Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients

• Sponsor: University of Michigan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02518971
• Collaborator: (none)
• Enrollment: 176
• Location: 1
• Arms: 2
• Actual Duration (Months): 40.6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

The study aims to evaluate the efficacy of prophylactic tamsulosin in reducing the incidence of postoperative urinary retention in primary total knee and hip arthroplasty patients.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Urinary Retention	Drug: Tamsulosin; Drug: Placebo	Phase 3

Detailed Description

Prophylactic administration of tamsulosin will be compared to a placebo to evaluate the effectiveness in reducing the incidence of postoperative urinary retention in total hip and knee arthroplasty patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Jun 5, 2018
• Actual Study Completion Date: Dec 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tamsulosin 0.4 mg daily for five days pre-op through post-op day one (seven total)	Drug: Tamsulosin; 0.4 mg daily; Other Names: Flomax
Placebo Comparator: placebo One capsule daily for five days pre-op through post-op day one (seven total)	Drug: Placebo; one capsule daily

Outcome Measures

Primary Outcome Measures

1. Number of Patients to Develop Postoperative Urinary Retention (POUR) [Postop day 1]

   Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.

Secondary Outcome Measures

1. Length of Hospital Stay [1-4 days postoperative]

   Length of hospital stay will be recorded in days and compared statistically between the two groups .

2. Incidence of Discharge to a Skilled Nursing Facility [1-4 days postoperative]

   Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.

3. Incidence of Surgical Site Infection [Up to two weeks postoperative]

   Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.

4. Acute Postoperative Pain Medication Dosages [Postoperative day 1 to day of discharge (1-4 days on average)]

   The dosages of postoperative pain medications will be compared statistically between the two groups.

5. Incidence of Postoperative Complications [Up to 31 days postoperative]

   Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men age 35 or older

• Primary total hip and knee arthroplasty patients (general, spinal, or epidural anesthesia

• No current use (>1 month) of alpha-blockers

• Community ambulator

• Adequate organ and marrow function as defined below:

leucocytes at least 3,000/µL, absolute neutrophil count at least 1,500/µL, platelets at least 100,000/µL, creatinine within normal institutional limits

• Ability to understand, and the willingness to sign, a written informed consent

Exclusion Criteria:

• History of radical prostatectomy

• Receiving any other investigational agents

• Revision hip and knee arthroplasty patients

• Severe liver or kidney disease

• Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)

• Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin)

• Being of 5-alpha reductase inhibitors (finasteride, dutasteride)

• History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Taking Sildenafil,Tadalafil, or Vardenafil

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Health System	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Andrew Urquhart, MD, University of Michigan, Dept of Orthopaedic Surgery
• Study Director: Manuel Schubert, MD, University of Michigan, Dept of Orthopaedic Surgery

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 8, 2018

More Information

Publications

None provided.

• Responsible Party: Andrew Urquhart, Associate Professor of Orthopaedic Surgery, University of Michigan
• ClinicalTrials.gov Identifier: NCT02518971
• Other Study ID Numbers: HUM00087825
• First Posted: Aug 10, 2015
• Last Update Posted: Apr 12, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urinary Retention; Tamsulosin

Study Results

Participant Flow

Pre-assignment Detail	176 subjects were enrolled in the study. 174 were randomized to either the active tamsulosin group or placebo group and 2 subjects were withdrawn prior to randomization. 43 additional patients were withdrawn after randomization.

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily	One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily
Period Title: Overall Study
STARTED	87	87
COMPLETED	64	67
NOT COMPLETED	23	20

Baseline Characteristics

Arm/Group Title	Tamsulosin	Placebo	Total
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily	One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily	Total of all reporting groups
Overall Participants	64	67	131
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.55 (10.4)	61.37 (9.6)	60.98 (9.96)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	64 100%	67 100%	131 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Patients to Develop Postoperative Urinary Retention (POUR)
Description	Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.
Time Frame	Postop day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily	One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily
Measure Participants	64	67
Count of Participants [Participants]	18 28.1%	24 35.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamsulosin, Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.345
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Length of Hospital Stay
Description	Length of hospital stay will be recorded in days and compared statistically between the two groups .
Time Frame	1-4 days postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily	One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily
Measure Participants	64	67
Mean (Standard Deviation) [days]	1.125 (0.42)	1.209 (0.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamsulosin, Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.378
	Comments
	Method	Student T-Test
	Comments

3. Secondary Outcome

Title	Incidence of Discharge to a Skilled Nursing Facility
Description	Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.
Time Frame	1-4 days postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily	One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily
Measure Participants	64	67
Count of Participants [Participants]	1 1.6%	1 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamsulosin, Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	Incidence of Surgical Site Infection
Description	Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.
Time Frame	Up to two weeks postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily	One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily
Measure Participants	64	64
Count of Participants [Participants]	0 0%	2 3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamsulosin, Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.497
	Comments
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	Acute Postoperative Pain Medication Dosages
Description	The dosages of postoperative pain medications will be compared statistically between the two groups.
Time Frame	Postoperative day 1 to day of discharge (1-4 days on average)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily	One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily
Measure Participants	64	67
Mean (Standard Deviation) [morphine equivalent doses]	44.85 (47.18)	36 (31.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamsulosin, Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.207
	Comments
	Method	Student T-test
	Comments

6. Secondary Outcome

Title	Incidence of Postoperative Complications
Description	Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.
Time Frame	Up to 31 days postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tamsulosin	Placebo
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily	One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily
Measure Participants	64	67
Count of Participants [Participants]	2 3.1%	2 3%

Adverse Events

Time Frame	31 days post-operatively
Arm/Group Title	Tamsulosin		Placebo		Not Randomized
Arm/Group Description	0.4 mg daily for five days pre-op through post-op day one (seven total) Tamsulosin: 0.4 mg daily		One capsule daily for five days pre-op through post-op day one (seven total) Placebo: one capsule daily		Participants were withdrawn from study before randomization
All Cause Mortality
	Tamsulosin		Placebo		Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/67 (0%)		0/2 (0%)
Serious Adverse Events
	Tamsulosin		Placebo		Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/64 (3.1%)		0/67 (0%)		0/2 (0%)
Eye disorders
Floppy Iris Syndrome	2/64 (3.1%)	2	0/67 (0%)	0	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	Tamsulosin		Placebo		Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/64 (31.3%)		11/67 (16.4%)		0/2 (0%)
Cardiac disorders
hypotension	0/64 (0%)	0	2/67 (3%)	2	0/2 (0%)	0
Gastrointestinal disorders
constipation	2/64 (3.1%)	2	1/67 (1.5%)	1	0/2 (0%)	0
GI Bleed	1/64 (1.6%)	1	0/67 (0%)	0	0/2 (0%)	0
General disorders
Dizziness	1/64 (1.6%)	1	2/67 (3%)	2	0/2 (0%)	0
Syncope	3/64 (4.7%)	3	0/67 (0%)	0	0/2 (0%)	0
Fatigue	1/64 (1.6%)	1	0/67 (0%)	0	0/2 (0%)	0
Immune system disorders
Hives/pruritus	1/64 (1.6%)	1	0/67 (0%)	0	0/2 (0%)	0
Infections and infestations
Surgical Site Infection	0/64 (0%)	0	2/67 (3%)	2	0/2 (0%)	0
Viral Infection	1/64 (1.6%)	1	0/67 (0%)	0	0/2 (0%)	0
Urinary Tract Infection	2/64 (3.1%)	2	0/67 (0%)	0	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Calf Pain	3/64 (4.7%)	3	0/67 (0%)	0	0/2 (0%)	0
Gout Flare	0/64 (0%)	0	1/67 (1.5%)	1	0/2 (0%)	0
Nervous system disorders
Altered Mental Status	1/64 (1.6%)	1	0/67 (0%)	0	0/2 (0%)	0
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	1/64 (1.6%)	1	0/67 (0%)	0	0/2 (0%)	0
Skin and subcutaneous tissue disorders
delayed wound healing/wound dehiscence	0/64 (0%)	0	1/67 (1.5%)	1	0/2 (0%)	0
Surgical and medical procedures
increased post operative pain	5/64 (7.8%)	5	2/67 (3%)	2	0/2 (0%)	0

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.