Reducing urinary retention after thoracic surgery
Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility Trial
This study is testing if the medication tamsulosin can help prevent urinary retention after thoracic surgery compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06262048 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of a larger randomized control trial that will compare the effectiveness of tamsulosin, a medication, against a placebo in preventing post-operative urinary retention in patients undergoing elective thoracic surgery. The primary outcomes include measuring the enrollment rate, adherence to the study protocol, and participant dropout rates. By evaluating these factors, the study seeks to lay the groundwork for future research on this important post-surgical complication.
Who should consider this trial
Good fit: Ideal candidates include males aged 40 and older with specific risk factors such as a history of diabetes or prior urinary retention.
Not a fit: Patients currently undergoing treatment for benign prostatic hyperplasia or those with active urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of urinary retention in patients after thoracic surgery, enhancing recovery and patient comfort.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in managing post-operative urinary retention, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London, Ontario
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Rahul Nayal — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study coordinator: Deb Lewis
- Email: deb.lewis@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.