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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.
Select...
I am not using sacral neuromodulation therapy.
Select...
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
81 Previous Clinical Trials
1,415,314 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,590 Previous Clinical Trials
2,281,286 Total Patients Enrolled
University of PittsburghOTHER
1,723 Previous Clinical Trials
16,342,780 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for volunteers to join this trial?
"As indicated by the clinicaltrials.gov listing, this medical research is actively seeking participants for enrolment. The original call for volunteers was published on May 1st 2023 and it has since been amended as recently as 11th of May 2023."
Answered by AI
Are there numerous locales hosting this study in North America?
"Currently, the research is being conducted at Kaiser Permanente Medical Group in San Diego, Dartmouth-Hitchcock Medical Center in Lebanon and Oregon Health & Science University in Portland as well as 6 other sites."
Answered by AI
What is the current sample size of participants in this experiment?
"Affirmative. According to the details hosted on clinicaltrials.gov, this medical trial posted on May 1st 2023 is currently admitting participants and was last updated on 11th of same month. Ultimately, 376 people need to be enrolled from 6 distinct research centres for this experiment to continue."
Answered by AI
Who else is applying?
What site did they apply to?
University of Alabama - Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I have severe incontinence issues due to spinal injury and sensory trouble.
PatientReceived 1 prior treatment
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