N39.3
Conditions
Interventions
Group 1: Use of ACTICORE1® according to training program 6 minutes daily for 12 weeks + standard of care according to S2k-guideline "Diagnosis and Therapy of Female Urinary Incontinence"
Group 2: Stan
Sponsors
ACTICORE GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients with non-binary gender identity with stress incontinence * Age: 18 years * 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
Exclusion criteria
Exclusion criteria: -newly initiated pharmacological or physical therapy for the treatment of micturition symptoms (biofeedback, electrical stimulation) within the last four weeks -morbid obesity (BMI > 35 kg/m²) -any previous use of the ACTICORE1® intervention -inability to understand the content and scope of the study -cognitive impairment or psychiatric disorders -dementia -refusal of study participation by the patient -pregnancy (explicit inquiry during the study information process) -use of another pelvic floor training app (at inclusion and continuously during the study) -participation in another clinical trial aimed at improving continence -employees of ACTICORE AG / ACTICORE GmbH or any other institution involved in the conduct/ organization/ coordination/ funding of the study -previous surgery involving the sphincter muscle region (musculus levator ani) -anticipated / scheduled pelvic surgical procedures (including laser therapy) -patients after surgical procedures and/or laser therapy for improvement of continence -vulvodynia -spinal cord injury symptoms due to traumatic injury of the nerves and spinal cord at cervical, thoracic, lumbar, and sacral levels -congenital spinal cord injury symptoms -ASA score IV and V -pelvic organ prolapse -hormone therapy or gender reassignment -permanent urinary bladder catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the number of urinary incontinence episodes by at least 40% compared with baseline (bladder diary) | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of urinary incontinence (ICIQ-UI SF) after 4/8/12 weeks Quality of life (ICIQ-LUTSqol) after 4/8/12 weeks Change in symptoms assessed using the PGI-I after 4/8/12 weeks Average number of pads used, assessed using a bladder diary after 12 weeks | — |
Countries
Germany
Contacts
Public ContactAndreas Wiedemann
Universität Witten/Herdecke
Outcome results
None listed