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NCT Number: NCT07494903

Effects of Vibrational Therapy on Pelvic Floor Muscle Strength and Tone in Healthy Women

This quasi-experimental study aims to evaluate the effects of mechanical vibration applied to the pelvic floor musculature in healthy women aged 18-45. The intervention involves vibrational therapy targeting the central fibrous nucleus of the perineum, with the goal of assessing changes in muscle tone, strength, and biomechanical properties. The study will also examine the tolerance to this technique, with data collected at baseline and after 8 weeks of treatment.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

his study investigates the effects of mechanical vibration applied to the pelvic floor musculature in healthy women aged 18 to 45 years. The intervention involves applying vibrational therapy to the central fibrous nucleus of the perineum, with the objective of assessing its impact on muscle tone, strength, and biomechanical properties such as rigidity, elasticity, and muscle stiffness. The study will also explore the tolerance of participants to this therapeutic technique.

The study follows a quasi-experimental design with a blinded evaluator. A total of 60 participants will be randomly assigned to one of four groups: three intervention groups receiving vibration at different frequencies (138 Hz, 41.5 Hz, and 24.9 Hz), and one control group receiving no intervention. The intervention will be administered twice a week for 8 weeks, with each session lasting 20 minutes.

Primary outcomes include changes in the tone and strength of the pelvic floor muscles, measured using various instruments such as the MyotonPro® for biomechanical parameters, the IEase XFT0010 for manometric measurements, and the Pelvimeter Phénix for dynamometry. Secondary outcomes include the evaluation of the vibration's impact on muscle elasticity, rigidity, and other biomechanical properties, as well as the participant's tolerance to the treatment.

The study is conducted in compliance with ethical principles set out in the Declaration of Helsinki, and participant data will be handled confidentially according to data protection regulations. The results of this research may contribute valuable insights into non-invasive treatments for pelvic floor dysfunctions, which are common in women and often impact their physical and mental well-being

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Throughout the intervention (ongoing during each session) and Post-intervention (after 8 weeks of treatment).

Exclusion criteria

  • 1. Urogenital Infections: Presence of any active urogenital infections. 2. Abdominal or Pelvic Surgery: History of abdominal or pelvic surgery. 3. Active Menstruation: Women who are menstruating at the time of the study. 4. Breastfeeding: Participants who are actively breastfeeding. 5. Mictrurition Symptoms: Presence of any urinary symptoms. 6. Pain: Pain upon palpation of the central fibrous nucleus of the perineum. 7. Sensory Alterations: Presence of altered sensitivity such as hypoalgesia, hyperalgesia, or allodynia.
  • Spinal Lesions: History of spinal cord injuries. 9. Neurological Conditions: Any neurological disorders. 10. Pelvic Organ Prolapse: Diagnosed prolapse of pelvic organs. 11. Obesity: Body Mass Index (BMI) ≥ 30 kg/m². 12. Active Oncology Treatment: Any current or recent cancer treatments. 13. Pregnancy: Women who are pregnant. 14. Pelvic Floor Pathologies: Diagnosed pelvic floor dysfunctions. 15. Ongoing Pelvic Floor Treatment: Participants currently receiving active pelvic floor treatments.
  • Dermatological Pathologies: Any active vulvar dermatological conditions.

Treatment and study plan

High frequency vibration group

Other

z. The treatment will be administered twice a week for 8 weeks, with each session lasting 20 minutes. The primary aim is to evaluate the effects of high-frequency vibration on the tone, strength, and biomechanical properties of the pelvic floor muscles.

Moderate frequency vibration group

Other

Participants in this group will receive mechanical vibration applied to the central fibrous nucleus of the perineum at a frequency of 41.5 Hz. The treatment will be administered twice a week for 8 weeks, with each session lasting 20 minutes. The focus is to assess the effects of moderate-frequency vibration on the muscle tone, strength, and biomechanical parameters of the pelvic floor musculature

Low frequency vibration group

Other

Participants in this group will receive mechanical vibration applied to the central fibrous nucleus of the perineum at a frequency of 24.9 Hz. The treatment will be administered twice a week for 8 weeks, with each session lasting 20 minutes. The goal is to evaluate how low-frequency vibration impacts the pelvic floor muscle tone, strength, and biomechanical properties compared to the other groups.

Primary outcomes

  1. Pelvic floor muscle tone

    Time frame: Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).

    The tone of the pelvic floor muscles will be measured using the MyotonPro® device, which assesses the frequency of oscillation (Hz) of the muscle. The tone will be evaluated at baseline and post-intervention to determine any changes resulting from the vibrational therapy.

Secondary outcomes

  1. Pelvic floor muscle strength

    Time frame: Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).

    Pelvic floor muscle strength will be assessed using two methods: Manometry (with the IEase XFT0010) to measure the pressure in mmHg during voluntary contraction, and Dynamometry (with the Pelvimeter Phénix) to measure force in Newtons (N) during vaginal contraction. These assessments will help evaluate changes in the muscle's ability to contract before and after the intervention.

  2. Biomechanical properties of pelvic floor musculature

    Time frame: Baseline (before intervention) and Post-intervention (after 8 weeks of treatment)

    Biomechanical properties such as muscle rigidity (N/m), elasticity (logarithmic decrement), and fluency (number of Deborah) will be measured using the MyotonPro®. This will help evaluate changes in the muscle's stiffness and viscoelastic properties resulting from the vibrational therapy.

  3. Pelvic floor dysfunction impact

    Time frame: Baseline (before intervention) and Post-intervention (after 8 weeks of treatment).

    The Pelvic Floor Distress Inventory (PFDI-20) questionnaire will be administered to measure the degree of pelvic floor dysfunction symptoms and their impact on the participant's daily life. This includes symptoms related to urinary incontinence, pelvic organ prolapse, and other pelvic health issues

  4. Tolerance to the vibration therapy

    Time frame: Throughout the intervention (ongoing during each session) and Post-intervention (after 8 weeks of treatment).

    Participants will be asked to rate their tolerance to the vibration therapy, including any discomfort or adverse effects experienced during the intervention. This will be recorded to assess the safety and acceptability of the treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Romero PhD, PhD

CONTACT

[email protected]

+34696879745

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Effects of Mechanical Vibration Applied to the Pelvic Floor Musculature: A Quasi-Experimental Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 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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