Botox as a Treatment for Interstitial Cystitis in Women - Full Text View

Sponsors and Collaborators:	University of Washington Paul G. Allen Family Foundation
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00194610

Purpose

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.

Condition	Intervention	Phase
Painful Bladder Syndrome Interstitial Cystitis	Drug: Botulinum Toxin A (Botox)	Phase IV

MedlinePlus related topics: Botox Interstitial Cystitis

Drug Information available for: Clostridium botulinum toxin Botulinum toxin A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial

Further study details as provided by University of Washington:

Primary Outcome Measures:

3 month follow-up visit [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Voiding/symptom diaries - change in voiding and pain [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
Symptoms [ Time Frame: across 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Ask P.I. for details

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194610

Contacts

Contact: Sharon Downing, RN

206-598-0850

sdowning@u.washington.edu

Locations

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

Sponsors and Collaborators

University of Washington

Paul G. Allen Family Foundation

Investigators

Principal Investigator:

Jane L Miller, MD

University of Washington

More Information

Responsible Party:	University of Washington ( Jane L. Miller, MD, Principal Investigator )
Study ID Numbers:	25398-D
Study First Received:	September 13, 2005
Last Updated:	December 27, 2008
ClinicalTrials.gov Identifier:	NCT00194610
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Cystitis, Interstitial
Botulinum Toxins
Cystocele
Urologic Diseases

Urinary Bladder Diseases
Cystitis
Pain
Botulinum Toxin Type A

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anti-Dyskinesia Agents
Therapeutic Uses
Syndrome

Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009