Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000118303
Ethics application status
Approved
Date submitted
24/11/2016
Date registered
23/01/2017
Date last updated
14/01/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of deep electromagnetic field stimulation of pelvic floor muscles in women
with symptoms of stress and mixed urinary incontinence
Scientific title
Assessment of deep electromagnetic field stimulation of pelvic floor muscles in women
with symptoms of stress and mixed urinary incontinence: a randomized, single blinded
study with a placebo group.
Secondary ID [1] 290617 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary incontinence 301117 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300890 300890 0 0
Physiotherapy
Renal and Urogenital 301134 301134 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention in group A will include local, 20-minute of DEMF stimulation, with electromagnetic induction of 2.5 T. In the stimulation the manually set mode, recommended by the manufacturer for individuals with symptoms of SUI and MUI will be used (the frequency of 10-50 Hz, pulse duration: 3 seconds (s), pause time: 6 s, the magnetic induction of 2.5 T). The intervention will be carried out in a comfortable and safe sitting position on a specialized chair, with the special generator placed inside the seat.
Intervention in group B will include the commonly used pulsed magnetic field. Stimulation will last 20 minutes (frequency: 10 to 50 Hz, Magnetic induction: 0.1 mT to 20 mT - at the discretion of the treating physician). The intervention will also be carried out in a comfortable, safe seating position on a specialized chair, with the field generator placed in the seat in the form of flat cushions.
For both groups, each participant receives a single treatment session.
Intervention code [1] 296490 0
Treatment: Devices
Comparator / control treatment
Group C will be a placebo group for this intervention. In order to exclude the effect of the impact of this device on the tissue, specialized overlay on the generator will be applied, which prevents the penetration of electromagnetic waves into the structures of pelvic floor. Participants will not be aware of which intervention they are receiving (single-blinding).
Group D will be a placebo group for this intervention, in case which single blinding will be also applied. Intervention in group D will include the sham pulsed magnetic field. Stimulation will last 20 minutes (frequency: 0 Hz, Magnetic induction: 0 mT). The intervention will also be carried out in a comfortable, safe seating position on a specialized chair, with the field generator placed in the seat in the form of flat cushions.
Control group
Placebo

Outcomes
Primary outcome [1] 300291 0
Resting and functional bioelectrical activity of pelvic floor muscle assessed by electromyography
Timepoint [1] 300291 0
Before, after the intervention and after 1 and 24 hours
Primary outcome [2] 300292 0
The visualization and evaluation of the elastic properties of the tissue assessed by Vaginal Tactile Imager
Timepoint [2] 300292 0
Before, after the intervention and after 1 and 24 hours
Secondary outcome [1] 329637 0
None
Timepoint [1] 329637 0
None

Eligibility
Key inclusion criteria
Inclusion criteria assumed in the study will include: acquiring subjects' informed consent to participate in the study, urologist and physiotherapist permission, the overall well-being on the examination day, lack of contraindications for the sEMG measurement, lack of contraindications for DEMF stimulation, diagnosed SUI or MUI.
Minimum age
40 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will involve: age over 75 years; lack of menopause; previous gynecological surgeries; surgeries within the abdomen, pelvis, lower limbs - in the last 10 years; on the day of examination the occurrence of injuries of the lower limb, pelvis or spine; organ prolapse; a history of cesarean section; third degree of urinary incontinence or faecal incontinence. In addition, the exclusion criteria will include: any neurological symptoms, systemic disease, diabetes, lumbar or pelvic pain in the last 6 months. For further measurements individuals who did not give written informed consent for the study, and when such consent will not be obtained from a urologist, will not be qualified for the study. Contraindications for DEMF stimulation will provide additional exclusion criteria of the study (cancer, heart pacemaker, hearing aid or other non-removable electronic devices, bleeding of any origin, pain of unknown origin, neurological diseases (epilepsy), very low blood pressure, metal pieces within the area of DEMF application, radiotherapy or chemotherapy, malaise during the examination, infection of the urogenital tract, allergy to nickel, the occurrence of pain during the study; resignation during the study).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2017
Actual
1/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
48
Final
Recruitment outside Australia
Country [1] 8413 0
Poland
State/province [1] 8413 0

Funding & Sponsors
Funding source category [1] 295049 0
Government body
Name [1] 295049 0
National Science Centre
Country [1] 295049 0
Poland
Primary sponsor type
Government body
Name
National Science Centre
Address
ul. Krolewska 57
30-081 Krakow, Poland
Country
Poland
Secondary sponsor category [1] 293861 0
University
Name [1] 293861 0
Wroclaw Medical University
Address [1] 293861 0
Wybrzeze L. Pasteura 1, 50-367 Wroclaw
Country [1] 293861 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296399 0
Bioethics Committee at Wroclaw Medical University
Ethics committee address [1] 296399 0
Wroclaw Medical University
Wybrzeze L. Pasteura 1, 50-367 Wroclaw
Poland
Ethics committee country [1] 296399 0
Poland
Date submitted for ethics approval [1] 296399 0
25/11/2016
Approval date [1] 296399 0
21/03/2017
Ethics approval number [1] 296399 0
KB-97/2017

Summary
Brief summary
The primary aim of the study is the objective electromyographic evaluation of pelvic floor muscle (PFM) and elastographic assessment of pelvic floor structures after application of deep electromagnetic field (DEMF) stimulation of pelvic floor in women with stress or mixed urinary incontinence symptoms (SUI, MUI). Researchers assumeed that DEMF stimulation will affect the bioelectrical activity of PFM and elastic properties of evaluated structures. Bioelectrical activity of PFM will be assessed by means of surface electromyography (sEMG). The evaluation of pelvic floor tissue elasticity will be conducted with the use of elasticity imaging device (EI). The main hypotheses assume that the intervention in the form of DEMF stimulation increases resting and functional bioelectrical activity of PFM and increases the elasticity of pelvic floor structures. The evaluation of selected biophysical parameters will also include a placebo group.
The study will be conducted at the Clinic and the Department of Urology and Urologic Oncology, University Hospital in Wroclaw, Poland. The target group of the study will involve postmenopausal women with symptoms of SUI and MUI. All recruited participants will be assessed according to the inclusion and exclusion criteria in order to qualify for the measurements. Participants will be randomly assigned to one of four comparison groups (A, B, C, D). Random assignment will be conducted by random.org. In group A - DEMF stimulation will be applied, in group magnetic stimulation will be used, and groups C and D will be the control groups (placebo) for the groups A and B respectively. In order to analyze the persistent changes of particular parameters the registration of selected phenomena will be conducted immediately before and after the stimulation as well as 1 hour and 24 hours later. Bioelectrical activity of PFM will be recorded using surface electromyograph with vaginal electrodes. The assessment of elasticity of the pelvic structures will be carried out with the use of an elastographic device equipped with specialized vaginal head. The interventions will require the use of equipment to carry out DEMF stimulation and magnetic stimulation.
The expected impact of the results on science development is the acquirement of knowledge on the influence of new DEMF stimulation on pelvic structures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70738 0
Dr Kuba Ptaszkowski
Address 70738 0
Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, address: Grunwaldzka 2, 50-355 Wroclaw, Poland,
Country 70738 0
Poland
Phone 70738 0
(+48) 606816161
Fax 70738 0
Email 70738 0
kuba.ptaszkowski@umed.wroc.pl
Contact person for public queries
Name 70739 0
Dr Kuba Ptaszkowski
Address 70739 0
Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, address: Grunwaldzka 2, 50-355 Wroclaw, Poland,
Country 70739 0
Poland
Phone 70739 0
(+48) 606816161
Fax 70739 0
Email 70739 0
kuba.ptaszkowski@umed.wroc.pl
Contact person for scientific queries
Name 70740 0
Dr Kuba Ptaszkowski
Address 70740 0
Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, address: Grunwaldzka 2, 50-355 Wroclaw, Poland,
Country 70740 0
Poland
Phone 70740 0
(+48) 606816161
Fax 70740 0
Email 70740 0
kuba.ptaszkowski@umed.wroc.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The authors tend to publish patients, but the decision has not yet been made. This is due to the lack of experience in publishing this type of data and the fear of improper use of this data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIAssessment of the Elastographic and Electromyographic of Pelvic Floor Muscles in Postmenopausal Women with Stress Urinary Incontinence Symptoms2021https://doi.org/10.3390/diagnostics11112051
N.B. These documents automatically identified may not have been verified by the study sponsor.