Clinical effects of pulsed electromagnetic fields (PEMF) in patients with interstitial cystitis - a randomized controlled double-blind pilot stud
Organizational Data
- DRKS-ID:
- DRKS00030890
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2022-12-08
- Last update in DRKS:
- 2024-03-15
- Registration type:
- Prospective
Acronym/abbreviation of the study
PEMF-IC
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
The therapeutic effect of pulsating electromagnetic fields (PEMF) in interstitial cystitis is to be examined using a prospective, randomized, placebo-controlled, double-blind pilot study. The application of pulsating electromagnetic fields (PEMF) offers a therapeutic possibility to accelerate tissue regeneration, increase tissue blood flow, reduce pain and inflammation. PEMF is a non-invasive procedure. The palm-sized PEMF device is placed in the pelvic area. It emits electromagnetic fields of 4 different frequencies (Sequential Protocol Programming) in the low-frequency range (<150 Hz), which are run through in a cycle of 30 minutes.
Health condition or problem studied
- ICD10:
- N30.1 - Interstitial cystitis (chronic)
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- verum stimulation
- Arm 2:
- sham stimulation
Endpoints
- Primary outcome:
- Improvement in the Global Response Assessment (GRA) compared to real and sham stimulation after 84 days of treatment.
- Secondary outcome:
- 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
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Städtisches Klinikum Lüneburg Lüneburg
Recruitment period and number of participants
- Planned study start date:
- 2023-01-01
- Actual study start date:
- 2023-02-14
- Planned study completion date:
- 2024-03-11
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 20
- Final Sample Size:
- 20
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Städtisches Klinikum LüneburgDr. med. Björn Theodor KaftanBögelstrasse 121339 LüneburgGermany
- Telephone:
- +494131770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum-lueneburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Städtisches Klinikum LüneburgDr. med. Björn Theodor KaftanBögelstrasse 121339 LüneburgGermany
- Telephone:
- +494131770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Städtisches Klinikum LüneburgDr. med. Björn Theodor KaftanBögelstrasse 121339 LüneburgGermany
- Telephone:
- +494131770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Städtisches Klinikum LüneburgDr. med. Björn Theodor KaftanBögelstrasse 121339 LüneburgGermany
- Telephone:
- +494131770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Electro Zeutika GmbHBürgermeister-Jakob-Karg-Strasse 3385630 GrasbrunnGermany
- Telephone:
- +49 8106-377 89 35
- Fax:
- +49 8106-377 89 36
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.electro-zeutika.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am MenschenKarl-Wiechert-Allee 18-2230625 HannoverGermany
- Telephone:
- +49-511-3802208
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-11-08
- Ethics committee number:
- Bo/44/2022
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-11-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry