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

NCT ID: NCT06450795

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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.

Intervention Type: BEHAVIORAL

HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.

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.

Group Type: EXPERIMENTAL

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.

Intervention Type: BEHAVIORAL

HIFEM treatment for 6 weeks, 2 days a week for 28 minutes. The evaluations will be repeated at the end of the treatment.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

high intensity functional electromagnetic stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

mehtap kilicoz

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mehtap KILICOZ BAAKR

Role: CONTACT

mehtap.kilicoz@hotmail.com

+905348823658

Other Identifiers

E-10840098-202.3.02-2981

Identifier Type: -

Identifier Source: org_study_id