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Muscarinic Antagonist
Trospium for Urinary Incontinence
Phase 4
Recruiting
Led By Becky Clarkson, PhD
Research Sponsored by Becky Clarkson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has UUI or urge-predominant mixed incontinence at least 5 times/ week for > 3 months despite treatment for reversible causes
60+ years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 to 24 weeks
Awards & highlights
Study Summary
This trial is testing whether trospium, a drug used to treat urinary incontinence, can also help improve brain function in relation to bladder control.
Who is the study for?
This trial is for women over 60 with urgency urinary incontinence (UUI) or urge-predominant mixed incontinence, occurring at least five times a week for more than three months despite treatment. Participants must not have certain medical conditions like spinal cord injury, severe pelvic issues, or be on conflicting medications.Check my eligibility
What is being tested?
The study tests the effectiveness of Trospium against a placebo in managing UUI symptoms and examines how the brain responds to these treatments using MRI scans. It's a randomized double-blind crossover trial, meaning participants will receive both the drug and placebo at different times without knowing which one they're taking.See study design
What are the potential side effects?
While specific side effects are not listed here, Trospium can typically cause dry mouth, constipation, blurred vision and dizziness. Placebos generally do not cause side effects but any unexpected reactions could occur due to the body's response to taking tablets.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had frequent urges to urinate or accidents for more than 3 months, despite treatment.
Select...
I am 60 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional brain changes
Structural brain changes
Trial Design
2Treatment groups
Experimental Treatment
Group I: Trospium/PlaceboExperimental Treatment2 Interventions
Trospium first for 12 weeks followed by Placebo for 12 weeks
Group II: Placebo/TrospiumExperimental Treatment2 Interventions
Placebo first for 12 weeks followed by Trospium for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo oral tablet
2019
Completed Phase 4
~2450
Find a Location
Who is running the clinical trial?
Becky ClarksonLead Sponsor
Neil M. ResnickLead Sponsor
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,665 Total Patients Enrolled
13 Trials studying Urinary Incontinence
2,480 Patients Enrolled for Urinary Incontinence
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have bowel control issues and symptoms of colitis or IBS.I have had radiation in my pelvic area or have advanced cancer in my uterus or bladder.I have previously been treated for urinary incontinence with Botox or nerve stimulation.You cannot have an MRI for medical reasons.I have a blockage in my urethra causing poor urine flow.I need IV antibiotics to prevent infections.I haven't started a new incontinence treatment in the last 3 months.I have had frequent urges to urinate or accidents for more than 3 months, despite treatment.I have a spinal cord injury.I am not planning to change my medications during the study.My condition involves tissue bulging out beyond the vaginal opening.I am 60 years old or older.I am not taking any medications or have conditions that conflict with trospium.I have been diagnosed with interstitial cystitis.I have stopped taking anticholinergic medications for 4 weeks.My mobility or thinking ability does not prevent me from following study procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo/Trospium
- Group 2: Trospium/Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
How many people will be included in this experiment at most?
"The most recent data from clinicaltrials.gov indicates that this trial is still actively looking for participants. The study, which was originally posted on February 13th 2020, needs to recruit an additional 220 patients from 1 location."
Answered by AI
Are there any harmful side effects associated with taking Trospium?
"Trospium is a safe medication, as evidenced by its Phase 4 clinical trial status."
Answered by AI
Are there any other ongoing or completed research studies that use Trospium?
"Currently, there are 5 clinical trials underway for Trospium. Of these, 4 are in Phase 3. Although the great majority of these studies are based in Riverside, California - 159 total locations across the USA are conducting trials for this medication."
Answered by AI
Are participants still being accepted for this clinical trial?
"Yes, this is an ongoing study that published their recruitment information on clinicaltrials.gov. The listing says they are enrolling 220 patients at 1 location, and the trial dates listed are 2/13/2020-6/30/2022."
Answered by AI
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