Prospective, multicenter, randomized, controlled, single-blind other clinical trial. "What is the efficacy of pelvic floor biofeedback training with ACTICORE1® for stress incontinence?"

Prospective, multicenter, randomized, controlled, single-blind other clinical trial. "What is the efficacy of pelvic floor biofeedback training with ACTICORE1® for stress incontinence?" - ACU-II-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027319

Enrollment

124

Registered

2022-01-19

Start date

2022-07-10

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

Interventions

Group 1: Use of ACTICORE1® according to training program 6 minutes daily for 16 weeks. Group 2: Recommendation for the implementation of pelvic floor training according to German supply reality (home

Eligibility

Sex/Gender

Female

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Stress incontinence with subjective impairment and an ICIQ score of greater 6 - Women who can contract their BB at will with an Oxford grading "standing" of of at least 2. - Women and men over the age of 65 are also included as vulnerable individuals. Availability of a smartphone/tablet, ability to operate same e.g. download app, Pairing smartphone sensor - Internet access available on a daily basis - Creation of a user profile in the ACTICORE1 app.

Exclusion criteria

Exclusion criteria: - Patient refusal to participate in the study - Pregnancy - Inability to understand the content and scope of the study - vulvodynia - Paraplegic symptoms due to traumatic injuries to the nerves and spinal cord at the cervical, thoracic, lumbar and sacral levels. - Congenital paraplegia symptomatology - Patients with sacral, perianal open secretory wounds following rectal and rectal resection and amputation. rectal resection and amputations - ICQ score less than 5 - ASA score IV and V - Oxford grading 0 and 1 (standing) (principle contractility of the pelvic floor for the ACTICORE use required)

Design outcomes

Primary

Measure	Time frame
ICIQ-Score after 16 weeks	—

Secondary

Measure	Time frame
Quality of life (King's Health questionnaire) 0 / 8 / 16 / 52 after study inclusion. Reduction in stress incontinence (ICIQ-UI-SF score) 0 / 8 / 52 after study inclusion Adherence weekly questioning, on how many days was exercised according to the recommendation	—

Countries

Germany

Contacts

Public ContactChristoph Paasch

Oberarzt in der Klinik für Allgemein- und ViszeralchirurgieUniversitätsklinikum Brandenburg an der HavelMedizinische Hochschule Brandenburg

paasch.mhb@klinikum-brandenburg.de+49 3381 411200

Outcome results

None listed

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