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

NCT07494903 | Not Yet Recruiting DMC

• 1 other identifier: 26/138-IC_P_CE
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healhty

Outcome Measures

Primary Outcomes (1)

• Pelvic floor muscle tone

  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.

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

Secondary Outcomes (4)

• Pelvic floor muscle strength

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

• Biomechanical properties of pelvic floor musculature

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

• Pelvic floor dysfunction impact

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

• Tolerance to the vibration therapy

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

Study Arms (3)

High frequency vibration group

EXPERIMENTAL

Participants in this group will receive mechanical vibration applied to the central fibrous nucleus of the perineum at a frequency of 138 Hz. 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.

Other: High frequency vibration group

Moderate frequency vibration group

ACTIVE COMPARATOR

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

Other: Low frequency vibration group

Low frequency vibration group

EXPERIMENTAL

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.

Other: Moderate frequency vibration group

Interventions

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.

High frequency vibration group

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

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.

Moderate frequency vibration group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Related Publications (3)

• Lee J, Lee K, Song C. Determining the Posture and Vibration Frequency that Maximize Pelvic Floor Muscle Activity During Whole-Body Vibration. Med Sci Monit. 2016 Oct 27;22:4030-4036. doi: 10.12659/msm.898011.

  PMID: 27787476 RESULT

• Rodrigues MP, Paiva LL, Ramos JGL, Ferla L. Vibratory perineal stimulation for the treatment of female stress urinary incontinence: a systematic review. Int Urogynecol J. 2018 Apr;29(4):555-562. doi: 10.1007/s00192-017-3444-y. Epub 2017 Aug 15.

  PMID: 28812109 RESULT

• Barassi G, Bellomo RG, Frondaroli F, Frondaroli S, Santarelli A, Di Felice PA, Supplizi M, Palermo T, Saggini R. Integrated Rehabilitation Approach with Manual and Mechanic-Acoustic Vibration Therapies for Urinary Incontinence. Adv Exp Med Biol. 2019;1211:41-50. doi: 10.1007/5584_2019_436.

  PMID: 31468357 RESULT

Central Study Contacts

Carlos Romero PhD, PhD

CONTACT

+34696879745; carlos.romero@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03