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Slow recruitment and enrollment
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Postoperative urinary retention is a frequent complication of spinal surgeries and impacts a large portion of this population which results in increased morbidity as a result of increased number of catheterizations, urinary tract infections (UTIs) and prolonged hospital stays. With the addition of Tamsulosin, the investigators would anticipate a reduction in the incidence and duration of postoperative urinary retention and therefore a reduction in morbidity related to treatment of urinary retention as well as shortened hospital stays.
Decompressive laminectomy and spinal fusion procedures are among the most common neurosurgical procedures performed. Postoperative urinary retention (POUR) is a frequent complication of such surgeries and impacts a large proportion of this population resulting in multiple intermittent bladder catheterizations for bladder decompression, increased incidence of bacteremia, increased incidence of UTIs, and prolonged hospital stays. Use of a uroselective alpha-1-adrenergic receptor antagonist, such as tamsulosin, in the perioperative period (medication started five days prior to surgery and taken until hospital discharge) could reduce both the incidence and duration of postoperative urinary retention, resulting in shorter hospital stays and decreased healthcare costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin | Experimental | Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. |
|
| Placebo | Placebo Comparator | Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin hydrochloride | Drug | Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Urinary Retention | Post operative urinary retention (POUR) will be defined as any of the following: 1) Estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; 2) Estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; 3) Patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml. | participants will be followed for the duration of the hospital stay, an expected average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Postoperative Urinary Retention | The neurosurgical team will decide if an indwelling urinary catheter will be used. Time of indwelling catheter removal after surgery will serve as time zero for beginning calculation of postoperative urinary retention duration if the patient later requires in and out straight catheterization. For patients without an indwelling catheter, the time patients leave the operating room will serve as time zero. Urinary retention will be considered resolved after two consecutive post-void residual urine scans have demonstrated less than 300 ml residual urine volume in a patient spontaneously voiding. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Clarke, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Clinical Trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin | Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. |
| FG001 | Placebo | Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin | Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. |
| BG001 |
| 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 | Incidence of Postoperative Urinary Retention | Post operative urinary retention (POUR) will be defined as any of the following: 1) Estimated post-void residual (PVR) volume of urine greater than or equal to 300 mL; 2) Estimated retention urine volume of greater than or equal to 500 mL in patients unable to void; 3) Patients experiencing discomfort or distension and unable to void with lesser residual urine volume than 500 ml. | Posted | Count of Participants | Participants | participants will be followed for the duration of the hospital stay, an expected average of 5 days |
|
Adverse events were collected from baseline to first follow-up postop (approximately 3 months) on all participants.
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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 | Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. Tamsulosin hydrochloride: Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Extremity Edema | General disorders | Systematic Assessment |
Terminated study due to slow recruitment and enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Clarke, M.D. | Mayo Clinic | (507) 284-5317 | Clarke.Michelle@mayo.edu |
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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 | Feb 1, 2012 | Apr 26, 2024 | 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 | Other | The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge. |
|
| participants will be followed for the duration of the hospital stay, an expected average of 5 days |
| Placebo |
Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge. |
|
|
| Secondary | Duration of Postoperative Urinary Retention | The neurosurgical team will decide if an indwelling urinary catheter will be used. Time of indwelling catheter removal after surgery will serve as time zero for beginning calculation of postoperative urinary retention duration if the patient later requires in and out straight catheterization. For patients without an indwelling catheter, the time patients leave the operating room will serve as time zero. Urinary retention will be considered resolved after two consecutive post-void residual urine scans have demonstrated less than 300 ml residual urine volume in a patient spontaneously voiding. | Posted | Mean | Standard Deviation | days | participants will be followed for the duration of the hospital stay, an expected average of 5 days |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Placebo | Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge. Placebo: The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge. | 0 | 51 | 0 | 51 | 1 | 51 |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |