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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amber UI Therapy | Experimental | Participants will receive optimised recharge accessories and device firmware upgrades |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amber UI system | Device | Upgrade of Amber UI system recharge accessories and system firmware |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in absolute recharge performance | Change in perceived recharge usability before and after receiving new recharge accessories and training. | 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. | 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months |
| Fully adaptive mode usability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan De Wachter, MD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Single Group Assignment
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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. |
| 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. | 48 hours; 2 months; 8 months |
| Adverse Device Events | Incidence of adverse events as defined by REGULATION (EU) 2017/745(MDR) and MDCG 2020-10/1 | 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |