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Training Models in Pelvic Floor Muscle Training

Not Applicable
Recruiting
Conditions
Pelvic Floor Muscle Exercise
Healthy Adult Women
Pelvic Floor Muscle Training
Registration Number
NCT07099170
Lead Sponsor
Izmir University of Economics
Brief Summary

Pelvic floor muscle training (PFMT) is an exercise approach designed to improve the strength, endurance, power, relaxation, or coordination of the pelvic floor muscles. It is recommended as a first-line treatment for urinary incontinence (stress, urge, mixed), pelvic organ prolapse, and fecal incontinence. Evidence also suggests its potential to enhance sexual function in both men and women.

To teach proper pelvic floor contraction, individuals must first learn the anatomical location, structure, and function of these muscles. Various teaching strategies can support motor learning, such as verbal cues (commands or imagery), visual input (anatomical models or illustrations), physical guidance (tactile feedback), and environmental adjustments (comfortable positions, safe space). Yet, the choice of teaching method in clinical practice is currently based only on experience, not evidence.

This study aims to compare the effectiveness of four different PFMT teaching models-brochure-based, verbal instruction-based, visual instruction-based, and external palpation-aided-in teaching correct pelvic floor contraction and improving awareness in healthy adult women. It will be conducted as a four-arm randomized controlled trial. Participants will be evaluated before the training, immediately after, and one week later.

The findings from this study will help identify the most effective and practical approach for teaching PFMT. Although the study is conducted with healthy women without pelvic symptoms, the results will inform better training strategies for individuals with pelvic floor dysfunction, including those with urinary problems, chronic diseases, or pregnancy-related pelvic floor issues. Ultimately, this research seeks to fill a gap in the current literature and contribute to more evidence-based clinical practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
60
Inclusion Criteria
  • Age 18 years or older
  • Female
  • Willingness to participate in the study
Exclusion Criteria
  • Pregnancy
  • History of cesarean or vaginal delivery within the past 6 months
  • Previous pelvic floor muscle training
  • History of pelvic surgery
  • Currently receiving or having received treatment for pelvic organ prolapse

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Mean Bladder Base Displacement During Pelvic Floor Muscle ContractionBaseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)

Pelvic floor muscle activity will be objectively assessed using transabdominal B-mode ultrasound, which allows real-time visualization of muscle movement.

Participants will drink 500 ml of water and refrain from voiding before the test. While lying supine with knees flexed, a linear probe will be placed transabdominal suprapubically to visualize the bladder base. Bladder displacement during pelvic floor contraction will be measured by placing markers on the ultrasound image at rest and during contraction. The procedure will be repeated three times, and the average measurement in millimeters will be recorded.

Presence or Absence of Voluntary Pelvic Floor Muscle Contraction Assessed by PalpationBaseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)

The participants' ability to contract their pelvic floor muscles will be assessed by a specialized physiotherapist through external palpation and categorized as no voluntary contraction, weak, moderate, or strong contraction.

Secondary Outcome Measures
NameTimeMethod
Semi-Structured Form for Pelvic Floor AwarenessBaseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)

A semi-structured questionnaire was developed to assess participants' knowledge and awareness regarding pelvic floor anatomy, function, dysfunction, and exercises.

Participant SatisfactionImmediately after training (within 1 hours of completion of training)

Participant satisfaction with the training program will be assessed immediately after the intervention using a Visual Analog Scale (VAS). Participants will be asked to respond to two questions: (1) "How satisfied are you with the training you received?" and (2) "Do you think the training you received was useful?" Each question will be rated on a scale from 0 to 10, where 0 indicates "Not satisfied at all" or "Not useful at all" and 10 indicates "Extremely satisfied" or "Extremely useful." The responses will be recorded as continuous variables.

Trial Locations

Locations (1)

Izmir University of Economics

🇹🇷

Izmir, Turkey

Izmir University of Economics
🇹🇷Izmir, Turkey
Ipek Yavas
Contact
+90-555-875-9645
ipekkyavas@gmail.com

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