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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02518971
Other study ID # HUM00087825
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT02958878 - Preoperative Administration of Tamsulosin for Prevention of Post Operative Urinary Retention in Males Undergoing Elective Inguinal Hernia Repair Phase 4
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