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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Maastricht University

Maastricht, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AHLeveeS System

Device

AHLeveeS System for treatment of overactive bladder

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

Sponsors and collaborators

Lead sponsor

Neuspera Medical, Inc.

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Aug 22, 2018
Registry last updated: Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed