Phase 4
N=20
Botox as a Treatment for Interstitial Cystitis in Women
Painful Bladder Syndrome · Interstitial Cystitis
Bottom Line
View on ClinicalTrials.gov: NCT00194610 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Chronic Prostatitis Symptom Index (CPSI-F) — 29.6; 35.2 Total CPSI-F
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Botox (Drug); normal saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Prostatitis Symptom Index (CPSI-F) |
29.6; 35.2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00194610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.