Urinary Retention Postoperative
Conditions
Keywords
urinary retention, thoracic surgery, urinary catheter
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.
Interventions
2 days pre-op, day of surgery, 2 days post-op
OTHERPlacebo
2 days pre-op, day of surgery, 2 days post-op
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
single centre, double blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Rate of Straight Catheterizations | 30 days post-op | Number of Single urinary catheterizations performed |
| 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 |
| 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) |
| Rate of Indwelling Catheterizations | 30 days post-op | Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay |
| Time to first catheterization | up to 30 days post-op | Time to first catheterization |
Countries
Canada
Contacts
Primary ContactDeb Lewis
Outcome results
None listed