Clinical trial NCT06450795: Effectiveness of High Intensity Electromagnetic Therapy and Pelvic Floor Exercises in Women With Urinary Incontinence
Official title: Effectiveness of High Intensity Electromagnetic Therapy and Pelvic Floor Exercises in Women With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: electromagnetic stimulation
urinary incontinence
pelvic floor muscle training
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: International Incontinence Consultation Questionnaire-Short Form
timeFrame: 5 minute
measure: Urogenital Distress Inventory (UDE-6)
timeFrame: 5 minute
measure: King's Health Questionnaire
timeFrame: 5 minute
measure: EMG-Biofeedback
timeFrame: 5 minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: