A Phase 4 interventional study of OnabotulinumtoxinA 100 UNT in Urinary Bladder, Overactive, Incontinence, Urge and Incontinence, Urinary, sponsored by University of South Florida. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by University of South Florida · Phase 4, Interventional, and Treatment
Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.
The intradetrusor injection of onabotulinumtoxin A for treatment of idiopathic overactive bladder and urgency urinary incontinence refractory to anticholinergic or β-agonist treatment was approved by the United States Food and Drug Administration (FDA) in 2013. Since then, multiple randomized placebo-controlled trials have demonstrated the effectiveness of the treatment. Currently, Allergan, Inc. and the FDA recommend the intravesical administration of onabotulinumtoxin A with dilution to 100 units/10 mL with preservative-free 0.9% Sodium Chloride Injection, as 20 injections of 0.5 mL each. Currently, in clinical practice there has been no standardization in the number of intravesical injections, with a single dose of onabotulinumtoxin A being administered in as few as 1 injection to as many as 40 injections into the detrusor muscle. Given the increasing use of this treatment modality, the investigators aim to compare patient outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to the recommended 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence refractory to medical treatment.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 5 injections of 2 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.
Drug: OnabotulinumtoxinA 100 UNT
Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 20 injections of 0.5 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.
Drug: OnabotulinumtoxinA 100 UNT
Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.
Also known as: BOTOX
Pain from procedure: score
Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion
Time frame: Within 5 minutes of procedure completion
Duration of procedure
Total time of procedure defined as time cystoscope is introduced into the bladder to the time the cystoscope is removed from the bladder after completion of all injections
Time frame: Procedure time
Positive treatment response
The percentage of patients with a positive treatment response based on answering a Global Response Assessment given 6 weeks after completion of procedure
Time frame: 6 weeks post-procedure
Urinary tract infections
Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure
Time frame: 12 weeks post-procedure
Urinary retention
Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure
Time frame: 12 weeks post-procedure
Plan to share: No — All statistical analyses will be performed at the University of South Florida. The investigators performing review of data and statistical analyses will not require the use of, or have access to any personally identifying patient information from either the primary or secondary site of the study.
Started Oct 2019 (actual). Primary completion is estimated for Jan 2021, 14 months after the start.
Of 42 non-industry phase 4 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 14 months is below that.
Counting every sponsor, half of 54 studies reached it within 23 months; a quarter within 15 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Onabotulinum toxin A