About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male Sex
Age greater than or equal to 40 years
History of Diabetes Mellitus
Prior pelvic irradiation
Disqualifiers
Active treatment of Benign Prostatic Hyperplasia (BPH)
Hypersensitivity or allergy to tamsulosin HCL
Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
Active urinary tract infection
Trial design
Parallel
Treatments tested in this trial
Tamsulosin Hydrochloride
Drug2 days pre-op, day of surgery, 2 days post-op
Placebo
Other intervention2 days pre-op, day of surgery, 2 days post-op
Treatment groups
Trial outcomes
Primary outcomes
Enrollment Effectiveness
Percentage of Screen eligible patients consenting to the study
Monthly recruitment
Rate of monthly recruitment
Protocol adherence
Percentage of enrolled patient adherent to protocol during intervention phase
Secondary outcomes
Rate of Straight Catheterizations
Number of Single urinary catheterizations performed
Rate of Indwelling Catheterizations
Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay
Time to first catheterization
Time to first catheterization
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.
Sponsors and contacts
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