Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
- Conditions
- Urinary Retention Postoperative
- Interventions
- Other: Placebo
- Registration Number
- NCT06262048
- Lead Sponsor
- Lawson Health Research Institute
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Tamsulosin Hydrochloride Tamsulosin Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Rate of Straight Catheterizations 30 days post-op Number of Single urinary catheterizations performed
Rate of Indwelling Catheterizations 30 days post-op Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay
Catheter related complications 30 days post-op Rates of catheter related complications within 30 days of catheterization (e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture)
Time to first catheterization up to 30 days post-op Time to first catheterization
Treatment Related Adverse Events 30 days post-op Unexpected or noxious events that occur as a result of or suspected to be a result of use of the study drug.
Length of stay 30 days post-op Duration of hospital length of stay will be measured by collecting the date of admission and the date of discharge
Trial Locations
- Locations (1)
London Health Sciences Centre
🇨🇦London, Ontario, Canada