Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial

Overactive Bladder Clinical Trial

Official title:

Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05157295
• Other study ID #: 1791493
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2021
• Source: Augusta University
• Contact: Stacy Carrigan
• Phone: 7067214959
• Email: scarrigan[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• OnabotulinumtoxinA
100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived pain of each participant before, during, and after the procedure on a scale of 0-10	The Pain Survey is a self-reported instrument used to assess pain before, during, and after a procedure. Possible scores range from 0 (no pain) to 10 (worst pain possible).	within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention
Secondary	The Benefit, Satisfaction, and Willingness to Continue of each participant after the procedure	The Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire is a validated instrument administered by the physician. It asks participants if they had benefit, satisfaction, and a willingness to continue from a specific treatment. If yes, responses range from 1(little benefit, little, satisfaction, a little bit willing) to 2(much benefit, very satisfied, very willing).	2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure
Secondary	Change in extent of Overactive Bladder Symptoms before and after receiving the procedure	The Overactive Bladder questionnaire (OAB-q) short form is a validated instrument that measures the extent to which participants have various symptoms of OAB over the past 4 weeks. The responses range from 1(not at all) to 6(a very great deal).	Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
Secondary	The Prevalence of complications with botox after receiving the procedure	The Complications with Botox survey is an instrument used to measure if and how many times participants experienced UTIs, difficulty urinating, or hematuria after the Botox procedure. Participants self-report the number of times if they have experienced the side effect.	2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure