Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Feb 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a medication called tamsulosin to see if it can help prevent urinary retention (the inability to fully empty the bladder) in patients after they have thoracic surgery, which involves operations on the chest area. The researchers want to find out if tamsulosin is more effective than a placebo (a harmless sugar pill) in reducing this problem. The study is currently recruiting participants who are at risk for urinary retention, such as men aged 40 and older, those with diabetes, or individuals who have had certain types of pelvic treatment.

If you or a loved one are considering joining this trial, you should know that eligibility includes having two or more specific risk factors, like being male or having a history of urinary retention. Participants will receive either tamsulosin or a placebo and will be monitored for any changes in their ability to urinate after surgery. It's important to note that certain health conditions or treatments could exclude someone from participating, such as having an active urinary infection or a history of specific urological surgeries. This trial could be a significant step toward improving recovery for patients undergoing thoracic surgery.

Gender

ALL

Eligibility criteria

• 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