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

Neuspera Medical

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder

Treatments: Device: AHLeveeS System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03643380

NSM-001

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Investigational SNS device

Experimental group

Treatment:

Device: AHLeveeS System