Prospective, multicenter, randomized, controlled, single-blind other clinical trial. What is the efficacy of app-based biofeedback training with ACTICORE1® for female stress incontinence?
- Conditions
- N39.3Stress incontinence
- Registration Number
- DRKS00033971
- Lead Sponsor
- ACTICORE GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 262
* 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
* Resident in Germany
* Ability to use the German To read and understand language
* Treatment request
* 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
* employees of ACTICORE AG / ACTICORE GmbH or another institution involved in the implementation/organization/coordination/financing of the study
* previous operations in the area of ??the sphincter (levator ani muscle)
* expected/scheduled pelvic surgical interventions (including laser therapy),
* patients after surgical interventions and/or laser therapy to improve continence
* vulvodynia
* paraplegia due to traumatic injuries to the nerves and spinal cord in cervical, thoracic, lumbar and sacral level
* congenital paraplegia
* ASA score IV and V
* organ prolapse
* hormone therapy or gender reassignment
* permanent bladder catheter
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ICIQ-UI-SF-Score after 12 weeks<br>Quality of life (ICIQ-LUTSqol) 12 weeks after study inclusion.
- Secondary Outcome Measures
Name Time Method Change in symptoms, recorded using PGI-I,<br><br>Average number of urinary incontinence episodes, recorded using bladder diary<br><br>Average number of pads used, recorded using bladder diary