DRKS00027319
Completed
未知
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
ACTICORE GmbH0 sites124 target enrollmentJanuary 19, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- N39.3
- Sponsor
- ACTICORE GmbH
- Enrollment
- 124
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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