What is the benefit of biofeedback training of the pelvic floor with ACTICORE1® for urinary incontinence?

What is the benefit of biofeedback training of the pelvic floor with ACTICORE1® for urinary incontinence? - ACU Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024913

Enrollment

Registered

2021-03-31

Start date

2021-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N39.3 N39.4

Interventions

Group 1: Biofeedback training with the ACTICORE1 6 minutes a day after inclusion in the study Group 2: Biofeedback training with the ACTICORE1 6 minutes a day for 12 weeks after inclusion in the study

Eligibility

Sex/Gender

All

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: All urinary incontinent patients with subjective impairment and an ICIQ score of greater than or equal to 5 - Vulnerable individuals are also included: Patients with mental illnesses, People with illnesses or disabilities that impair their ability to understand and / or significantly impair their ability to cope with everyday life; pregnant women, patients under 18 years of age (2-11, 12-17) and> 65 years of age signed informed consent

Exclusion criteria

Exclusion criteria: Understanding of the patient's participation in the study - Vulvodynia - Paraplegic symptoms include traumatic injuries to the nerves and the spinal cord at the cervical, thoracic, lumbar and sacral levels - Congenital paraplegic symptoms

Design outcomes

Primary

Measure	Time frame
ICIQ-Score 12 weeks after study enrollment	—

Secondary

Measure	Time frame
Quality of life according to the EQ-5D-3L questionnaire 4 weeks after enrollment Feeling of prolapse 4 weeks after inclusion in the study Impairment of sexuality due to incontinence (VAS) 4 weeks after inclusion in the study Wearing a diaper (yes / no) 4 weeks after enrollment Quality of life according to the EQ-5D-3L questionnaire 8 weeks after inclusion in the study Feeling of prolapse 8 weeks after inclusion in the study Impairment of sexuality by the Incontinence (VAS) 8 weeks after Study inclusion Wearing a diaper (yes / no) 8 weeks after enrollment in the course Quality of life according to the EQ-5D-3L questionnaire 12 weeks after inclusion in the study Feeling of prolapse 12 weeks after inclusion in the study Impairment of sexuality due to incontinence (VAS) 12 weeks after inclusion in the study Wearing a diaper (yes / no) 12 weeks after enrollment ICIQ-Score 365 days after study enrollment Quality of life according to the EQ-5D-3L questionnaire 365 days after inclusion in the study Feeling of prolapse 365 days after inclusion in the study Impairment of sexuality due to incontinence (VAS) 365 days after inclusion in the study Wearing a diaper (yes / no) 365 days after enrollment	—

Measure

Time frame

Quality of life according to the EQ-5D-3L questionnaire 4 weeks after enrollment Feeling of prolapse 4 weeks after inclusion in the study Impairment of sexuality due to incontinence (VAS) 4 weeks after inclusion in the study Wearing a diaper (yes / no) 4 weeks after enrollment Quality of life according to the EQ-5D-3L questionnaire 8 weeks after inclusion in the study Feeling of prolapse 8 weeks after inclusion in the study Impairment of sexuality by the Incontinence (VAS) 8 weeks after Study inclusion Wearing a diaper (yes / no) 8 weeks after enrollment in the course Quality of life according to the EQ-5D-3L questionnaire 12 weeks after inclusion in the study Feeling of prolapse 12 weeks after inclusion in the study Impairment of sexuality due to incontinence (VAS) 12 weeks after inclusion in the study Wearing a diaper (yes / no) 12 weeks after enrollment ICIQ-Score 365 days after study enrollment Quality of life according to the EQ-5D-3L questionnaire 365 days after inclusion in the study Feeling of prolapse 365 days after inclusion in the study Impairment of sexuality due to incontinence (VAS) 365 days after inclusion in the study Wearing a diaper (yes / no) 365 days after enrollment

—

Countries

Germany

Contacts

Public ContactChristoph Paasch

Universitätsklinikum Brandenburg an der Havel

paasch.mhb@klinikum-brandenburg.de+493381411249

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026