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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Tamsulosin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin Hydrochloride | Drug | 2 days pre-op, day of surgery, 2 days post-op |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Effectiveness | Percentage of Screen eligible patients consenting to the study | 4 months |
| Monthly recruitment | Rate of monthly recruitment | 4 months |
| Protocol adherence | Percentage of enrolled patient adherent to protocol during intervention phase | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Straight Catheterizations | Number of Single urinary catheterizations performed | 30 days post-op |
| Rate of Indwelling Catheterizations | Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay |
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Inclusion Criteria ( 2 or more of the following risk factors):
AND
International Prostate Specific Score greater than or equal to 1.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deb Lewis | Contact | 519-685-8500 | 75685 | deb.lewis@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Rahul Nayal | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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single centre, double blind randomized controlled trial
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| Placebo | Other | 2 days pre-op, day of surgery, 2 days post-op |
|
| 30 days post-op |
| Time to first catheterization | Time to first catheterization | up to 30 days post-op |
| 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 |
| 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 |
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |