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Neurotoxin
Low-Dose Botox for Urinary Incontinence (RELIEF Trial)
Phase 1 & 2
Recruiting
Led By Anne C Cooper, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult female at least 70 years old at date of enrollment
On average 2 or more urgency or insensible incontinence episodes per day per patient report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, & 12 months post injection. results will be compared at the end of the 12 months.
Awards & highlights
RELIEF Trial Summary
This trial will study a lower dose of Botox to treat urinary incontinence in women over 70.
Who is the study for?
This trial is for women aged 70 or older with urgency urinary incontinence who've tried other treatments without success. They should be able to handle catheterization if needed, have no major neurological issues affecting bladder function, and not be using certain medications or therapies that could interfere with the study.Check my eligibility
What is being tested?
The study compares two doses of Botox injections (50 units vs. 100 units) in treating urinary urgency among elderly females. It aims to determine whether a reduced dose can effectively manage symptoms while potentially minimizing side effects.See study design
What are the potential side effects?
Possible side effects include difficulty emptying the bladder requiring temporary catheterization, urinary tract infections, discomfort at the injection site, and allergic reactions to components like lidocaine or Botox itself.
RELIEF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 70 or older.
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I experience 2 or more sudden urges to urinate or involuntary urine leaks daily.
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I am not using sacral neuromodulation therapy.
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My severe urge to urinate hasn't improved despite trying medications or other treatments.
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My nervous system functions normally and does not affect my bladder control.
RELIEF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3, 6, & 12 months post injection. results will be compared at the end of the 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, & 12 months post injection. results will be compared at the end of the 12 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in symptom specific quality of life and bother over time.
Secondary outcome measures
Change in Global Symptom Improvement
Change in general health-related quality of life as measure by the Health Utility Index-3
Change in number of urgency urinary incontinence (UUI) episodes per day.
+7 moreRELIEF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Botox: Low doseExperimental Treatment1 Intervention
A lower dose of 50 units of botox will be injected into the bladder.
Group II: Botox: Standard doseActive Control1 Intervention
The standard dose of 100 units of botox will be injected into the bladder.
Find a Location
Who is running the clinical trial?
Dartmouth CollegeOTHER
83 Previous Clinical Trials
1,415,419 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,594 Previous Clinical Trials
2,282,103 Total Patients Enrolled
University of PittsburghOTHER
1,732 Previous Clinical Trials
16,306,796 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to have surgery for prolapse or incontinence but can join the trial 3 months after.You are allergic or can't tolerate lidocaine or BTX.I am a woman aged 70 or older.I experience 2 or more sudden urges to urinate or involuntary urine leaks daily.My pelvic floor prolapse is severe and hasn't improved with a pessary.I am not taking anticholinergic or beta-3 agonist medications, or I can stop them for 3 weeks.I am not using sacral neuromodulation therapy.My severe urge to urinate hasn't improved despite trying medications or other treatments.My nervous system functions normally and does not affect my bladder control.You have more problems with sudden urges to urinate than with leaking when you cough or sneeze, according to the MESA questionnaire.I am unable to understand and give consent for treatment.I need my Botox injections to be done in an Operating Room or while I'm sedated.My bladder doesn't work properly due to a nerve problem.I have used more than 300 units of Botox for another condition in the last 3 months.You have had consistently high levels of urine left in your bladder after using the restroom.I haven't had bladder Botox or sacral nerve therapy in the last year.I currently have a urinary tract infection that hasn't been treated.I have a history of bladder issues, including cancer or severe inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Botox: Standard dose
- Group 2: Botox: Low dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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