DRKS00033971
Not yet recruiting
未知
Prospective, multicenter, randomized, controlled, single-blind other clinical trial. What is the efficacy of app-based biofeedback training with ACTICORE1® for female stress incontinence? - ACU-3-trial
ACTICORE GmbH0 sites262 target enrollmentApril 4, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- N39.3
- Sponsor
- ACTICORE GmbH
- Enrollment
- 262
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* Patients with non\-binary gender identity with stress incontinence
- •\* Age: 18 years
- •\* ICIQ\-UI SF Score \> 5:
- •\* Frequency of urinary incontinence episodes per day (average)
- •\* Women who are able to calibrate the ACTICORE1 SensorSeat by contracting their pelvic floor as specified (lifting) by the ACTICORE1 app
- •\* Smartphone/tablet for using the ACTICORE1 app with sufficient hardware and software compatibility available
- •\* Ability to use the ACTICORE1 app, e.g. downloading the app, Bluetooth pairing of the ACTICORE1 app and ACTICORE1 SensorSeat
- •\* Valid private electronic address
- •\* Internet access available daily
- •\* Willingness to create a user profile in the ACTICORE1 app
Exclusion Criteria
- •\* newly started drug therapy for urinary incontinence
- •\* implementation of pelvic floor therapy
- •\* any previous use of the ACTICORE1® intervention
- •\* use of another app for pelvic floor training
- •\* inability to understand the content and extent of the study
- •\* cognitive deficits or psychiatric illnesses
- •\* dementia
- •\* refusal of participation in the study by the patient
- •\* pregnancy
- •\* participation in another clinical study to improve continence
Outcomes
Primary Outcomes
Not specified
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