Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02297100 |
Date of registration:
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30/09/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
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Scientific title:
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The Impact of Injection Location on the Efficacy of Intravesicular Onabotulinumtoxin A in Interstitial Cystitis--Phase 4 |
Date of first enrolment:
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December 2014 |
Target sample size:
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27 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02297100 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert J Evans, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Wake Forest University Health Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adult females between the ages of 18 and 80 inclusive
2. Patients being treated for IC who are refractory to conservative management and oral
therapy.
3. willing and able to initiate catheterization post-treatment
Exclusion Criteria:
1. 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.
2. Currently on or requiring anti-platelet/anti-coagulant concomitant therapy or having
been on anti-platelet/ anti-coagulant therapy within the past 3 months
3. 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.
4. 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.
5. A history of hypersensitivity or allergy to any botulinum toxin preparation
6. A post-void residual (PVR) urine volume >200mL at baseline
7. Treatment with botulinum toxin during the 12 week period prior to the trial
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Drug: Onabotulinumtoxin A
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Procedure: injections on posterior bladder wall excluding the trigone
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Procedure: injections upper aspect of trigone of urinary bladder
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Primary Outcome(s)
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The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire
[Time Frame: 30 and 90 days post-treatment]
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The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.
[Time Frame: 30 and 90 days post treatment]
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Secondary Outcome(s)
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Change in Patient Performance in Uroflowmetry.
[Time Frame: 30 days and 90 days post treatment]
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Secondary ID(s)
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IRB00026734
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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