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Tamsulosin for Urinary Retention
Study 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.
- Postoperative Urinary Retention
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Tamsulosin
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
Has Tamsulosin hydrochloride undergone drug trials by the FDA?
"Tamsulosin hydrochloride is estimated to be a safe drug, as it has reached Phase 3 in clinical trials. This means that there is some data supporting its efficacy and multiple rounds of data supporting safety."
Are there any current openings for patients who wish to enroll in this clinical trial?
"That is correct, the listed information on clinicaltrials.gov does specify that this study is recruiting patients. The posting date was May 1st 2012 with the most recent update being February 18th 2022. They are looking for 350 participants at a single site."
What do doctors use Tamsulosin hydrochloride to manage most frequently?
"Tamsulosin hydrochloride is an effective medical intervention for bladder outlet obstruction, ureteral calculus, and benign prostatic hyperplasia (bph)."
How many people total are included in this research project?
"That is accurate. The clinicaltrials.gov website shows that this research is currently recruiting participants. This study was first advertised on May 1st, 2012 and received its latest update February 18th, 2022. A total of 350 individuals are needed at a single location."
What other research exists on Tamsulosin hydrochloride?
"Presently, there are 3 Phase 3 trials and 15 active investigations in total for Tamsulosin hydrochloride. Most of these studies originate from Baden, Aargau; however, research is being conducted at 15 locations worldwide."
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