Overview

Botox as a Treatment for Interstitial Cystitis in Women

Status:
Completed

Trial end date:
2010-09-01

Target enrollment:
0

Participant gender:
Female

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 muscle pain is primarily the cause of bladder problems. Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the neuromuscular junction. It has been shown that this mechanism relieves pain in a number of muscle spasm-related syndromes. Because, at present, there is little effective therapy available for patients with interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve bladder and pelvic pain in these patients.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Washington

Collaborator:

Paul G. Allen Family Foundation

Treatments:

abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA

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