MedTrace Logo

Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

NCT02297100 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-09-05

Study results available
· View outcomes & findings →

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.

Conditions

  • Interstitial Cystitis

Interventions

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.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Robert J Evans, M.D. · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-01-10
Completion
2018-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02297100 on ClinicalTrials.gov