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Alpha-1 Adrenergic Receptor Antagonist
Preoperative Tamsulosin for Postoperative Urinary Retention
Phase 3
Recruiting
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mid-urethral sling placement
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up chart review of 30 days postoperative after surgery
Awards & highlights
Study Summary
This trial is testing if a single dose of preoperative tamsulosin can reduce post-op urinary retention, which 25-30% of patients experience after female pelvic surgery. If successful, this would improve patient outcomes and satisfaction postoperatively.
Who is the study for?
This trial is for patients undergoing mid-urethral sling placement to treat urinary issues. It's not for those under 18, having additional colorectal, general surgery or gynecology-oncology procedures, with a history of slings or urinary retention, receiving bladder botox injections, or who can't take tamsulosin.Check my eligibility
What is being tested?
The study tests if taking a single dose of Tamsulosin before surgery can reduce postoperative urinary retention compared to a placebo. This could potentially eliminate the need for patients to go home with a catheter after pelvic surgeries.See study design
What are the potential side effects?
Tamsulosin may cause dizziness, headache, sleepiness, nausea and low blood pressure. Since it's given preoperatively in this trial, side effects are monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a mid-urethral sling procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ chart review of 30 days postoperative after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~chart review of 30 days postoperative after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative urinary retention
Secondary outcome measures
Postoperative UTI
Postoperative hypotension
Postoperative pain
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TamsulosinExperimental Treatment1 Intervention
Subjects randomized to the experimental arm will receive a single dose of 0.4mg Tamsulosin tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.
Group II: PlaceboPlacebo Group1 Intervention
Subjects randomized to the control arm will receive a single dose of a placebo tablet in the preoperative holding area prior to their scheduled mid-urethral sling placement in the operating room.
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?
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,498 Total Patients Enrolled
2 Trials studying Urinary Retention
77 Patients Enrolled for Urinary Retention
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of not being able to empty my bladder completely.I am receiving bladder injections with Botox.I have had or am planning to have surgery to adjust or place a sling.I am under 18 years old.I am scheduled for surgery that involves colorectal, general, or gynecologic-oncology procedures.I cannot take tamsulosin due to health reasons.I have had a mid-urethral sling procedure.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical trial currently enrolling participants?
"As the records on clinicaltrials.gov demonstrate, this medical investigation is not currently accepting participants. The trial was launched on July 1st 2023 and last updated February 27th 2023. However, there are 34 other trials that need volunteers right now."
Answered by AI
Is Tamsulosin a secure option for individuals?
"Our team rates Tamsulosin's safety as a 3 due to the existing clinical evidence, which suggests that its efficacy is well-documented and has been tested thoroughly for potential risks."
Answered by AI
Is this research endeavor seeking elderly individuals as participants?
"This clinical trial is open to patients aged between 18 and 99, but there are additional trials for minors and seniors. Specifically, 1 study caters to participants under the age of 18 while 32 specialise in elderly care."
Answered by AI
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