New Study Shows Popular Drugs Are No Match For
Biofeedback in Treatment of Overactive Bladder
Reviewed: Rodney A. Appell, MD; Peter Sand, MD; Roger Dmochowski, MD; Rodney Anderson, MD; Norman Zinner, MD; Daniel Lama, MD; Martha Roach, MD; John Miklos, MD; Daniel Saltzetein, MD; Timothy Boone, MD; David R. Staskin, MD; and Detlef Albrecht, MD, for the OBJECT Study Group.
Prospective Randomized Controlled Trial of Extended-Release Oxybutynin Chloride and Tolterodine Tartrate in the Treatment of Overactive Bladder: Results of the OBJECT Study. Mayo Clin Proc. 2001; 76:358-363.
By John D. Perry, PhD, Webmaster www.IncontiNet.com
A major multi-center research study shows that neither Extended-Release Oxybutynin Chloride nor Tolterodine Tartrate come close to the effectiveness of one or two sessions of Biofeedback in the treatment of Overactive Bladder.
In this study, 332 patients completed a double-blinded 12 week course of treatment. Slightly better results were obtained for the time-release drug than the regular doze; a 75% reduction in incontinence episodes compared with a 65% reduction. But in Burgio’s famous JAMA study, Biofeedback and behavioral treatment obtained an 81% reduction, in only 8 weeks time. In the same study, regular oxybutynin chloride came in at 69% reduction in leakage episodes. The Burgio study included 197 subjects.
The new study also revealed that neither formulation had a statistical advantage over the other on the all-important issue of side effects. 52% of the oxybutynin patients and 64% of the tolterodine patients experienced dry mouth, and 15% vs. 17% had headaches. None of these side effects were reported in Burgio’s biofeedback study.
Despite the moderate overall reduction in incontinence episodes, it should be noted that the average subject in both groups remained incontinent at the end of the study. The oxybutynin group had just over 1 accident per day, while the tolterodine group averaged 1.3 episodes per day.
Frequency episodes were equally disappointing. The oxybutynin group went from a mean of 13 voids a day before to 9.6 a day after treatment, while the other group went from 13 a day to 10.2 a day. ICS standards consider 8 voids a day and above to be incontinent.
It should be noted that Burgio achieved the 81% symptom reduction rate using a minimal amount of biofeedback — only one or two sessions — plus standard behavioral instructions. Other smaller studies using more biofeedback — as many as 120 sessions using home trainers — have achieved even higher success rates, but none have been as well documented nor prestigiously published as Burgio’s. The Appell et al study did not compare either drug to biofeedback, despite its superior track record.