Botox as a Treatment for Interstitial Cystitis in Women

NCT00194610 | Completed Phase 4 Results

• 1 other identifier: 25398-D
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Painful Bladder Syndrome; Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Chronic Prostatitis Symptom Index (CPSI-F)

  CPSI-F was adapted from the CPSI, in order to document the location of pain, with working pertinent to female anatomy. The CPSI-F was scored on a range of 0-83 (0-61 in the pain domain, 0-10 in the urination domain, 0-6 in the impact of symptoms domain, and 0-6 in the quality of life domain), with higher scores denoting worse symptoms.

  3 months

Study Arms (2)

Botox injection

EXPERIMENTAL

Subjects were injected with Botulinum toxin A in a mix of 50 U diluted in 2 cubic centimeters of normal saline. With the subjects in the dorsal lithotomy position, one injection of 25 international units was given into the bladder neck at the 3 o'clock position and another of 25 international units was given into the 9 o'clock position

Drug: Botox

Normal saline

PLACEBO COMPARATOR

Subjects were injected in the bladder neck with 1 cubic centimeter normal saline into the 3 o'clock and 6 o' clock positions in the perineum, while in the dorsal lithotomy position

Other: normal saline

Interventions

Botox DRUG

Botox 25 international units per injection injected in two places in the bladder neck, with option to inject two other tender points with 25 units each

Also known as: Botulinum Toxin A

Botox injection

normal saline OTHER

Normal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Paul G. Allen Family Foundation: collaborator

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Claire Yang, MD
• Organization: University of Washington

cyang@uw.edu

206-744-6384

Study Officials

• Claire Yang, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: May 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2010
• Last Updated: October 12, 2012
• Results First Posted: October 12, 2012

Record last verified: 2012-09