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

Postoperative Urinary Retention Clinical Trial

Official title:

Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Tamsulosin for Postoperative Urinary Retention in Primary Total Hip and Knee Arthroplasty Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02518971
• Other study ID #: HUM00087825
• Status: Terminated
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: December 19, 2018

Study information

• Verified date: March 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 176
• Est. completion date: December 19, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Urinary Retention
• Urinary Retention

Intervention

Drug:
• Tamsulosin
0.4 mg daily
• Placebo
one capsule daily

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients to Develop Postoperative Urinary Retention (POUR)	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.	Postop day 1
Secondary	Length of Hospital Stay	Length of hospital stay will be recorded in days and compared statistically between the two groups .	1-4 days postoperative
Secondary	Incidence of Discharge to a Skilled Nursing Facility	Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.	1-4 days postoperative
Secondary	Incidence of Surgical Site Infection	Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.	Up to two weeks postoperative
Secondary	Acute Postoperative Pain Medication Dosages	The dosages of postoperative pain medications will be compared statistically between the two groups.	Postoperative day 1 to day of discharge (1-4 days on average)
Secondary	Incidence of Postoperative Complications	Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.	Up to 31 days postoperative