None listed
Conditions
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.
Interventions
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 insi
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.
Sponsors
National Science Centre
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
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.
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).
Outcome results
None listed