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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19 October 2017 |
Main ID: |
NCT00194610 |
Date of registration:
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13/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Botox as a Treatment for Interstitial Cystitis in Women
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Scientific title:
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Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial |
Date of first enrolment:
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May 2004 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00194610 |
Study type:
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Interventional |
Study design:
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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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Claire Yang, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women ages 18 and older
- Diagnosis of interstitial cystitis
- Subject has severity/stage of disease: at least 12 voids/day with the presence of
pelvic pain
- Ability to follow study instructions and likely to complete all required visits.
- Negative urine pregnancy test on the day of treatment prior to the administration of
study medication (for females of childbearing potential; if applicable)
Exclusion Criteria:
- Use of any medications that might interfere with neuromuscular function
- Any medical condition that may put the subject at increased risk with exposure to
Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
lateral sclerosis, or any other disorder that might interfere with neuromuscular
function
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study or
who think that they may be pregnant at the start of the study, or females of
childbearing potential who are unable or unwilling to use a reliable form of
contraception during the study
- Known allergy or sensitivity to any of the components in the study medication
- Concurrent participation in another investigational drug or device study, or
participation in the 30 days immediately prior to study enrollment.
- Stress incontinence
- Urinary tract infection at time of enrollment
- Overtly psychotic or suicidal
- Pain from another source in the genital tract such as kidney stones or neoplasm
- Having had radiation therapy
- History of genitourinary tuberculosis
- Neurological abnormalities such as stroke, brain tumors, spinal cord injury and
Parkinson's or Alzheimer's disease
- Currently taking antibiotics
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Painful Bladder Syndrome
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Interstitial Cystitis
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Intervention(s)
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Drug: Botox
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Other: normal saline
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Primary Outcome(s)
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Chronic Prostatitis Symptom Index (CPSI-F)
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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