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Neurotoxin

Patient-directed follow up for Urinary Incontinence

N/A
Waitlist Available
Led By Lisa Peacock, MD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* diagnosis of overactive bladder, detrusor overactivity, urinary urgency, urinary frequency, nocturnal polyuria, or urge urinary incontinence
* pursuing treatment with intravesical botulinum toxin injections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days from initial injection to repeat injection, up to 365 days
Awards & highlights

Summary

The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are: * Does the time between repeat injections differ from the 6-month standard when it is based on patient symptoms alone? * Does symptom control or patient satisfaction change when patients control their own follow up times? Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.

Who is the study for?
This trial is for individuals with overactive bladder and related urinary issues who have previously responded to botulinum toxin injections. Participants will decide when they need follow-up treatments rather than following a standard schedule.
What is being tested?
The study tests if patient-directed follow-up times for botulinum toxin injections into the bladder are more effective than the usual 6-month interval in managing symptoms of overactive bladder.
What are the potential side effects?
Botulinum toxin may cause side effects like urinary tract infections, difficulty urinating, or discomfort at the injection site. Some people might also experience general weakness.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days from initial injection to repeat injection, up to 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and days from initial injection to repeat injection, up to 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Injection interval
Secondary outcome measures
Patient Satisfaction
Symptom Control

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patient-directed follow upExperimental Treatment1 Intervention
Post-operative follow up interval for repeat injection decided by patient based on OAB symptomatology (3-12 months)
Group II: Standard of careActive Control1 Intervention
Standard 6 month post-operative follow up interval for repeat injection

Find a Location

Who is running the clinical trial?

Louisiana State University Health Sciences Center in New OrleansLead Sponsor
119 Previous Clinical Trials
44,928 Total Patients Enrolled
Lisa Peacock, MDPrincipal InvestigatorLouisiana State University Health Science Center - New Orleans
~67 spots leftby Jul 2025
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