Effectiveness of High Intensity Electromagnetic Therapy and Pelvic Floor Exercises in Women With Urinary Incontinence

The aim of this study is to evaluate the effect of pelvic floor exercises and high intensity electromagnetic therapy on pelvic floor muscle function, quality of life and urinary parameters in women with stress urinary incontinence. The individuals to be included in the study will be selected from women with stress urinary incontinence who receive follow-up from Medipol Acıbadem Hospital. Women who meet the inclusion criteria will be explained the details of the study by the responsible researcher and an informed consent form will be presented. The study is planned as two groups:

Group 1: Pelvic floor muscle training (PBST) group. Group 2: Pelvic floor muscle training and high intensity functional electromagnetic stimulation (HIFEM) treatment group.

Envelope opening method will be used for randomisation of the participants into two groups. They will be included in the first or second group according to the number in the envelope they choose.

Each participant will be given a baseline assessment. Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Participants in 2 groups will also receive HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.

Research Outcome Measures:

Demographic and Clinical Characteristics International Incontinence Consultation Questionnaire-Short Form Urogenital Distress Inventory (UDI-6) Quality of Life King Health Survey Muscle function Emg-Biofeedback

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Behavioral: Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehtap KILICOZ BAAKR; Phone Number: +905348823658; Email: mehtap.kilicoz@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed as stress urinary incontinence by a physician,
• Between the ages of 20-65,
• Has not had recurrent vaginitis infection,
• Women with no active urinary tract infection or more than 3 urinary tract infections in the last 1 year will be included in the study.

Exclusion Criteria:

• History of cardiac implant or untreated cardiac arrhythmia,
• The presence of a metal implant,
• Vaginal and pelvic surgery within the last 6 months,
• Gave birth within the last 12 weeks and had a history of miscarriage within 6 weeks,
• A recent surgical procedure,
• Any concurrent UI treatment,
• With renal and hepatic insufficiency,
• Neurological or neuromuscular disease
• It will be excluded in case of any contraindication listed in the investigational device manual.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity functional electromagnetic stimulation (HIFEM) treatment group; Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists. Additionally, Participants will also receive HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.	Behavioral: Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.; HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.; Other Names: high intensity functional electromagnetic stimulation
Experimental: Pelvic floor muscle training group; Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.	Behavioral: Participants in both groups will then receive PTKE treatment for 8 weeks, 3 days a week for 30-45 minutes, under the supervision of specialist physiotherapists.; HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.; Other Names: high intensity functional electromagnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMG-Biofeedback	Used to evaluate pelvic floor muscle activation	5 minute
International Incontinence Consultation Questionnaire-Short Form	Urinary incontinence symptom severity and its effect on quality of life will be evaluated with the ICIQ-SF, the reliability and validity of the Turkish version of which was performed by Çetinel et al. The scale consists of a total of 6 items questioning the type, frequency and amount of urinary incontinence and the effects of incontinence on the individual's life. The scores that can be obtained from the scale vary between 0-21 and a higher score indicates an increase in the severity of incontinence.	5 minute
Urogenital Distress Inventory (UDE-6)	The UDI-6 consists of 6 questions and is graded with a 4-point Likert-type score. A minimum score of 0 is obtained from the UDE-6 and this means that 'the patient is not disturbed at all', while the maximum score of 18 means that 'the patient is extremely disturbed by the symptoms'. The scores are converted to a percentage and the score is determined. The higher the score, the greater the severity of the symptoms.	5 minute
King's Health Questionnaire	The reliability and validity of the Turkish version of the quality of life related to urinary symptoms will be evaluated with the KSA, which was studied by Kaya et al. The KSA consists of two parts and includes 32 items. The best score that can be obtained from the complaint severity scale is '0' and the worst score is '30', while the best score that can be obtained from the answers given to all KSA sub-section problems is '0' and the worst score is '100'.	5 minute

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 8, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: urinary incontinence; pelvic floor muscle training; electromagnetic stimulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: E-10840098-202.3.02-2981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No