Tamsulosin Hydrochloride: 2 days pre-op, day of surgery, 2 days post-op
Placebo: 2 days pre-op, day of surgery, 2 days post-op
Study summary
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
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria ( 2 or more of the following risk factors):
* Male Sex
* Age greater than or equal to 40 years
* History of Diabetes Mellitus
* Prior pelvic irradiation
* Use of indwelling Thoracic Epidural analgesia
* Prior history of urinary retention
AND
International Prostate Specific Score greater than or equal to 1.
Exclusion Criteria:
* 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
* History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy.
* History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
* Underlying neurological disorders resulting in impaired bladder function
* Any known contraindication to the use of tamsulosin HCL
* Nursing/ Breastfeeding women
* Use of intraoperative bladder catheter
* patients for whom cataract and/or glaucoma surgery is scheduled.
* patients on strong inhibitors of CYP3A4 (e.g., ketoconazole), on moderate inhibitors of CYP3A4 (e.g., erythromycin), on strong (e.g. paroxetine), on moderate (e.g., terbinafine) inhibitors of CYP2D6 or in patients known to be CYP2D6 poor metabolizers.
* patients with a serious or life-threatening sulfa allergy
* patients with severe hepatic insufficiency
* patients with severe renal impairment (creatinine clearance of \<10 mL/min)
* patients with a serious or life-threatening sulfa allergy
Primary outcome measure(s)
Enrollment Effectiveness — 4 months Percentage of Screen eligible patients consenting to the study
Monthly recruitment — 4 months Rate of monthly recruitment
Protocol adherence — 4 Months Percentage of enrolled patient adherent to protocol during intervention phase
Trial sites (1)
Facility
City
Region
Status
London Health Sciences Centre
London
Ontario
Recruiting
More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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