Augmenting Urinary Reflex Activity: Study 3 (AURA-3)

Amber Therapeutics

Status: Active, not recruiting

Conditions: Urinary Incontinence

Treatments: Device: Amber UI system

Study type: Interventional

Funder types: Industry

Identifiers

NCT06597994

TS-01388

Details and patient eligibility

About

AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has exited the AURA-2 clinical investigation.
• Participant has an implanted Amber UI system.
• Consents to participation.

Exclusion criteria

• Participant has withdrawn from AURA-2 clinical investigation.
• Participant is pregnant.
• A past or current condition that in the opinion of the PI contraindicates enrolment (PI discretion).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Amber UI Therapy

Experimental group

Description:

Participants will receive optimised recharge accessories and device firmware upgrades

Treatment:

Device: Amber UI system