NCT03643380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

July 13, 2018

Last Update Submit

August 20, 2018

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Investigational SNS device

EXPERIMENTAL
Device: AHLeveeS System

Interventions

AHLeveeS SystemDEVICE

AHLeveeS System for treatment of overactive bladder

Investigational SNS device

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gommert A. van Koeveringe

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2018

First Posted

August 22, 2018

Study Start

August 17, 2017

Primary Completion

November 15, 2017

Study Completion

January 30, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)