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IRCT20211022052833N3 IRCT 2024-02-09 CRESO S.r.l. Electromagnetic fields for drug-resistant cystitis Effectiveness of modulated extremely low frequency electromagnetic fields compared to placebo in the management of Chronic drug-resistant E. Coli-induced cystitis 2024-02-15 anticipated 148 Complete https://irct.ir/trial/75213 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization will be used in this study. Participants will distribute randomly into experimental (low frequencies electromagnetic field) and control (placebo) groups . This will be based on a computer-generated randomization schedule via open epi software (www.openepi.com) prepared before the study. Using software systems to define the intervention codes will dictate the group assignment for the participants, Blinding description: The proposed clinical trial will be double-blind and patients and assessors will be blind. The control group will receive a placebo. Placebo will be used by placing the applicators without emitting signals, thus patients will have no idea whether they are in the experimental group or control group. Assessors who will collect data at baseline and post-treatment will not be aware of treatment allocation and thus will remain blind. The assessors will not be provided with randomization codes. The blinding will be broken once all participants and data have been completed (under normal circumstances). In an emergency, the researcher can define the intervention by calling the software system responsible for breaking the intervention code. The entire randomization code will be revealed when the study is completed, and the database is closed. N/A Chronic drug-resistant E. Coli cystitis. Intervention 1: Intervention group: Experimental group will receive electromagnetic fields, modulated at extremely low frequencies . For treatment, a sequence of signals (BSB) will be created. In order to emit the BSB sequence, a PEMF ion resonance generator, Seqex (SISTEMI SRL) mod MED (compliant with Directive 93/42/EEC and standard EN 60601-1 regarding safety and essential performance, CE Certificate issued by Notified Body CE0051), will be used. This can write signal sequences, store them on a card, and emit them, emitting sequences from 1 to 80 Hz, with 30 waveforms, and signal intensity from 1 to 100 µT at the source. A total of 8 applications will be performed, twice a week with a 48-72 hour interval between each session (i.e., Monday and Thursday). Intervention 2: Control group: The control group will receive placebo. Placebo will be used by placing the applicators without emitting signals, thus patients will have no idea whether they are in the experimental group or control group. Yes - There is a plan to make this available What will be shared: Data and documents When: After the trial completion, anonymized data will be available. To whom: Anonymized data will be available for researchers who show interest to further analyze or use the data. Conditions: Trial manager will have the data/document available and he will share it upon a reasonable request. Where to obtain: It can be obtained from Trial manager upon a reasonable request. How to obtain: Email to trial manager Comments:
public Ivan D'Agostino
Viale L. Moretti 12, 00163 Roma, Italy
Moretti Italy 00163 +39 388 697 1279 drivandagostino@gmail.com ID Medical scientific Ivan D'Agostino
Viale L. Moretti 12, 00163 Roma, Italy
Moretti Italy 00163 +39 388 697 1279 drivandagostino@gmail.com ID Medical Italy Women, age 18 to 80 years, Women suffering from chronic E-coli indued drug-resistant cystitis. Chronic cystitis will be defined as at least 3 episodes of cystitis per year. The women with chronic cystitis will be labelled as drug-resistant if they have previously used six types of antibiotics (trimethoprim, nitrofurantoin, fluoroquinolones, sulfonamides, amoxicillin, and ampicillin) for at least 2 months without satisfactory clinical response. 18 years 80 years Female History of myocardial infarction Stroke Uncontrolled diabetes Cancer Allergic skin reactions Any other condition that can affect participation in the trial N30.1 Interstitial cystitis (chronic) Treatment - Devices Placebo Intervention group: Experimental group will receive electromagnetic fields, modulated at extremely low frequencies . For treatment, a sequence of signals (BSB) will be created. In order to emit the BSB sequence, a PEMF ion resonance generator, Seqex (SISTEMI SRL) mod MED (compliant with Directive 93/42/EEC and standard EN 60601-1 regarding safety and essential performance, CE Certificate issued by Notified Body CE0051), will be used. This can write signal sequences, store them on a card, and emit them, emitting sequences from 1 to 80 Hz, with 30 waveforms, and signal intensity from 1 to 100 µT at the source. A total of 8 applications will be performed, twice a week with a 48-72 hour interval between each session (i.e., Monday and Thursday). Control group: The control group will receive placebo. Placebo will be used by placing the applicators without emitting signals, thus patients will have no idea whether they are in the experimental group or control group. Detecting E. coli levels greater than 100,000 CFU/ml. Timepoint: Pre and post-treatment (1 month). Method of measurement: Urine analysis and Urine culture: Urine analysis will be conducted using refractometric and cytofluorimetric methods following SIBioC guidelines, and urine culture will be performed using a conventional method according to AMCLI and EUCAST guidelines. CRESO S.r.l. Approved 2024-01-10 Ethics Board, ID MEDICALS 2nd Floor, ID Medicals Building, Viale L. Moretti 12, 00163 Roma, Italy Moretti Rome Italy