NCT02297100

Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

The Impact of Injection Location on the Efficacy of Intravesicular Onabotulinumtoxin A in Interstitial Cystitis--Phase 4

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A in interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®, is a medication that comes from the bacteria Clostridium botulinum. It works by blocking the release of the neurotransmitter acetylcholine(a chemical messenger that carries signals between nerve cells and other cells in the body). Blocking that neurotransmitter results in decreased muscle activity.

Detailed description

The purpose of this study is to evaluate the efficacy of intravesicular Onabotulinumtoxin A injections for the treatment of interstitial cystitis (IC). Specifically, we hypothesize that trigonal Onabotulinumtoxin A injections is an effective treatment for IC and will result in more subjective and objective symptom relief than posterior wall Onabotulinumtoxin A injections.

Conditions

• Interstitial Cystitis

Interventions

Type	Name	Description
DRUG	Onabotulinumtoxin A	100 units of botox spread out among 10 separate injections
PROCEDURE	injections upper aspect of trigone of urinary bladder	We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
PROCEDURE	injections on posterior bladder wall excluding the trigone	We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-01-10
• Completion: 2018-01-10
• First posted: 2014-11-21
• Last updated: 2018-09-05
• Results posted: 2018-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study