An interventional study of 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. in Urinary Incontinence, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 44 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Also known as: high intensity functional electromagnetic stimulation
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.
Time frame: 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.
Time frame: 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'.
Time frame: 5 minute
EMG-Biofeedback
Used to evaluate pelvic floor muscle activation
Time frame: 5 minute
Plan to share: No
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Istanbul Medipol University Hospital