The Anticholinergic vs. Botox Comparison (ABC) study is a randomized clinical trial being conducted collaboratively at 11 site locations for women who have urge incontinence (UI), but who do not have neurologic disease. UI is involuntary loss of urine while suddenly feeling the need or urge to urinate. The goal of the study is to compare the change in UI episodes over 6 months between women receiving a single injection of 100 units of botulinum toxin A (Botox A®) in muscles near the bladder plus daily oral placebo tablets versus women receiving a similar injection of saline plus daily anticholinergic therapy.
All participants receive one intra-detrusor injection and take a study tablet daily for six months. Because both study groups are masked and receive only one injection, a change in anticholinergic medication or dose escalation was allowed, with similar changes in the placebo drug dosing in the study group that received the Botox A® injection. The study is in the follow-up phase during which participants are followed for 6 months post study drug to determine duration of treatment effect. During the follow-up period no study intervention (i.e., medication or placebo tablets) is provided.
Participants complete baseline quality of life (QOL) measures and are scheduled for an injection visit. Prior to this visit, the coordinators provided the randomization number to their site’s investigational pharmacy, who prepared the injection and provided study medication. During the injection visit, participants receive study medication. The primary study outcome is change in the mean number of UI episodes from baseline during the 6-month double-blind period. This change is measured prospectively by having participants complete a 3-day diary every month during this 6-month time period. Participants are seen in clinic at 2-month intervals during which time a study nurse coordinator or member of the research staff administers the Patient Global Symptom Control (PGSC) rating scale and provides a 2-month supply of study medication.