Trial Information

Summary: Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Prospective Double-Blinded Controlled Trial.

This is a randomized, prospective double-blinded controlled trial to determine if a three-week trial of intravesical alkalized Lidocaine instillation decreases symptoms of OAB more than instillation of normal saline.

If you participate, you will be asked to come in for a screening visit, 2 treatment sessions per week for 3 weeks and follow up visits after 6 weeks, 3 months, 6 months and 1 year.

Background:
Women with OAB have the unpleasant sensation of needing to urinate urgently, and may occasionally lose urine as a result of that urgency. Up to 17% of women in the U.S. may suffer from this condition, with significant limitations in physical and social activity. Current drugs do not treat everyone, and also may have irritating side effects. Our study looks at local anesthetic solution placed directly into the bladder (with a small catheter) as a new approach for treating this problem. This will be compared with a placebo instillation of inert saline for effectiveness and reduced side effects.

Inclusion Criteria:

• Female patient, 18 years of age and older
• Overactive bladder defined as
  • Urinary frequency defined as eight or more voids in a 24 hour period > 50% of days of the week
  • Symptoms of urgency
  • Symptoms of at least three months’ duration

Exclusion criteria:

• positive urine culture in the past month , or more than 3 episodes of bladder infection in the last 2 months
• stress or overflow urinary incontinence (determined by clinician) if more than 14 episodes of urinary incontinence per week; also insensate incontinence
• pregnancy
• seizure disorder or clinically significant renal disease, allergy to Lidocaine, uninvestigated hematuria, or history of urinary/reproductive tract malignancy
• post-void residual more than 100 cc

Condition: Overactive Bladder

Overall Recruiting Status: Recruiting

Trial Listing Approval: Yes, the study listing is IRB approved

Research Ethics Review: Evanston Northwestern Healthcare Institutional Review Board

Intervention Type: Lidocaine vs saline placebo

Primary Sponsor: The Berlex Foundation

Study Start Date: June 2006

Target Number of Subjects: 100

Outcomes:

• To determine the efficacy of intravesical alkalized Lidocaine for short-term symptom relief of overactive bladder in women.
• To determine the long-term efficacy of intravesical alkalized Lidocaine to prevent relapse of overactive bladder symptoms in women.
• To determine the effect of intravesical alkalized Lidocaine on volume of first sensation with filling cystometry.

For more information about the study, please contact:

If you would like to learn more about participating in this study, please send an e-mail message using the form below.