Status:
COMPLETED
Botox as a Treatment for Interstitial Cystitis in Women
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Paul G. Allen Family Foundation
Conditions:
Painful Bladder Syndrome
Interstitial Cystitis
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor mus...
Detailed Description
Screening Visit: After being screened by her medical provider, the patient will be given the opportunity to ask questions about the study. She will then be asked to read and sign the consent and then...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00194610
Start Date
May 1 2004
End Date
September 1 2010
Last Update
October 12 2012
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