Status:
COMPLETED
Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Allergan
Conditions:
Interstitial Cystitis
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief 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 ...
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 Onabo...
Eligibility Criteria
Inclusion
- Adult females between the ages of 18 and 80 inclusive
- Patients being treated for IC who are refractory to conservative management and oral therapy.
- willing and able to initiate catheterization post-treatment
Exclusion
- Any history of bladder cancer, uterine cancer, ovarian cancer, vaginal cancer, urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida, cyclophosphamide treatment, radiation treatment to the pelvis, bladder tuberculosis, genital herpes.
- Currently on or requiring anti-platelet/anti-coagulant concomitant therapy or having been on anti-platelet/ anti-coagulant therapy within the past 3 months
- Pregnancy. Pregnancy is an absolute contraindication to undergoing these procedures. Thus, as part of their normal pre-operative work up, which is standard of care, pregnancy tests are administered if they are women of child-bearing age, are sexually active, and are within 10 days of the normal menstrual period. If positive, they will be excluded as they will not undergo the procedure.
- An active urinary tract infection as shown during clean-catch urinalysis at screening visit. Subject may be re-screened if UTI is successfully treated and urinalysis is negative at rescreening.
- A history of hypersensitivity or allergy to any botulinum toxin preparation
- A post-void residual (PVR) urine volume \>200mL at baseline
- Treatment with botulinum toxin during the 12 week period prior to the trial
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02297100
Start Date
December 1 2014
End Date
January 10 2018
Last Update
September 5 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27103