NCT06262048 Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
| NCT ID | NCT06262048 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Urinary Retention Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-10-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Rahul Nayal
PRINCIPAL INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Frequently Asked Questions
Who can join the NCT06262048 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Urinary Retention Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06262048 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06262048 currently recruiting?
Yes, NCT06262048 is actively recruiting participants. Contact the research team at deb.lewis@lhsc.on.ca for enrollment information.
Where is the NCT06262048 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06262048 clinical trial?
NCT06262048 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Rahul Nayal at London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The trial plans to enroll 60 participants.