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Led by University of South Florida · Updated on 2020-11-05
60
Participants Needed
2
Research Sites
21 weeks
Total Duration
Researchers are studying the effects of different injection methods of onabotulinumtoxin A for women with overactive bladder or urgency urinary incontinence that has not improved with medication. This study compares outcomes between giving a 100 unit dose split into 5 injections versus 20 injections. The purpose is to see if the number of injections affects post-procedural pain and other treatment results. Participants receive a single procedure where their bladder is prepared with lidocaine. Then, onabotulinumtoxin A is injected into the bladder muscle either as 5 injections of 2 mL each or 20 injections of 0.5 mL each, totaling 100 units diluted in 10 mL. Both groups undergo cystoscopy with the same needle type and injection spacing. During the study, researchers will measure pain within 5 minutes after the procedure. They will also track procedure duration, treatment response at 6 weeks, and any urinary tract infections or retention up to 12 weeks afterward. Participants are monitored closely, with all visits and assessments designed to evaluate safety and treatment outcomes over this period.
CONDITIONS
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
E
Eric S Chang, MD
A
Allison Wyman, MD
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University of South Florida
Lead Sponsor
Medstar Health Research Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | OnabotulinumtoxinA 100 U (5 injections) | OnabotulinumtoxinA 100 U (20 injections) |
|---|---|---|
| What it is | OnabotulinumtoxinA 100 units given as 5 intravesical injections during one cystoscopic procedure. | OnabotulinumtoxinA 100 units given as 20 intravesical injections during one cystoscopic procedure. |
| Role in trial | Investigational arm; evaluates whether fewer injections reduce post-procedural pain for women with overactive bladder. | Active comparator; standard 20-injection method used to assess pain and treatment outcomes against fewer injections. |
| Primary use or clinical purpose | Treat symptoms of overactive bladder and urgency incontinence through intravesical administration of onabotulinumtoxinA, aiming to decrease procedure pain by using fewer injections. | Treat symptoms of overactive bladder and urgency incontinence through intravesical administration of onabotulinumtoxinA using traditional 20-injection technique. |
| How it is given or performed | The 100-unit dose is injected at 5 bladder sites under cystoscopy without sedation, anesthesia, or catheterization. | The 100-unit dose is injected at 20 bladder sites under cystoscopy without sedation or anesthesia. |
| Evidence status | Evidence for 5-injection method comes from randomized trial data, which evaluates short-term post-procedural pain and treatment outcomes; broader published evidence is limited to recent studies. | Clinical evidence supports 20-injection method as routine and effective for symptom control; pain and safety data are established from multiple published sources. |
| Important limitations | Reductions in injection number may lessen immediate pain but the trial has a limited sample size; longer-term outcome and safety need further validation. | Standard method is established but may cause more immediate pain than fewer injections; small study size limits full assessment of safety and efficacy differences. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants receive a single intradetrusor injection of onabotulinumtoxin A as either 5 or 20 injections in one procedure to treat overactive bladder.
1 procedure visit (in-person)
Duration - Up to 12 weeks post-procedure
Participants are monitored for treatment response, urinary tract infections, and urinary retention after the procedure.
Visits at approximately 6 and 12 weeks post-procedure
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Eric S Chang, Nancy Ringel, Katherine L Woodburn...
https://pubmed.ncbi.nlm.nih.gov/35543540/University of South Florida
Lead Sponsor
Medstar Health Research Institute
Collaborating Sponsor
