Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

Inclusion Criteria:

• Female aged 18 years old or older

• Capable of understanding the clinical study procedures and giving informed consent

• Willing and able to undergo the study procedure

• Diagnosis of SUI or stress predominant mixed incontinence, for at least 6 months

• Provided authorization to use and disclose information for research purposes

Exclusion Criteria:

• Predominant urge incontinence per patient report or medical record

• Active symptomatic uncontrolled bladder instability as determined by theinvestigator

• Regularly or intermittently used a urethral catheter

• Active bladder cancer (currently undergoing or scheduled to undergo treatment forbladder cancer).

• Previous radiation treatment in the pelvic floor

• History or symptoms of cystocele, enterocele or rectocele of grade 3 or 4. Per themedical record or as determined by the investigator

• Current infection (urethritis, cystitis or vaginitis) as determined by investigator.

• Active herpes genitalis

• Unevaluated hematuria

• Currently taking, or has taken within 4 weeks prior to the screening/baseline visit,pharmacological treatment for SUI (including but not limited to, alpha adrenergics,and tricyclic antidepressants)

• Severe or uncontrolled diabetes, (defined as being a diabetic with a hemoglobin A1cof ≥10%) per patient medical record.

• History of drug/alcohol abuse, mental dysfunction, or other factors limiting herability to cooperate fully

• Pregnancy test with positive result during screening or women who are breastfeeding

• Women who are pregnant and/or have given birth in the previous 12 months

• Have implanted active neurostimulators, pacemakers, or defibrillators;neurostimulators which are passive or that can be briefly turned off for thestimulation procedure are acceptable

• Known systemic neurological dysfunctions

• Severe coagulation disorders

• Medically unstable at time of study and unsafe to undergo urodynamic testing (UDT)as determined by the investigator

• Presence of an artificial urinary sphincter

• Any medical condition (e.g. Multiple Sclerosis, spinal cord injury, mobility) oruncontrolled chronic disease (e.g. renal diseases that requires dialysis) that wouldinterfere with the patient's ability to comply with the protocol and/or may affectthe outcome of this study or safety of the subject as determined by the investigator