NCT03523091

OnabotulinumtoxinA Bladder Injection Study

Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10 sites. Patient satisfaction and the effectiveness of the medication will be evaluated.

Detailed description

Overactive bladder (OAB) is a common condition which often has a negative impact on health related quality of life. Primary and secondary treatments include behavior modification, pelvic floor physical therapy, and OAB medications. OnabotulinumtoxinA (BTX) is a well-established third line therapy for refractory OAB. BTX has transitioned over the years from a procedure conducted in the operating room to one that is commonly done in the clinic or physician office. While ten injection sites is commonly practiced, there has been continuing interest in reducing the number of injection sites to make the technique more tolerable and more efficient. In this study, refractory OAB patients will be randomized to receive 100 units of BTX over 3 or 10 injection sites. The investigators hypothesize that decreasing the number of injection sites may improve patient tolerability and satisfaction with this office-based procedure and potentially reduce the rates of adverse events including hematuria and urinary tract infection.

Conditions

• Overactive Bladder
• Overactive Bladder Syndrome
• Urinary Urgency
• Urinary Incontinence
• Urinary Frequency/Urgency
• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA 100Unit Injection	Initial treatment with the option of repeat injections every 3 months

Timeline

• Start date: 2018-08-08
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2018-05-14
• Last updated: 2022-02-10
• Results posted: 2022-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study