Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence

Acute Study to Evaluate a Novel Implantable Midfield Powered Device in Humans With Urinary Incontinence

A pre-market, prospective, non-randomized acute feasibility study for the treatment of patients with urinary incontinence (UI) as a consequence of urinary incontinence.

Inclusion Criteria:

• Subject was eligible for treatment and indication for the Medtronic InterStim system or InterStim II
• Subject wished to undergo an InterStim or InterStim II implant procedure after this acute clinical investigation
• Subject was in good health in the opinion of the investigator
• Subject was able to understand and voluntarily signed and dated the Ethics Committee approved informed consent form prior to initiation of any screening or study-specific procedures
• Subject was minimum of 18 years and maximum of 65 years of age

Exclusion Criteria:

- Subject had any of the contraindications for the InterStim system or InterStim II system