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| Name | Class |
|---|---|
| MaineHealth | OTHER |
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Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.
Postoperative urinary retention (POUR) is a common complication following certain surgical operations. While much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. Early research has indicated that a small dose of tamsulosin (Flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of POUR. Urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. We hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of POUR.
The study is a prospective, double-blind, randomized, placebo-controlled trial. Subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. The primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin | Experimental | Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery. |
|
| Placebo | Placebo Comparator | Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Active drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention | Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed. | Within 2 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of hospital stay | 0-7 days after surgery |
| Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual | Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention? |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anand Rughani, MD | MaineHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States |
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Patients not enrolled included those who did not meet entry criteria (n=150), those who declined to participate (n=140) and those who were not enrolled for other reasons (n=151).
Eligible subjects were enrolled at a neurosurgery outpatient clinic from 2016 to 2019, and included males age 50 to 85 undergoing elective spine surgery at least 5 days after study enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin | Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery. Tamsulosin: Active drug |
| FG001 | Placebo | Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery. Placebo: Lactose-filled capsules identical to active drug |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin | Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery. Tamsulosin: Active drug |
| BG001 | Placebo | Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery. Placebo: Lactose-filled capsules identical to active drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention | Postoperative urinary retention was defined as the need for any postoperative urinary catheterization for acute retention. Per hospital protocol, failure to void 6 hours after surgery or development of bladder discomfort required bladder scan. If bladder volume exceeded 300 cc, catheterization was performed. | Posted | Count of Participants | Participants | Within 2 days after surgery |
|
Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamsulosin | Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery. Tamsulosin: Active drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary issues | Renal and urinary disorders | Non-systematic Assessment | Includes urinary frequency, dribbling, difficulty voiding |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anand Rughani | Maine Medical Center | 207-885-0011 | arughani@mmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2019 | Sep 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Lactose-filled capsules identical to active drug |
|
| Within 2 days after surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| History of hypertension | Count of Participants | Participants |
|
| History of insulin-dependent diabetes mellitus | Count of Participants | Participants |
|
| History of non-insulin dependent diabetes mellitus | Count of Participants | Participants |
|
| History of benign prostatic hyperplasia | Count of Participants | Participants |
|
| Current opioid use | Count of Participants | Participants |
|
| Current smoker | Count of Participants | Participants |
|
| Body mass index > 30 | Count of Participants | Participants |
|
| BMI mean | Mean | Standard Deviation | kg/m^2 |
|
| Office post-void residual < 50 cc | Measurement by ultrasound of the amount of urine remaining in bladder after urinating | Count of Participants | Participants |
|
| Modified International Prostate Symptom Score mean | Scale measures clinical symptoms of prostate enlargement, with range of 0 (no symptoms) to 25 (severe symptoms). | Mean | Standard Deviation | Scores on a scale |
|
| Lumbar spine surgery | Count of Participants | Participants |
|
| Arthrodesis performed | Count of Participants | Participants |
|
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|
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| Secondary | Length of Stay | Length of hospital stay | Posted | Mean | Standard Deviation | days | 0-7 days after surgery |
|
|
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| Secondary | Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual | Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention? | Overall number of participants analyzed in this section (447) is different than total number analyzed overall (497), because PVR was a missing value on 50 patients. This was due to bladder scanner used to measure PVR being inoperable several times over the course of the study. | Posted | Count of Participants | Participants | Within 2 days after surgery |
|
|
|
| 1 |
| 245 |
| 5 |
| 245 |
| 25 |
| 245 |
| EG001 | Placebo | Subjects in this arm will receive a placebo capsule identical in appearance to the tamsulosin capsule, for five days prior to surgery and two days after surgery. Placebo: Lactose-filled capsules identical to active drug | 0 | 252 | 4 | 252 | 15 | 252 |
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Postop neurosurgical complication | Surgical and medical procedures | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment | C. difficile encephalopathy (1) and Urosepsis (1) |
|
|
| Nausea / emesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Cardiac | Cardiac disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |