Botox as a Treatment for Interstitial Cystitis in Women

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00194610
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: University of Washington
• Public title: Botox as a Treatment for Interstitial Cystitis in Women
• Scientific title: Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial
• Date of first enrolment: May 2004
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00194610
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Claire Yang, MD
• Affiliation: University of Washington

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Interstitial Cystitis

Painful Bladder Syndrome

Intervention(s)

Other: normal saline

Drug: Botox

Primary Outcome(s)

Chronic Prostatitis Symptom Index (CPSI-F) [Time Frame: 3 months]

Secondary ID(s)

25398-D

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Paul G. Allen Family Foundation

Results

• Results available: Yes
• Date Posted: 12/10/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00194610