A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder

• Baseline Period

o The baseline period will allow for washout of any medication affecting bladder function and to allow subject to begin her voiding diary.

• Prospective data collection will take place in the form voiding diary. Leak frequency, and other relevant parameters will be collected.
• Inclusion/exclusion criteria will be rechecked at end of baseline.
• Qol questionnaires will be completed in the office at the end of baseline period.
• Evaluation Period

o During the evaluation period, the subjects will use the ParaPatch System.

• No medications affecting bladder function will be allowed during the evaluation period.
• Subjects will complete voiding diaries, during the evaluation period. Data capture to include: adverse events, medication use, leak frequency and other relevant parameters.
• Qol questionnaires will be completed in the office at the end of evaluation period.
• Follow-up Period

o Subjects will be followed for after the evaluation period to check for residual Adverse Events.

• No medications affecting bladder function will be allowed during the follow-up period.
• Subjects will be called by the clinical coordinator at the end of the Follow-up period and asked about potential Adverse Events.