Botox as a Treatment for Interstitial Cystitis in Women

Condition(s) targeted: Painful Bladder Syndrome; Interstitial Cystitis

Intervention: Botulinum Toxin A (Botox) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Jane L Miller, MD, Principal Investigator, Affiliation: University of Washington

Overall contact:
Sharon Downing, RN, Phone: 206-598-0850, Email: sdowning@u.washington.edu

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 100 units of botulinum toxin A will relieve bladder and pelvic pain in these patients.

Official title: Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome: 3 month follow-up visit

Secondary outcome:

Voiding/symptom diaries - change in voiding and pain

Symptoms

Detailed description: Screening Visit:

After being screened by her caregiver, 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 be randomized.

Then, for women of childbearing age, a pregnancy test will be done.

Next, we will ask the patient to fill out baseline study forms and she will be given a Voiding Diary. She will also be asked to provide a urine sample which will be processed for chemistry.

Injection Visit:

This visit will be scheduled one week after the Screening Visit. First, a standard history and physical will be done. Then the clinician will proceed with the injection. The subject will receive an injection of not more than 5 ml of 1% lidocaine without epinephrine at the site of the botulinum toxin A injection.

Next, 25 units of Botox will be injected, via the transvaginal route, on either side of the

bladder neck. The remaining 50 units will be injected (in 2 - 25 unit doses) into other

pelvic sites that the patient has identified as tender during the patient examination.

1 Month Post Injection Mailing: The patient will be mailed a packet containing follow-up questionnaires and asked to mail them back upon completion.

6 Week Urine Collection Visit: Two weeks after receiving her study injection, we will ask the patient to go to the Urology Clinic and provide a urine sample.

2 Month Post Injection Mailing: Same as 1 Month Post Injection Visit.

3 Month Post Visit: The subject will be asked to fill out follow-up questionnaires and will be asked to turn in her last set of Voiding Diaries.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Sharon Downing, RN, Phone: 206-598-0850, Email: sdowning@u.washington.edu

University of Washington - Urology Clinic, Seattle, Washington 98195, United States; Recruiting

Starting date: May 2004
Ending date: December 2010
Last updated: June 17, 2008