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Alpha-1 Adrenergic Receptor Antagonist
Tamsulosin for Urinary Retention
Phase 3
Waitlist Available
Led By Michelle Clarke, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants will be followed for the duration of the hospital stay, an expected average of 5 days
Awards & highlights
Pivotal Trial
Summary
This trial is testing if a drug called Tamsulosin can reduce postoperative urinary retention and related morbidity for people who have had spinal surgery.
Eligible Conditions
- Postoperative Urinary Retention
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants will be followed for the duration of the hospital stay, an expected average of 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants will be followed for the duration of the hospital stay, an expected average of 5 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Postoperative Urinary Retention
Secondary study objectives
Duration of Postoperative Urinary Retention
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TamsulosinExperimental Treatment1 Intervention
Participants randomized to this arm will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to this arm will receive a daily placebo capsule matching the active study drug from 5 days prior to the operation until hospital discharge.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamsulosin hydrochloride
1998
Completed Phase 4
~1140
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,349 Previous Clinical Trials
3,061,006 Total Patients Enrolled
Michelle Clarke, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion refers to a specific type of surgery for a herniated disc in the lower back, either done with a METRx procedure or through an open surgery.You have a serious liver disease or very advanced kidney disease.You have a mental disability.This criterion refers to a specific type of spinal surgery called lumbar posterolateral fusion.You are younger than 35 years old.You have had surgery to remove the prostate or any surgery involving the bladder or urethra.You have had surgery to remove and fuse together discs in your neck.This criterion refers to a surgical procedure to remove a portion of the cervical spine.Criterion: Surgery to remove part of a herniated disc in the neck.Criterion: Cervical foraminotomy.Criterion: Lumbar foraminotomy.You are currently taking a medication called an alpha-antagonist.You have had an allergic reaction to tamsulosin or other similar medications used to treat certain health conditions.You are taking certain strong medications that can interact with the study drug.You are 35 years old or older, regardless of gender.Criterion: You have had a procedure called cervical posterior fusion.You have had fusion surgery in your neck.This criterion refers to a specific type of back surgery called a lumbar laminectomy.Criterion: Having a lumbar interbody fusion procedure.Previous surgery to fuse the bones in the lower back.You have a spine condition that affects how your bladder works.
Research Study Groups:
This trial has the following groups:- Group 1: Tamsulosin
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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