A Phase 4 interventional study of OnabotulinumtoxinA in Overactive Bladder Syndrome and Overactive Bladder, sponsored by Augusta University. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by Augusta University · Phase 4, Interventional, and Treatment
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
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Exclusion Criteria:
100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 4 different detrusor muscle sites along the posterior bladder wall and dome.
Drug: OnabotulinumtoxinA
100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 20 different detrusor muscle sites along the posterior bladder wall and dome.
Drug: OnabotulinumtoxinA
100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites
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).
Time frame: within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention
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).
Time frame: 2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure
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).
Time frame: Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
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.
Time frame: 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Augusta University