Urinary Incontinence

Product Candidate Description

This is a combination of two molecules, both well known but neither previously used for this indication. Patients with a history of incontinence, whether stress, urge, or mixed, administer this formulation at decreasing frequencies as their condition resolves.

Laboratory Status

Work on this product has been restricted to the clinic. No significant lab work has been completed. Because of the nature of the molecules involved, lab efforts would be focused strictly on mechanism-of-action studies.

Clinical Status

A small, double-blind crossover study was conducted that clearly showed that each of the two components demonstrated some anti-incontinence activity, but that the combination was far superior to the single agents. Some of the treated patients have had no incontinence for years, even after years of daily accidents. Others must maintain reduced frequency of use of the product to maintain total bladder control.

Early experience with only a few patients suggested that this formulation might also be useful for the treatment of fecal incontinence. No adverse effects have been reported.

Path Forward

An IND application has been approved by the FDA. Laboratory studies will be conducted concurrent with the trial.