ROSETTA Urinary Marker (RUM) Study

The purpose of this study is to characterize and evaluate the impact of 2 different treatment modalities (Interstim® and Botox A®) for refractory urgency urinary incontinence (UUI) on bladder inflammation and tissue remodeling manifested via biomarkers present in urine. Intra-detrusor Botox injections and sacral neuromodulation (SNM) have been shown to significantly improve symptoms of UUI. Based on published research data, both treatment modalities will likely result in the modulation of inflammatory mediators and markers of connective tissue remodeling that are associated with the pathophysiology of UUI.

The overall goal of this supplementary study is to investigate whether biological markers including those related to inflammation and connective tissue remodeling change following treatments with Botox A® and Interstim®.
The study will evaluate the baseline levels of biomarkers in urine of patients with refractory UUI and changes associated with response to therapy which may be indicative of differential effects to the 2 treatments. In addition, the study will characterize the pathophysiologic processes associated with UUI (pre- and post-treatment) and provide valuable information on the prognosis of therapeutic success/failure.

The levels of biomarkers in patients with UUI at baseline and in response to treatment will be compared to those in subjects without lower urinary tract symptoms (control group) over a similar period of time. Additional effort will be undertaken to characterize cell populations present in the urine of enrolled patients.