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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643380
• Other study ID #: NSM-001
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: August 2018
• Source: Neuspera Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 30, 2018
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Device:
• AHLeveeS System
AHLeveeS System for treatment of overactive bladder

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Neuspera Medical, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sacral Nerve Response measured by observed bellow response and big toe flexion	Stimulation of the S3 sacral nerve measured by observed bellows response and big toe flexion	Procedure
Primary	AHLeveeS System placement in the S3 foramen assessed by fluoroscopy image	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	Procedure