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AURA-2: Augmenting Urinary Reflex Activity

NCT05241379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-08-12

No results posted yet for this study

Summary

AMBER AURA-2 study (Augmenting Urinary Reflex Activity 2) is a short-duration (6 month) safety and electrophysiological study using an implanted Amber UI system and two electrode leads to provide closed-loop pudendal nerve stimulation for the treatment of urinary incontinence.

Conditions

Interventions

DEVICE

Amber UI System

The implantable components of the Amber UI system consist of an implantable pulse generator (Picostim Amber IPG), 2 electrode leads with anchoring system

Sponsors & Collaborators

  • Amber Therapeutics Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2024-04-15
Completion
2024-04-15

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05241379 on ClinicalTrials.gov