Botulinum Toxin Injection Interval for Overactive Bladder

This study is looking at how often women with overactive bladder (OAB) should receive botulinum toxin (Botox) injections. OAB causes symptoms like a sudden urge to urinate and frequent urination. The study wants to see if letting patients decide when they need their next injection, based on their symptoms, works better than the standard 6-month schedule. You would receive a standard botulinum toxin injection into your bladder. Then, you'd either follow up at a set 6-month interval or when your symptoms return. The main goal is to see if patient-directed follow-up changes the time between injections and improves symptom control and satisfaction. This study is for women aged 18 and older who have been diagnosed with OAB and are considering botulinum toxin injections. The study aims to enroll 100 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 women. Participants will be randomly assigned to either a standard 6-month follow-up or a patient-directed follow-up schedule.
What's involved
You would undergo a standard botulinum toxin injection into your bladder. You would then follow up for repeat injections either at a 6-month interval or at your own self-determined time based on your symptoms.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, injection interval, will be measured for up to 365 days from the initial injection.

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NCT06483217

Optimal Injection Interval for Intra-Detrusor Botulinum Toxin

UNKNOWN
NAAges 18+InterventionalTreatment
Louisiana State University Health Sciences Center in New Orleans
~100 participants
Updated 2024-07-17 on ClinicalTrials.gov
What's tested:Patient-directed follow up

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Injection interval
Measured over Days from initial injection to repeat injection, up to 365 days
Overactive Bladder
Urinary Urgency
Urinary Incontinence
Urge Urinary Incontinence
1 sites across 1 states
Louisiana1
  • Lisa Peacock, MD · PRINCIPAL_INVESTIGATOR · Louisiana State University Health Science Center - New Orleans

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Eligibility criteria

Inclusion

diagnosis of overactive bladder, detrusor overactivity, urinary urgency, urinary frequency, nocturnal polyuria, or urge urinary incontinence
pursuing treatment with intravesical botulinum toxin injections
  • Injection intervalDays from initial injection to repeat injection, up to 365 days

    time to repeat injection (days)