Optimal Injection Interval for Intra-Detrusor Botulinum Toxin
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLouisiana State University Health Sciences Center in New Orleans
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of overactive bladder, detrusor overactivity, urinary urgency, urinary frequency, nocturnal polyuria, or urge urinary incontinence
pursuing treatment with intravesical botulinum toxin injections
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Patient-directed follow up
BehavioralPatients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Standard of careNo intervention 0 interventions
Group B: Patient-directed follow upExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Injection interval
time to repeat injection (days)
Time frame
Days from initial injection to repeat injection, up to 365 daysSecondary outcomes
1
Patient Satisfaction
Scores from the Surgical Satisfaction Questionnaire (SSQ-8), which contains 8 questions on satisfaction with a likert scale rating of 1-5. Higher scores indicate higher patient satisfaction.
Time frame
1-2 weeks post-injection2
Symptom Control
Scores from the Overactive Bladder Assessment Tool (OAB-Q), which contains 5 questions on symptoms and 5 questions on quality of life with a likert scale rating of 0-5. Higher scores on the symptom section indicate WORSE overactive bladder symptoms and higher scores on the quality of life section indicate higher levels of bother/WORSE quality of life.
Time frame
baseline scores immediately pre-injection, post-treatment scores 1-2 weeks post-injectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: