Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
NCT ID: NCT06262048
Last Updated: 2024-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-10-01
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Treatment
Tamsulosin
Tamsulosin Hydrochloride
2 days pre-op, day of surgery, 2 days post-op
Placebo
Placebo
Placebo
2 days pre-op, day of surgery, 2 days post-op
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Rahul Nayak
MD MSc FRCSC
Principal Investigators
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Rahul Nayal
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Locations
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London Health Sciences Centre
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PrePOURTS
Identifier Type: -
Identifier Source: org_study_id
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