NCT02781636

Brief Summary

30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

May 20, 2016

Last Update Submit

September 4, 2020

Conditions

Urge Incontinence

Keywords

EfficacyImplantableWirelessNeuromodulationDeviceTibial

Outcome Measures

Primary Outcomes (1)

  • Reduction in Urge Incontinence Episodes

    90 days

Study Arms (1)

Chronic Tibial Implant Arm

EXPERIMENTAL

StimGuard Protect System (Chronic Tibial Nerve Stimulation) Implant Procedure. Lead implanted adjacent to tibial nerve. Wireless rechargeable system.

Device: Device: StimGuard Protect System

Interventions

Device: StimGuard Protect SystemDEVICE

Lead implanted adjacent to tibial nerve. Wireless rechargeable system.

Also known as: Chronic Afferent Nerve Stimulation
Chronic Tibial Implant Arm

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of overactive bladder with urgency urinary incontinence

You may not qualify if:

  • Primary complaint of stress urinary incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZA

Edegem, 2650, Belgium

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 24, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Upon Study Completion

Locations

BE(1)