N30.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Interstiial cystitis (IC/BPS) ESSIC 2+3
Exclusion criteria
Exclusion criteria: - Change in therapy in the last 3 weeks before inclusion in the study - Patients who are not capable of giving their own consent - Patients who are physically or mentally unable to use the device themselves - Patients with cardiac pacemakers, defibrillators or other active implants - Patients with magnetic implants (implants not compatible with MRI) - Patients receiving corticosteroid injections - Patients in pregnancy and lactation - Patients with tumor diseases - Patients with a tendency to bleed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the Global Response Assessment (GRA) compared to real and sham stimulation after 84 days of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of verum/sham stimulation relative to baseline after 84 days of treatment with PEMF: - Reduction of pain measured with NRS (Numerical Rating Scale 0-10), Deutscher Schmerzfragebogen, Pain Detect and BPIC-SS (Bladder Pain/Interstitial Cystitis Symptom Score). - Reduction of the urge to urinate measured with BPIC-SS and OAB-q SF (OverActive Bladder questionnaire Short Form) - Reduction of the feeling of pressure in the bladder measured with BPIC-SS. - Reduction of micturition frequency during the day and at night via a micturition protocol. - Increase in functional bladder capacity measured for 3 days (at the weekend) before inclusion in the study and 3 days at the end of the intervention after 79 to 82 days (at the weekend) with a voiding protocol. - Improvement in quality of life measured by OAB-q SF and BPIC-SS. Comparison of verum/sham stimulation relative to baseline after 28 days of treatment with PEMF | — |
Countries
Germany
Contacts
Städtisches Klinikum Lüneburg