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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

urinary incontinence

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Renal and Urogenital

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]

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]

Resting and functional bioelectrical activity of pelvic floor muscle assessed by electromyography

Timepoint [1]

Before, after the intervention and after 1 and 24 hours

Primary outcome [2]

The visualization and evaluation of the elastic properties of the tissue assessed by Vaginal Tactile Imager

Timepoint [2]

Before, after the intervention and after 1 and 24 hours

Secondary outcome [1]

None

Timepoint [1]

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?

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

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Science Centre

Address [1]

ul. Krolewska 57
30-081 Krakow, Poland

Country [1]

Poland

Primary sponsor type

Government body

Name

National Science Centre

Address

ul. Krolewska 57
30-081 Krakow, Poland

Country

Poland

Secondary sponsor category [1]

University

Name [1]

Wroclaw Medical University

Address [1]

Wybrzeze L. Pasteura 1, 50-367 Wroclaw

Country [1]

Poland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bioethics Committee at Wroclaw Medical University

Ethics committee address [1]

Wroclaw Medical University
Wybrzeze L. Pasteura 1, 50-367 Wroclaw
Poland

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

25/11/2016

Approval date [1]

21/03/2017

Ethics approval number [1]

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

Dr Kuba Ptaszkowski

Address

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

Poland

Phone

(+48) 606816161

Fax

[email protected]

Contact person for public queries

Name

Kuba Ptaszkowski

Address

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

Poland

Phone

(+48) 606816161

Fax

[email protected]

Contact person for scientific queries

Name

Kuba Ptaszkowski

Address

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

Poland

Phone

(+48) 606816161

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Dimensions AI	Assessment of the Elastographic and Electromyographic of Pelvic Floor Muscles in Postmenopausal Women with Stress Urinary Incontinence Symptoms	2021	https://doi.org/10.3390/diagnostics11112051

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically