Assessment of deep electromagnetic field stimulation of pelvic floor muscles in womenwith symptoms of stress and mixed urinary incontinence

Recruiting

• Conditions: urinary incontinence; Physical Medicine / Rehabilitation - Physiotherapy; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12617000118303
• Lead Sponsor: ational Science Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-23
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 200

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resting and functional bioelectrical activity of pelvic floor muscle assessed by electromyography[Before, after the intervention and after 1 and 24 hours];The visualization and evaluation of the elastic properties of the tissue assessed by Vaginal Tactile Imager[Before, after the intervention and after 1 and 24 hours]

Secondary Outcome Measures

Name	Time	Method
one[None]