1. Home
  2. Approved trials
  3. » فارسی

Effectiveness of modulated extremely low frequency electromagnetic fields compared to placebo in the management of Chronic drug-resistant E. Coli-induced cystitis

Protocol summary

Study aim
To investigate the effectiveness of extremely low frequencies (ELF) electromagnetic fields in the treatment of drug-resistant E. Coli-induced chronic bacterial cystitis.
Design
Two-arm, parallel group, double blind randomized controlled clinical trial
Settings and conduct
The study will be conducted in ID MEDICALS Moretti Roma, Italy
Participants/Inclusion and exclusion criteria
Women, age 18 to 80 years, suffering from chronic E-coli indued drug-resistant cystitis will be recruited. Women with serious co-morbid conditions will be excluded.
Intervention groups
Experimental 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.
Main outcome variables
All participants will be tested for IL-6 and D-dimer (from a complete blood count), urine analysis (pH, specific gravity, urobilinogen, red blood cells, and leukocytes), and urine culture, detecting E. coli at levels greater than 100,000 CFU/ml.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211022052833N3
Registration date: 2024-02-09, 1402/11/20
Registration timing: prospective

Last update: 2024-02-09, 1402/11/20
Update count: 0
Registration date
2024-02-09, 1402/11/20
Registrant information
Name
Aatik Arsh
Name of organization / entity
Khyber Medical University
Country
Pakistan
Phone
+92 937 576111
Email address
aatikarsh@kmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-15, 1402/11/26
Expected recruitment end date
2024-05-15, 1403/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of modulated extremely low frequency electromagnetic fields compared to placebo in the management of Chronic drug-resistant E. Coli-induced cystitis
Public title
Electromagnetic fields for drug-resistant cystitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
History of myocardial infarction Stroke Uncontrolled diabetes Cancer Allergic skin reactions Any other condition that can affect participation in the trial
Age
From 18 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 148
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Board, ID MEDICALS
Street address
2nd Floor, ID Medicals Building, Viale L. Moretti 12, 00163 Roma, Italy
City
Moretti
Postal code
00163
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
DIR/ID Medicals-EB/2401

Health conditions studied

1

Description of health condition studied
Chronic drug-resistant E. Coli cystitis
ICD-10 code
N30.1
ICD-10 code description
Interstitial cystitis (chronic)

Primary outcomes

1

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
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).
Category
Treatment - Devices

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
ID MEDICALS
Full name of responsible person
Ivan D’Agostino
Street address
viale L. Moretti 12, 00163 Roma, ITALY
City
Moretti
Postal code
00163
Phone
+39 388 697 1279
Email
drivandagostino@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
CRESO S.r.l.
Full name of responsible person
Fabiola Marelli
Street address
CRESO S.r.l., via M. Masia 79, 22100 Como, ITALY.
City
Masia
Postal code
22100
Phone
+39 335 768 0033
Email
amministrazione@osteopatiacreso.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CRESO S.r.l.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
ID Medical
Full name of responsible person
Ivan D'Agostino
Position
Health specialist
Latest degree
Ph.D.
Other areas of specialty/work
Advanced Biophysical Medicine
Street address
Viale L. Moretti 12, 00163 Roma, Italy
City
Moretti
Province
Rome
Postal code
00163
Phone
+39 388 697 1279
Email
drivandagostino@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
ID Medical
Full name of responsible person
Ivan D'Agostino
Position
Health specialist
Latest degree
Ph.D.
Other areas of specialty/work
Advanced Biophysical Medicine
Street address
Viale L. Moretti 12, 00163 Roma, Italy
City
Moretti
Province
Rome
Postal code
00163
Phone
+39 388 697 1279
Email
drivandagostino@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
ID Medical
Full name of responsible person
Ivan D'Agostino
Position
Health specialist
Latest degree
Ph.D.
Other areas of specialty/work
Advanced Biophysical Medicine
Street address
Viale L. Moretti 12, 00163 Roma, Italy
City
Moretti
Province
Rome
Postal code
00163
Phone
+39 388 697 1279
Email
drivandagostino@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data and documents
When the data will become available and for how long
After the trial completion, anonymized data will be available.
To whom data/document is available
Anonymized data will be available for researchers who show interest to further analyze or use the data.
Under which criteria data/document could be used
Trial manager will have the data/document available and he will share it upon a reasonable request.
From where data/document is obtainable
It can be obtained from Trial manager upon a reasonable request.
What processes are involved for a request to access data/document
Email to trial manager
Comments
Loading...