Back to resultsIntravesicular Onabotulinumtoxin A in Interstitial Cystitis
Primary Purpose
Interstitial Cystitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Onabotulinumtoxin A
injections upper aspect of trigone of urinary bladder
injections on posterior bladder wall excluding the trigone
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring women, interstitial cystitis, bladder pain syndrome, botox, onabotulinum toxin A
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Wake Forest School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botox upper aspect trigone
botox periphery of trigone
Arm Description
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Outcomes
Primary Outcome Measures
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes.
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes.
Secondary Outcome Measures
Change in Patient Performance in Uroflowmetry.
Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.
Full Information
NCT ID
NCT02297100
First Posted
September 30, 2014
Last Updated
August 7, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT02297100
Brief Title
Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
Official Title
The Impact of Injection Location on the Efficacy of Intravesicular Onabotulinumtoxin A in Interstitial Cystitis--Phase 4
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
women, interstitial cystitis, bladder pain syndrome, botox, onabotulinum toxin A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botox upper aspect trigone
Arm Type
Experimental
Arm Description
Subjects in the experimental cohort will receive a one time dose of 100 units of Onabotulinumtoxin A diluted in 10 mL of preservative free normal saline and injected in 1.0 mL boluses in a set pattern across the upper aspect of the trigone of the urinary bladder.
Arm Title
botox periphery of trigone
Arm Type
Active Comparator
Arm Description
Each group will receive a total of 100 units of botox spread out among 10 separate injections. Subjects in the control group will have 10 injections made about the periphery of the trigone. The control cohort will receive a one time dose of Onabotulinumtoxin A using the same dilution and number of boluses, but boluses will be administered at random sites on the posterior bladder wall (excluding the trigone).
Intervention Type
Drug
Intervention Name(s)
Onabotulinumtoxin A
Other Intervention Name(s)
Botox
Intervention Description
100 units of botox spread out among 10 separate injections
Intervention Type
Procedure
Intervention Name(s)
injections upper aspect of trigone of urinary bladder
Intervention Description
We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
Intervention Type
Procedure
Intervention Name(s)
injections on posterior bladder wall excluding the trigone
Intervention Description
We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
Primary Outcome Measure Information:
Title
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
Description
The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes.
Time Frame
30 and 90 days post treatment
Title
The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
Description
The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes.
Time Frame
30 and 90 days post-treatment
Secondary Outcome Measure Information:
Title
Change in Patient Performance in Uroflowmetry.
Description
Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.
Time Frame
30 days and 90 days post treatment
Other Pre-specified Outcome Measures:
Title
Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.
Time Frame
30 days and 90 days post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Evans, M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
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Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
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