Post-operative Urinary Retention
Conditions
Brief summary
Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.
Detailed description
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.
Interventions
DRUGTamsulosin
Active drug
DRUGPlacebo
Lactose-filled capsules identical to active drug
Sponsors
MaineHealth
Anand Rughani, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male patient age 50 - 85 years * Undergoing elective spine surgery at least 5 days after enrollment * Preop visit done at office practice
Exclusion criteria
* Currently on tamsulosin or other alpha-adrenergic blocking drug * Allergy to tamsulosin * Allergy to lactose * Serious or life-threatening allergy to sulfa drugs * Emergent procedure * History of spinal trauma, spinal infection or spinal cord tumor * Pre-existing indwelling urinary catheter * History of orthostatic hypotension or current orthostatic hypotension * History of prostate, urethral or bladder surgery * Renal failure * Non-English speaking * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention | Within 2 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 0-7 days after surgery | Length of hospital stay |
| Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual | Within 2 days after surgery | Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention? |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 245 |
| 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 | 252 |
| Total | 497 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not undergo surgery | 16 | 20 |
| Overall Study | Enrolled before trial registration | 44 | 33 |
Baseline characteristics
| Characteristic | Total | Tamsulosin | Placebo |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 8.1 | 63.4 years STANDARD_DEVIATION 7.7 | 63.7 years STANDARD_DEVIATION 8.7 |
| Arthrodesis performed | 128 Participants | 66 Participants | 62 Participants |
| BMI mean | 31.1 kg/m^2 STANDARD_DEVIATION 5.6 | 30.9 kg/m^2 STANDARD_DEVIATION 5.7 | 31.1 kg/m^2 STANDARD_DEVIATION 5.6 |
| Body mass index > 30 | 266 Participants | 130 Participants | 136 Participants |
| Current opioid use | 107 Participants | 55 Participants | 52 Participants |
| Current smoker | 84 Participants | 48 Participants | 36 Participants |
| History of benign prostatic hyperplasia | 38 Participants | 15 Participants | 23 Participants |
| History of hypertension | 328 Participants | 165 Participants | 163 Participants |
| History of insulin-dependent diabetes mellitus | 40 Participants | 21 Participants | 19 Participants |
| History of non-insulin dependent diabetes mellitus | 108 Participants | 59 Participants | 49 Participants |
| Lumbar spine surgery | 374 Participants | 175 Participants | 199 Participants |
| Modified International Prostate Symptom Score mean | 5.0 Scores on a scale STANDARD_DEVIATION 4.4 | 5.1 Scores on a scale STANDARD_DEVIATION 4.6 | 4.9 Scores on a scale STANDARD_DEVIATION 4.2 |
| Office post-void residual < 50 cc | 291 Participants | 141 Participants | 150 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 497 Participants | 245 Participants | 252 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 245 | 0 / 252 |
| other Total, other adverse events | 25 / 245 | 15 / 252 |
| serious Total, serious adverse events | 5 / 245 | 4 / 252 |
Outcome results
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.
Time frame: Within 2 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tamsulosin | Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention | 23 Participants |
| Placebo | Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention | 25 Participants |
p-value: 0.96Chi-squared, Corrected
Secondary
Length of Stay
Length of hospital stay
Time frame: 0-7 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin | Length of Stay | 0.9 days | Standard Deviation 1.2 |
| Placebo | Length of Stay | 0.7 days | Standard Deviation 0.9 |
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?
Time frame: Within 2 days after surgery
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tamsulosin | Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual | Postoperative urinary retention | 18 Participants |
| Tamsulosin | Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual | No postoperative urinary retention | 273 Participants |
| Placebo | Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual | Postoperative urinary retention | 22 Participants |
| Placebo | Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual | No postoperative urinary retention | 134 Participants |