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Completed

NCT Number: NCT07554612

The Impact of Trunk and Lower Extremity Electrical Stimulation on Pelvic Floor Muscle Strength in Females

This study aims to investigate the effects of whole-body electrical muscle stimulation (EMS) applied to the trunk and lower extremity muscles on pelvic floor muscle strength in healthy women. Since pelvic floor muscles are deep-seated and can be difficult to activate voluntarily, this research explores whether stimulating related muscle groups (core and legs) can provide an indirect benefit to pelvic floor strength. Participants will be divided into three groups (EMS + exercise, Sham-EMS + exercise, and exercise only) and will undergo a 6-week intervention program. Changes in pelvic floor muscle strength will be evaluated using a perineometer to determine the effectiveness of this non-invasive approach.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Okan University Hospital

Istanbul, 34959, Turkey (Türkiye)

About this study

The primary aim of this clinical study is to evaluate the indirect effect of Electrical Muscle Stimulation (EMS) applied to the lower extremity and trunk muscles on pelvic floor muscle (PFM) strength in healthy women. While PFM training is the gold standard in women's health, many individuals experience difficulty in isolating and effectively contracting these muscles. This study aims to create an effective EMS application by leveraging the physiological synergy between the core/lower extremity muscles and the pelvic floor.

All participants will attend a comprehensive 6-week intervention program with sessions scheduled twice weekly. During these sessions, specific exercises targeting major muscle groups will be performed. For relevant groups, electrical stimulation synchronized with these movements will be applied to increase muscle fiber activation.

PFM strength will be assessed using a digital perineometer at two time points: baseline (pre-intervention) and at the end of the 6-week program (post-intervention). To ensure consistency, all measurements will be taken by the same investigator. The aim of this study is to determine whether systemic activation of trunk and lower extremity muscles via EMS leads to a measurable increase in pelvic floor muscle tone and strength, thus offering a novel, non-invasive supportive method in physiotherapy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biological female volunteers aged between 18 and 45 years.
  • Having a Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
  • Being sedentary or having a low level of physical activity (not participating in regular exercise programs in the last 6 months).
  • Volunteering to participate in the study and signing the informed consent form.
  • Being mentally and physically capable of following the 12-week exercise and EMS protocol.

Exclusion criteria

  • Having a history of pelvic floor surgery or major abdominal surgery.
  • Being pregnant or having given birth within the last 6 months.
  • Having a diagnosed neurological disorder that affects muscle control (e.g., Multiple Sclerosis, Parkinson's).
  • Having an active urinary tract infection or symptomatic pelvic organ prolapse.
  • Having a cardiac pacemaker or any metal implants in the trunk and hip area (contraindications for EMS).
  • Having chronic diseases that may interfere with exercise participation (e.g., uncontrolled hypertension, severe cardiovascular disease).
  • Having skin lesions, infections, or severe sensitivity in the areas where EMS electrodes will be applied.
  • Using medications that affect muscle metabolism or the neuromuscular system.

Treatment and study plan

Electrical muscle stimulation

Device

Electrical stimulation applied via electrodes integrated into a specialized garment, targeting core and lower extremity muscles.

Standardized Exercise Protocol

Other

A six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly

Sham (No Treatment)

Device

The application of electrical stimulation that is only felt sensorially, not at a level that can induce muscle contraction.

Other names: Sham EMS

Primary outcomes

  1. Pelvic Floor Muscle Strength

    Time frame: Baseline (Week 0), Mid-intervention (Week 7), and Follow-up (Week 12)

    Evaluation of the maximal voluntary contraction of the pelvic floor muscles. A mechanical perineometer with a pressure gauge will be used to measure the pressure changes.

Sponsors and collaborators

Lead sponsor

Okan University

Other

Registry information

Official study title

Investigation of the Effects of Electrical Stimulation Applied to Trunk and Lower Extremity Muscles on Pelvic Floor Muscle Strength in Women

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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