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Neurotoxin

Botox for Overactive Bladder

N/A
Recruiting
Led By Jennifer Anger, MD, MPH
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21 years or older
Female
Must not have
Age less than 21 years
Inability to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about 10 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will use MRI and urodynamics to study how botulinum toxin alleviates symptoms of overactive bladder in women who haven't responded to other treatments.

Who is the study for?
This trial is for women aged 21 or older who have overactive bladder symptoms that haven't improved with medication. Participants must be able to give informed consent and should not be claustrophobic, as the study involves MRI technology.
What is being tested?
The study tests how well botulinum toxin (Botox) works in treating overactive bladder when its effects are monitored using a special type of MRI called cineMRI combined with urodynamics. This aims to understand Botox's impact on bladder function.
What are the potential side effects?
While the side effects specific to this trial aren't listed, common side effects of Botox may include urinary tract infections, painful urination, inability to empty your bladder on your own, and localized pain where the injection was given.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I am female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 21 years old.
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I am unable to understand and agree to the study's details.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~about 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and about 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time-resolved views by CineMRI with urodynamics on overactive bladder physiology
Other study objectives
Improvement in overactive bladder symptoms by smooth muscle paralysis via botulinum toxin injection (100U)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Botulinum toxin and cineMRI-UDS

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
163,354 Total Patients Enrolled
Jennifer Anger, MD, MPHPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Botulinum toxin (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT02315950 — N/A
Overactive Bladder Research Study Groups: Arm 1
Overactive Bladder Clinical Trial 2023: Botulinum toxin Highlights & Side Effects. Trial Name: NCT02315950 — N/A
Botulinum toxin (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02315950 — N/A
~1 spots leftby Dec 2025
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