Assessment of deep electromagnetic field stimulation of pelvic floor muscles in womenwith symptoms of stress and mixed urinary incontinence: a randomized, single blindedstudy with a placebo group.

ational Science Centre0 个研究点目标入组 200 人开始时间: 2017年1月23日最近更新: 2019年1月28日

适应症

试验速览

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•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.

•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).

发起方

ational Science Centre