About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Throughout the intervention (ongoing during each session) and Post-intervention (after 8 weeks of treatment).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
High frequency vibration group
Other interventionz. 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 interventionParticipants 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 interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Pelvic floor muscle strength
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.
Biomechanical properties of pelvic floor musculature
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.
Pelvic floor dysfunction impact
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
Tolerance to the vibration therapy
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.
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Sponsors and contacts
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