Clinical effects of pulsed electromagnetic fields (PEMF) in patients with interstitial cystitis - a randomized controlled double-blind pilot stud

Not Applicable

Conditions: N30.1
Interstitial cystitis (chronic)

Registration Number: DRKS00030890

Lead Sponsor: Städtisches Klinikum Lüneburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 20

Inclusion Criteria

Interstiial cystitis (IC/BPS) ESSIC 2+3

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the Global Response Assessment (GRA) compared to real and sham stimulation after 84 days of treatment.

Secondary Outcome Measures

Name	Time	Method
Comparison of verum/sham stimulation relative to baseline after 84 days of treatment with PEMF: <br>- Reduction of pain measured with NRS (Numerical Rating Scale 0-10), Deutscher Schmerzfragebogen, Pain Detect and BPIC-SS (Bladder Pain/Interstitial Cystitis Symptom Score).<br>- Reduction of the urge to urinate measured with BPIC-SS and OAB-q SF (OverActive Bladder questionnaire Short Form)<br>- Reduction of the feeling of pressure in the bladder measured with BPIC-SS.<br>- Reduction of micturition frequency during the day and at night via a micturition protocol.<br>- 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.<br>- Improvement in quality of life measured by OAB-q SF and BPIC-SS.<br>Comparison of verum/sham stimulation relative to baseline after 28 days of treatment with PEMF