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

Neuspera Medical, Inc.1 site in 1 country6 target enrollmentAugust 17, 2017

ConditionsOveractive Bladder

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Overactive Bladder
Sponsor: Neuspera Medical, Inc.
Enrollment: 6
Locations: 1
Primary Endpoint: Sacral Nerve Response measured by observed bellow response and big toe flexion
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 17, 2017

End Date

January 30, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Neuspera Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sacral Nerve Response measured by observed bellow response and big toe flexion

Time Frame: Procedure

Stimulation of the S3 sacral nerve measured by observed bellows response and big toe flexion

AHLeveeS System placement in the S3 foramen assessed by fluoroscopy image

Time Frame: Procedure

Confirm that the AHLeveeS System can be correctly placed and inserted in close proximity of the sacral nerve in the S3 foramina assessed by fluoroscopy image