DRIPS: Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery

• Sponsor: Anand Rughani, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02919436
• Collaborator: MaineHealth (Other)
• Enrollment: 610
• Location: 1
• Arms: 2
• Duration (Months): 56
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Urinary Retention	Drug: Tamsulosin; Drug: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 610 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tamsulosin Subjects in this arm will receive tamsulosin 0.4 mg/day for five days prior to surgery and two days after surgery.	Drug: Tamsulosin; Active drug; Other Names: Flomax Flomaxtra Contiflo XL Urimax
Placebo Comparator: 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.	Drug: Placebo; Lactose-filled capsules identical to active drug

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Length of Stay [0-7 days after surgery]

   Length of hospital stay

2. 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?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maine Medical Center	Portland	Maine	United States	04102

Sponsors and Collaborators

• Anand Rughani, MD
• MaineHealth

Investigators

• Principal Investigator: Anand Rughani, MD, MaineHealth

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 3, 2019

More Information

Publications

None provided.

• Responsible Party: Anand Rughani, MD, Neurosurgeon, MaineHealth
• ClinicalTrials.gov Identifier: NCT02919436
• Other Study ID Numbers: IRB #4742
• First Posted: Sep 29, 2016
• Last Update Posted: Feb 17, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Urinary Retention; Tamsulosin

Study Results

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 Detail	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).

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	305	305
COMPLETED	245	252
NOT COMPLETED	60	53

Baseline Characteristics

Arm/Group Title	Tamsulosin	Placebo	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	245	252	497
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.4 (7.7)	63.7 (8.7)	63.5 (8.1)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	245 100%	252 100%	497 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
History of hypertension (Count of Participants)
Count of Participants [Participants]	165 67.3%	163 64.7%	328 66%
History of insulin-dependent diabetes mellitus (Count of Participants)
Count of Participants [Participants]	21 8.6%	19 7.5%	40 8%
History of non-insulin dependent diabetes mellitus (Count of Participants)
Count of Participants [Participants]	59 24.1%	49 19.4%	108 21.7%
History of benign prostatic hyperplasia (Count of Participants)
Count of Participants [Participants]	15 6.1%	23 9.1%	38 7.6%
Current opioid use (Count of Participants)
Count of Participants [Participants]	55 22.4%	52 20.6%	107 21.5%
Current smoker (Count of Participants)
Count of Participants [Participants]	48 19.6%	36 14.3%	84 16.9%
Body mass index > 30 (Count of Participants)
Count of Participants [Participants]	130 53.1%	136 54%	266 53.5%
BMI mean (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.9 (5.7)	31.1 (5.6)	31.1 (5.6)
Office post-void residual < 50 cc (Count of Participants)
Count of Participants [Participants]	141 57.6%	150 59.5%	291 58.6%
Modified International Prostate Symptom Score mean (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	5.1 (4.6)	4.9 (4.2)	5.0 (4.4)
Lumbar spine surgery (Count of Participants)
Count of Participants [Participants]	175 71.4%	199 79%	374 75.3%
Arthrodesis performed (Count of Participants)
Count of Participants [Participants]	66 26.9%	62 24.6%	128 25.8%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Who Undergo Postoperative Catheterization for Urinary Retention
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	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	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
Measure Participants	245	252
Count of Participants [Participants]	23 9.4%	25 9.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamsulosin, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments	We found observed rate of postoperative urinary retention in male spine surgery patients to historically be 17%. We hypothesize that the use of tamsulosin can reduce this rate by 50%. A two group continuity corrected chi-square test with a .05 two-sided significance level will have 80% power to detect the difference between a control group proportion of .17 and a treatment group proportion of .085 (odds ratio of .454) when the sample size in each group is 264 and a total sample size of 528.
Statistical Test of Hypothesis	p-Value	.96
	Comments
	Method	Chi-squared, Corrected
	Comments

2. Secondary Outcome

Title	Length of Stay
Description	Length of hospital stay
Time Frame	0-7 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	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	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
Measure Participants	245	252
Mean (Standard Deviation) [days]	0.9 (1.2)	0.7 (0.9)

3. Secondary Outcome

Title	Number of Participants With or Without Postoperative Urinary Retention Based on Preoperative Post-void Residual
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Preoperative Post-void Residual < 50 cc	Preoperative Post-void Residual >/= 50 cc
Arm/Group Description	Subjects in this group had a post-void residual greater than 50 cc in the preoperative office visit	Subjects in this group had a post-void residual greater than or equal to 50 cc in the preoperative office visit
Measure Participants	291	156
Postoperative urinary retention	18 7.3%	22 8.7%
No postoperative urinary retention	273 111.4%	134 53.2%

Adverse Events

Time Frame	Adverse event data were collected for 2 weeks following each subject's discharge from the hospital.
Arm/Group Title	Tamsulosin		Placebo
Arm/Group Description	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		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
All Cause Mortality
	Tamsulosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/245 (0.4%)		0/252 (0%)
Serious Adverse Events
	Tamsulosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/245 (2%)		4/252 (1.6%)
Cardiac disorders
Myocardial infarction	1/245 (0.4%)	1	0/252 (0%)	0
Gastrointestinal disorders
Ileus	1/245 (0.4%)	1	0/252 (0%)	0
General disorders
Other	0/245 (0%)	0	2/252 (0.8%)	2
Infections and infestations
Infection	2/245 (0.8%)	2	1/252 (0.4%)	1
Surgical and medical procedures
Postop neurosurgical complication	1/245 (0.4%)	1	1/252 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Tamsulosin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/245 (10.2%)		15/252 (6%)
Cardiac disorders
Cardiac	1/245 (0.4%)	1	1/252 (0.4%)	1
Gastrointestinal disorders
Nausea / emesis	5/245 (2%)	5	1/252 (0.4%)	1
General disorders
Headache	3/245 (1.2%)	3	0/252 (0%)	0
Other	9/245 (3.7%)	9	5/252 (2%)	5
Renal and urinary disorders
Urinary issues	7/245 (2.9%)	7	8/252 (3.2%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.