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Botox as a Treatment for Interstitial Cystitis in Women

NCT00194610 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-10-12

Study results available
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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

Interventions

DRUG

Botox

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

OTHER

normal saline

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

Sponsors & Collaborators

Principal Investigators

  • Claire Yang, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2009-06-30
Completion
2010-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00194610 on ClinicalTrials.gov