Prospective, multicenter, randomized, controlled, single-blind other clinical trial. What is the efficacy of pelvic floor biofeedback training with ACTICORE1® for stress incontinence?
- Conditions
- N39.3Stress incontinence
- Registration Number
- DRKS00027319
- Lead Sponsor
- ACTICORE GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 124
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.
- 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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ICIQ-Score after 16 weeks
- Secondary Outcome Measures
Name Time Method Quality of life (King's Health questionnaire) 0 / 8 / 16 / 52 after study inclusion.<br><br>Reduction in stress incontinence (ICIQ-UI-SF score)<br>0 / 8 / 52 after study inclusion<br><br>Adherence weekly questioning, on how many days<br>was exercised according to the recommendation