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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

Must not have

Greater than stage 2 pelvic floor prolapse, uncorrected or persistent despite pessary use

Lack of capacity to provide consent

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My pelvic floor prolapse is severe and hasn't improved with a pessary.

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I am unable to understand and give consent for treatment.

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I need my Botox injections to be done in an Operating Room or while I'm sedated.

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I have used more than 300 units of Botox for another condition in the last 3 months.

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I currently have a urinary tract infection that hasn't been treated.

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I have a history of bladder issues, including cancer or severe inflammation.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, & 12 months post injection. results will be compared at the end of the 12 months. for reporting.