Feasibility Study Evaluating the ParaPatch System

• 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.

Inclusion criteria

• Women aged from >18 to < 75 years old.
• Subject has the ability to read and comprehend English, and to reliably record information as required by the Protocol, including the proper completion of the questionnaires.
• Subject is able to provide written informed consent prior to participation in the study.
• Diagnosed with either of the following: a) overactive bladder, or b) urinary stress incontinence.

Exclusion criteria

• Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
• Subject has demonstrated or is believed to be at risk of non-compliance with study procedures (e.g., for completing the diary or returning for required follow-up visits).
• Subject has undergone onabotulinumtoxin-A injections of the bladder in the last twelve (12) months.
• Subject is not suitable for the study for any reason (including overall health, pre-existing conditions or medications) in the judgment of the investigator.
• Have an untreated recurrent urinary tract infection (> 2 times within the past 6 months).
• Have neurogenic disorders such as Multiple Sclerosis, ALS, or Parkinson s Disease.
• Patients with a diagnosis of painful bladder syndrome, other pelvic pain or interstitial cystitis.