Trial Outcomes & Findings for Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery (NCT NCT02919436)

NCT ID: NCT02919436

Last Updated: 2022-02-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

610 participants

Primary outcome timeframe

Within 2 days after surgery

Results posted on

2022-02-17

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	305	305
Overall Study COMPLETED	245	252
Overall Study NOT COMPLETED	60	53

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Did not undergo surgery	16	20
Overall Study Enrolled before trial registration	44	33

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tamsulosin n=245 Participants 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	Placebo n=252 Participants 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	Total n=497 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 7.7 • n=245 Participants	63.7 years STANDARD_DEVIATION 8.7 • n=252 Participants	63.5 years STANDARD_DEVIATION 8.1 • n=497 Participants
Sex: Female, Male Female	0 Participants n=245 Participants	0 Participants n=252 Participants	0 Participants n=497 Participants
Sex: Female, Male Male	245 Participants n=245 Participants	252 Participants n=252 Participants	497 Participants n=497 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
History of hypertension	165 Participants n=245 Participants	163 Participants n=252 Participants	328 Participants n=497 Participants
History of insulin-dependent diabetes mellitus	21 Participants n=245 Participants	19 Participants n=252 Participants	40 Participants n=497 Participants
History of non-insulin dependent diabetes mellitus	59 Participants n=245 Participants	49 Participants n=252 Participants	108 Participants n=497 Participants
History of benign prostatic hyperplasia	15 Participants n=245 Participants	23 Participants n=252 Participants	38 Participants n=497 Participants
Current opioid use	55 Participants n=245 Participants	52 Participants n=252 Participants	107 Participants n=497 Participants
Current smoker	48 Participants n=245 Participants	36 Participants n=252 Participants	84 Participants n=497 Participants
Body mass index > 30	130 Participants n=245 Participants	136 Participants n=252 Participants	266 Participants n=497 Participants
BMI mean	30.9 kg/m^2 STANDARD_DEVIATION 5.7 • n=245 Participants	31.1 kg/m^2 STANDARD_DEVIATION 5.6 • n=252 Participants	31.1 kg/m^2 STANDARD_DEVIATION 5.6 • n=497 Participants
Office post-void residual < 50 cc	141 Participants n=245 Participants	150 Participants n=252 Participants	291 Participants n=497 Participants
Modified International Prostate Symptom Score mean	5.1 Scores on a scale STANDARD_DEVIATION 4.6 • n=245 Participants	4.9 Scores on a scale STANDARD_DEVIATION 4.2 • n=252 Participants	5.0 Scores on a scale STANDARD_DEVIATION 4.4 • n=497 Participants
Lumbar spine surgery	175 Participants n=245 Participants	199 Participants n=252 Participants	374 Participants n=497 Participants
Arthrodesis performed	66 Participants n=245 Participants	62 Participants n=252 Participants	128 Participants n=497 Participants

PRIMARY outcome

Timeframe: Within 2 days after surgery

Outcome measures

Outcome measures
Measure	Tamsulosin n=245 Participants 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	Placebo n=252 Participants 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
Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention	23 Participants	25 Participants

SECONDARY outcome

Timeframe: 0-7 days after surgery

Length of hospital stay

Outcome measures

Outcome measures
Measure	Tamsulosin n=245 Participants 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	Placebo n=252 Participants 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
Length of Stay	0.9 days Standard Deviation 1.2	0.7 days Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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.

Was post-void residual greater than 50 cc when measured at the preoperative office visit associated with postoperative urinary retention?

Outcome measures

Outcome measures
Measure	Tamsulosin n=291 Participants 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	Placebo n=156 Participants 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
Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual Postoperative urinary retention	18 Participants	22 Participants
Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual No postoperative urinary retention	273 Participants	134 Participants

Adverse Events

Tamsulosin

Serious events: 5 serious events

Other events: 25 other events

Deaths: 1 deaths

Placebo

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tamsulosin n=245 participants at risk 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	Placebo n=252 participants at risk 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
Gastrointestinal disorders Ileus	0.41% 1/245 • Number of events 1 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	0.00% 0/252 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
Infections and infestations Infection	0.82% 2/245 • Number of events 2 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	0.40% 1/252 • Number of events 1 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
Surgical and medical procedures Postop neurosurgical complication	0.41% 1/245 • Number of events 1 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	0.40% 1/252 • Number of events 1 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
Cardiac disorders Myocardial infarction	0.41% 1/245 • Number of events 1 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	0.00% 0/252 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
General disorders Other	0.00% 0/245 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	0.79% 2/252 • Number of events 2 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.

Other adverse events

Other adverse events
Measure	Tamsulosin n=245 participants at risk 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	Placebo n=252 participants at risk 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
Renal and urinary disorders Urinary issues	2.9% 7/245 • Number of events 7 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	3.2% 8/252 • Number of events 8 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
Gastrointestinal disorders Nausea / emesis	2.0% 5/245 • Number of events 5 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	0.40% 1/252 • Number of events 1 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
General disorders Headache	1.2% 3/245 • Number of events 3 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	0.00% 0/252 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
Cardiac disorders Cardiac	0.41% 1/245 • Number of events 1 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	0.40% 1/252 • Number of events 1 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
General disorders Other	3.7% 9/245 • Number of events 9 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.	2.0% 5/252 • Number of events 5 • Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.

Additional Information

Dr. Anand Rughani

Maine Medical Center

Phone: 207-885-0011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place