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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
Must not have
Fecal incontinence, and symptomatic colitis/IBS
History of pelvic radiation or advanced uterine/bladder cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 to 24 weeks
Awards & highlights
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have bowel control issues and symptoms of colitis or IBS.
Select...
I have had radiation in my pelvic area or have advanced cancer in my uterus or bladder.
Select...
I have previously been treated for urinary incontinence with Botox or nerve stimulation.
Select...
I have a blockage in my urethra causing poor urine flow.
Select...
I need IV antibiotics to prevent infections.
Select...
I have a spinal cord injury.
Select...
I am not planning to change my medications during the study.
Select...
My condition involves tissue bulging out beyond the vaginal opening.
Select...
I am not taking any medications or have conditions that conflict with trospium.
Select...
I have been diagnosed with interstitial cystitis.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
~2430
Find a Location
Who is running the clinical trial?
Becky ClarksonLead Sponsor
Neil M. ResnickLead Sponsor
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,783 Total Patients Enrolled
13 Trials studying Urinary Incontinence
2,420 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.
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