Optimal Injection Interval for Intra-Detrusor Botulinum Toxin: A Randomized Controlled Trial Utilizing a Patient-Centered Approach
Louisiana State University Health Sciences Center in New Orleans
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.
Description
Overactive bladder (OAB) is defined by symptoms of urinary urgency, frequency, or nocturia with or without incontinence in the absence of urinary tract infection or other attributable pathology. This disease affects up to 40% of women in the United States and can have a significant impact on quality of life. It is expected to increase in prevalence with the aging US population. There are a wide variety of treatment options for OAB which range from fluid management and lifestyle modifications (first line therapy), pelvic floor physical therapy and oral medications (second line therapy), and pro…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * diagnosis of overactive bladder, detrusor overactivity, urinary urgency, urinary frequency, nocturnal polyuria, or urge urinary incontinence * pursuing treatment with intravesical botulinum toxin injections Exclusion Criteria: \- non-OAB diagnosis such as pelvic pain or interstitial cystitis
Interventions
- BehavioralPatient-directed follow up
Patients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval.
Location
- Louisiana State University Health Science CenterNew Orleans, Louisiana