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Tamsulosin for Postoperative Urinary Retention
Phase < 1
Recruiting
Led By Thomas Bauer, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned thoracic oncological surgical procedure of a video assisted oncological surgical procedure for suspected or confirmed cancer.
Males ≥55 years old
Must not have
Current use of Boceprevir
Known diagnosis of congestive heart failure (CHF) and valvular heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-8 hours post operative
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if Tamsulosin can reduce the risk of post-surgery urinary retention in older men with cancer surgery. It will also look at how quickly normal urinary function returns.
Who is the study for?
This trial is for men aged 55 or older who are scheduled to have thoracic cancer surgery and haven't used Tamsulosin before. They shouldn't have low blood pressure, a history of heart failure, valvular heart disease, or previous prostate surgery.
What is being tested?
The study tests if Tamsulosin can reduce the high rates of urinary retention after thoracic cancer surgery in older men and how quickly it helps resume normal urinary function post-surgery.
What are the potential side effects?
Tamsulosin may cause dizziness, especially when standing up from sitting or lying down (orthostatic hypotension), allergies in those sensitive to sulfa drugs, and could interact with certain medications like Boceprevir.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a minimally invasive chest cancer surgery.
Select...
I am a man aged 55 or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking Boceprevir.
Select...
I have been diagnosed with congestive heart failure and heart valve disease.
Select...
I have a history of low blood pressure.
Select...
I have had surgery on my prostate before.
Select...
I am currently taking Tamsulosin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-8 hours post operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-8 hours post operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amount of residual urine
Number of participants that needed an intervention due to failure to spontaneously urinate
Number of participants that were able to spontaneously void after surgery completion
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pre-operative Tamsulosin administrationExperimental Treatment1 Intervention
Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery for thoracic cancer. Tamsulosin dose is set at 0.4mg/day and should be taken daily for seven days prior to their planned surgery date. Study subjects will also be given a diary to record their daily usage. Study subjects should take Tamsulosin on the day of the surgery with a sip of water.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamsulosin
2002
Completed Phase 4
~16790
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
135 Previous Clinical Trials
30,276 Total Patients Enrolled
1 Trials studying Urinary Retention
127 Patients Enrolled for Urinary Retention
Thomas Bauer, MDPrincipal InvestigatorHackensack Meridian Health
1 Previous Clinical Trials
128 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to Tamsulosin or sulfa drugs.I am scheduled for a minimally invasive chest cancer surgery.I am currently taking Boceprevir.Your blood pressure drops significantly when you stand up from sitting, as measured after standing for 2 minutes.I have been diagnosed with congestive heart failure and heart valve disease.I have a history of low blood pressure.I have had surgery on my prostate before.I am currently taking Tamsulosin.My surgery is scheduled for more than a week after I give consent.Your blood pressure when you are not active is less than 100.I am a man aged 55 or older.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-operative Tamsulosin administration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.