Urinary Incontinence
Conditions
Brief summary
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.
Interventions
DEVICEAmber UI system
Upgrade of Amber UI system recharge accessories and system firmware
Sponsors
Amber Therapeutics Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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* Participant has withdrawn from AURA-2 clinical investigation.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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in absolute recharge performance | 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months | Change in perceived recharge usability before and after receiving new recharge accessories and training. |
| Change in relative recharge performance | 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months | Relative (percentage) change in frequency and duration of recharging sessions after receiving new recharge accessories and training compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in recharge usability | 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months | % of time the device is fully operational and available for use after receiving new recharge accessories and training compared to baseline |
| Fully adaptive mode usability | 48 hours; 2 months; 8 months | 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. |
| Fully adaptive mode specificity | 48 hours; 2 months; 8 months | 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. |
| Adverse Device Events | 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months | Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1 |
Countries
Belgium
Outcome results
None listed