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NCT06597994 | NOT YET RECRUITING | Urinary Incontinence

Augmenting Urinary Reflex Activity: Study 3
Sponsor:

Amber Therapeutics Ltd

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.

Condition or disease

Urinary Incontinence

Intervention/treatment

Amber UI system

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Therapy Optimisation Study of Adaptive Pudendal Neuromodulation in Women With Urinary Incontinence Implanted With the Amber UI System.
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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  • * Participant has withdrawn from AURA-2 clinical investigation.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).
Augmenting Urinary Reflex Activity: Study 3

Location Details

NCT06597994

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Belgium,

University Hospital Antwerp

Antwerp, Belgium, 2650