Augmenting Urinary Reflex Activity: Study 3

N/AActive Not RecruitingNCT06597994

Amber Therapeutics Ltd12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Incontinence

Interventions

Amber UI systemDEVICE

Upgrade of Amber UI system recharge accessories and system firmware

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Participant has withdrawn from AURA-2 clinical investigation.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).

Locations (1)

University Hospital Antwerp

Antwerp, Belgium

Outcomes

Primary Outcomes

Change in absolute recharge performance

Change in perceived recharge usability before and after receiving new recharge accessories and training.

Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

Change in relative recharge performance

Relative (percentage) change in frequency and duration of recharging sessions after receiving new recharge accessories and training compared to baseline.

Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

Secondary Outcomes

Change in recharge usability

% of time the device is fully operational and available for use after receiving new recharge accessories and training compared to baseline

Time frame: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months

Fully adaptive mode usability

Change in frequency, severity and impact on quality of life of urinary incontinence episodes as assessed by Short Form version of the International Consultation on Incontinence urinary questionnaire (ICIQ-UI SF) after receiving fully adaptive firmware update and training compared to baseline. The ICIQ-UI SF is a 4 item simple questionnaire with minimum value of 0 and maximum value of 21 with higher scores indicating higher severity of UI symptoms and their impact on health-related quality of life.

Time frame: 48 hours; 2 months; 8 months

Fully adaptive mode specificity

Change in quality of life in relation to change in obstructive symptoms, irritative symptoms and stress symptoms as assessed by the Long Form version of the Urogenital Distress Inventory (UDI-LF) after receiving fully adaptive firmware update and training compared to baseline. The UDI-LF consists of 19 questions and total scores are converted to a score range of 0-300, with higher scores representing greater symptom distress.

Data from ClinicalTrials.gov

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