The ABC Study: Anticholinergics versus Botox Comparison in Women with Urge Incontinence

ABC stands for Anticholinergic vs. Botox Comparison study. This study will compare the effect of Botox injected into the bladder to pills taken by mouth on improvement in urinary symptoms in women with urge incontinence or overactive bladder. Participation will last six to 12 months.

Many women experience accidental loss of urine called urge incontinence or overactive bladder (OAB). Women describe this as a sudden, strong desire to pass urine that results in leakage before reaching the toilet. Doctors refer to this as detrusor overactivity incontinence. The detrusor muscle is the bladder muscle that contracts to empty the bladder.

In this research study, we will compare how useful Botox injections and bladder medications are in treating overactive bladder symptoms. The bladder medications used in this study have been approved by the FDA (Food and Drug Administration) to treat urge incontinence. While Botox has been approved by the FDA to treat conditions like spastic muscles and wrinkles, it is still considered experimental for treating urge incontinence. Preliminary evidence suggests that it can be helpful.

In this study, all women will undergo injection of study medication (either Botox or placebo) into the bladder muscle through a cystoscope (a thin telescope) into the bladder AND all women will take either active anticholinergic bladder medications or placebo. A placebo is a pill or liquid that looks just like the real medicine, but has no actual medication in it. ALL women in this study will receive active treatment (that is, either Botox or real bladder medication) as well as a placebo. All treatments provided during the course of this study are at no charge to the participants.

Efficacy and impact of Botulinum Toxin A versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence

Sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who is eligible for this study?

Women who report symptoms of urge incontinence or overactive bladder (OAB)

• are 21 years of age or older
• experience this leakage two or more times per day
• may have tried other treatments for OAB including anticholinergic medication

Why is this study important?

Many women experience accidental loss of urine called urge incontinence or overactive bladder (OAB).  Women describe this as a sudden, strong desire to pass urine that results in leakage before reaching the toilet.  Doctors refer to this as detrusor overactivity incontinence.  The detrusor muscle is a bladder muscle that contracts to empty the bladder.   In this study the medication Botox will be studied to see if it is useful in treating overactive bladder symptoms.  The use of Botox is approved by the FDA (Food and Drug Administration) to treat things like spastic muscles and wrinkles.  However, in this study the use of Botox is experimental; that is, it is being used in a research study.  The study involves injection of study medication into the bladder muscle through a cystoscope (a thin telescope) into the bladder.

What will I be asked to do?

Bladder testing evaluation will be required prior to study enrollment.  A physical examination and some routine clinical tests will also be performed.  Participants will complete a voiding diary and a quality-of-life questionnaire to confirm final eligibility. If they are eligible, they will then be randomly assigned, like a flip of the coin, to either receive Botox or an anticholinergic.  Monthly clinic visits or telephone call evaluations will be done for up to a year following the injection. During participation in the study, monthly voiding diaries and three quality of life interviews are completed.

What will happen to the information that is collected about participants?

All of the information that the research staff collect about a participant in this study will be treated in a confidential (private) manner.  Only a special number that is assigned to the participant (and not her name) will appear on the study forms, which are used to collect information for the study and develop reports. 

If you would like more information about the ABC study please contact the site nearest you. A list of sites can be found at http://pfdn.org/current/abc.html.