Clinical trial NCT05157295: Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial
Official title: Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overactive Bladder Syndrome
Overactive Bladder
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group of participants will receive the "experimental" treatment, which is 4 injections, and the other group of participants will receive the "standard" treatment, which is 20 injections.
Primary purpose: TREATMENT

Brief summary: Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Current standard of practice involves 100 U of onabotulinumtoxinA diluted in 10 ml saline cystoscopically injected into approximately 20 different detrusor muscle sites equally distributed along the posterior bladder wall and dome. This treatment was classically done in the operating room under general anesthesia, but now is typically performed in an office setting using local anesthesia (lidocaine) as this is more feasible and tolerable. Patients can experience discomfort and pain with each injection. Evidence has also shown that administering the same dose of onabotulinumtoxinA into fewer injection sites in the detrusor muscle (ranging from 3 to 10) results in equivalent efficacy compared to the current standard. However, it has yet to be determined if there is a significant difference in patient satisfaction and tolerability when the procedure is administered in an office setting using the same dosage with fewer injections. Our study aims to assess whether patient tolerance and satisfaction of intravesicular onabotulinumtoxinA increases with the use of 4 detrusor injections as opposed to 20 injections when performed in an office setting on women with OAB.


Eligibility criteria: Inclusion Criteria:

* females, adults 18 years of age and older, diagnosed with OAB

Exclusion Criteria:

* bladder pathology including nephrolithiasis, active urinary tract infection, bladder trauma, neurogenic bladder, patients who have previously received intravesical onabotulinumtoxin A injections, pregnant patients, minor patients, male patients

Primary outcomes:
measure: Perceived pain of each participant before, during, and after the procedure on a scale of 0-10
timeFrame: within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention
Secondary outcomes:
measure: The Benefit, Satisfaction, and Willingness to Continue of each participant after the procedure
timeFrame: 2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure
measure: Change in extent of Overactive Bladder Symptoms before and after receiving the procedure
timeFrame: Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
measure: The Prevalence of complications with botox after receiving the procedure
timeFrame: 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Augusta University
name: Jennifer Lanzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Augusta University
name: Emily Grandprey, DO
role: STUDY_DIRECTOR
affiliation: Augusta University
name: Emily Lluch
role: STUDY_DIRECTOR
affiliation: Augusta University
name: Ahana Gaurav
role: STUDY_DIRECTOR
References: