User Evaluation in Healthy Volunteers to Verify no Pelvic Floor Contraction is Stimulated When the Modified Neurotech Vital Device is Used Compared to the Neurotech Vital Device

Exclusion Criteria

• •Subjects who meet any of the following criteria will be excluded from participation in the study.
• •* Subjects who have an existing medical condition that would compromise their participation in the study.
• •* Subjects who have a physical condition that would make them unable to perform the study procedures.
• •* Subjects with a history of any respiratory condition including a chronic cough.
• •* Subjects with a history of an underlying neurological condition.
• •* Subjects with a history of low back pain involving the spinal nerve root.
• •* Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
• •* Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy.
• •* Subjects with a clinical diagnosis of prolapse greater than Stage 2.
• •* Subjects who are pregnant or could be pregnant.
• •* Subjects who are less than 6 months post-partum or who are lactating.
• •* Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
• •* Subjects with pelvic pain or fibromyalgia or paravaginal defect.
• •* Subjects with an active implanted medical device (ie pacemaker, pump etc).
• •* Subjects with a history of heart disease or stroke.
• •* Subjects with a known cancer.
• •* Subjects with an injury or disability affecting any part of their body which will be in contact with the garment.
• •* Subjects who are currently involved in any injury litigation claims.
• •* Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
• •* Subjects who have participated in a clinical study in the last 3 months.