Urinary Retention Postoperative Clinical Trial
— PrePOURTSOfficial title:
Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing pulmonary surgery.
Status | Not yet recruiting |
Enrollment | 64 |
Est. completion date | May 31, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of post operative urinary retention | defined as requiring straight or indwelling catheterization at any point in the post-operative period | 30 days post-op | |
Secondary | Rate of Straight Catheterizations | Number of Single urinary catheterizations performed | 30 days post-op | |
Secondary | Rate of Indwelling Catheterizations | Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay | 30 days post-op | |
Secondary | Time to first catheterization | Time to first catheterization | up to 30 days post-op | |
Secondary | Treatment Related Adverse Events | Unexpected or noxious events that occur as a result of or suspected to be a result of use of the study drug. | 30 days post-op | |
Secondary | Catheter related complications | Rates of catheter related complications within 30 days of catheterization (e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture) | 30 days post-op | |
Secondary | Length of stay | Duration of hospital length of stay will be measured by collecting the date of admission and the date of discharge | 30 days post-op |
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