Optimal Injection Interval for Intra-Detrusor Botulinum Toxin

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Louisiana State University Health Sciences Center in New Orleans
Study ID
NCT06483217
Status
Not Yet Recruiting

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Conditions

  • Overactive Bladder
  • Urge Urinary Incontinence
  • Urinary Incontinence
  • Urinary Urgency

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patient-directed follow up — BEHAVIORAL
    Patients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval.

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Jul 2024
Primary completion
Jul 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of care
    Standard 6 month post-operative follow up interval for repeat injection
  • Experimental: Patient-directed follow up
    Post-operative follow up interval for repeat injection decided by patient based on OAB symptomatology (3-12 months)

Primary Outcome Measure

Injection interval [ Time Frame: Days from initial injection to repeat injection, up to 365 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louisiana State University Health Science CenterNew OrleansLouisiana70112
Zachary Selzler, MD
[email protected]
504-568-2383
Zachary Selzler, MD (SUB_INVESTIGATOR)
Lisa Peacock, MD (PRINCIPAL_INVESTIGATOR)

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