The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery.
The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery. Primary outcomes being measured are the enrollment rate, protocol adherence rate and participant drop out.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
2 days pre-op, day of surgery, 2 days post-op
2 days pre-op, day of surgery, 2 days post-op
London Health Sciences Centre
London, Ontario, Canada
RECRUITINGEnrollment Effectiveness
Percentage of Screen eligible patients consenting to the study
Time frame: 4 months
Monthly recruitment
Rate of monthly recruitment
Time frame: 4 months
Protocol adherence
Percentage of enrolled patient adherent to protocol during intervention phase
Time frame: 4 Months
Rate of Straight Catheterizations
Number of Single urinary catheterizations performed
Time frame: 30 days post-op
Rate of Indwelling Catheterizations
Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay
Time frame: 30 days post-op
Time to first catheterization
Time to first catheterization
Time frame: up to 30 days post-op
Treatment Related Adverse Events
Unexpected or noxious events that occur as a result of or suspected to be a result of use of the study drug.
Time frame: 30 days post-op
Catheter related complications
Rates of catheter related complications within 30 days of catheterization (e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture)
Time frame: 30 days post-op
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Length of stay
Duration of hospital length of stay will be measured by collecting the date of admission and the date of discharge
Time frame: 30 days post-op