tamsulosin Group Subjects will receive:
1. 0.4mg tamsulosin by mouth nightly for 3 doses prior to the day of surgery and for 2 doses following surgery
2. education about signs and symptoms of urinary retention
Tamsulosin: Tamsulosin may have prophylactic properties against post-operative urinary retention
Education: Education about signs and symptoms of urinary retention | 1 |
| Education Group Subjects will receive:
1\) education about signs and symptoms of urinary retention
Education: Education about signs and symptoms of urinary retention | 4 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Education Group | Tamsulosin Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 4 participants | 1 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 4 |
| other Total, other adverse events | 0 / 1 | 0 / 4 |
| serious Total, serious adverse events | 0 / 1 | 0 / 4 |
Outcome results
Primary
Number of Participants With Post-operative Urinary Retention
Time frame: 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tamsulosin Group | Number of Participants With Post-operative Urinary Retention | 0 Participants |
| Education Group | Number of Participants With Post-operative Urinary Retention | 0 Participants |