Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial
Who is this study for? Adult female patients with Urinary Incontinence
What treatments are being studied? Onabotulinumtoxin A
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Women \>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.
• Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.
Locations
United States
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
University of South Florida Health South Tampa Center for Advanced Healthcare
RECRUITING
Tampa
Contact Information
Primary
Eric S Chang, MD
ericchang@usf.edu
813-259-8500
Backup
Allison Wyman, MD
awyman@usf.edu
813-259-8500
Time Frame
Start Date: 2019-10-09
Estimated Completion Date: 2021-06-01
Participants
Target number of participants: 60
Treatments
Experimental: 5 Injections
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.
Active_comparator: 20 Injections
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.
Related Therapeutic Areas
Sponsors
Leads: University of South Florida
Collaborators: Medstar Health Research Institute