Training Models in Pelvic Floor Muscle Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIzmir University of Economics
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older
Female
Willingness to participate in the study
Disqualifiers
Pregnancy
History of cesarean or vaginal delivery within the past 6 months
Previous pelvic floor muscle training
History of pelvic surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Brochure-Based Pelvic Floor Muscle Training
BehavioralBrochure-based pelvic floor muscle training will be conducted by providing participants with a brochure containing information about the anatomy, functions, and importance of the pelvic floor, as well as instructions on how to contract the pelvic floor muscles. All educational content will be delivered solely through the brochure, and no additional verbal or written information will be provided to the participants. The brochure will include detailed explanations of pelvic floor muscle contractions and imagery techniques. Participants will be given 30 minutes to review the brochure and apply the training independently.
Verbal Instruction-Based Pelvic Floor Muscle Training
BehavioralVerbal instruction-based pelvic floor muscle training involves providing participants with information about the anatomy, functions, and importance of the pelvic floor, as well as instruction on how to correctly contract the pelvic floor muscles. All explanations will be delivered verbally, and no additional equipment or visual aids will be used. During the training, imagery techniques based on verbal cues will be employed. Commonly used metaphors such as a hammock, a faucet, an elevator, or a ship will be utilized to facilitate imagery. Participants will be asked to focus on their pelvic floor and imagine the contractions, and they will be informed about the potential effects of these contractions during the session.
Visual-Aided Pelvic Floor Muscle Training
BehavioralVisual-aided pelvic floor muscle training includes providing participants with information about the anatomy, functions, and importance of the pelvic floor, as well as training on how to properly contract the pelvic floor muscles. The training will be conducted using anatomical models, visual materials, and videos. Following the explanation of pelvic floor anatomy with models and visual aids, the function and importance of the pelvic floor will be presented through video demonstrations. During the session, the pelvic floor will be visually represented using common metaphors such as a hammock, a faucet, an elevator, or a ship, and these visuals will support the use of imagery techniques. Participants will be asked to focus on their pelvic floor and imagine the contractions, and they will be provided with information about the expected effects of the contractions.
External Palpation-Aided Pelvic Floor Muscle Training
BehavioralExternal Palpation-Aided Pelvic Floor Muscle Training This training involves educating participants on the pelvic floor's anatomy, function, and importance, along with instructions on proper muscle contraction. After an educational session using anatomical models, visuals, and videos, external palpation is used to guide correct muscle activation. In a hook-lying position and fully clothed, participants receive light, transverse pressure from a physiotherapist on key pelvic floor muscles (ischiocavernosus, bulbospongiosus/bulbocavernosus, or perineum). The therapist observes real-time muscle response, provides feedback, and offers verbal cues. Imagery techniques (e.g., hammock, faucet, elevator, ship) may be used to support motor learning and awareness.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Brochure-Based Pelvic Floor Muscle TrainingExperimental treatment 1 intervention
Group B: Verbal Instruction-Based Pelvic Floor Muscle TrainingExperimental treatment 1 intervention
Group C: Visual-Aided Pelvic Floor Muscle TrainingExperimental treatment 1 intervention
Group D: External Palpation-Aided Pelvic Floor Muscle TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Bladder Base Displacement During Pelvic Floor Muscle Contraction
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.
Time frame
Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)2
Presence or Absence of Voluntary Pelvic Floor Muscle Contraction Assessed by Palpation
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.
Time frame
Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)Secondary outcomes
1
Semi-Structured Form for Pelvic Floor Awareness
A semi-structured questionnaire was developed to assess participants' knowledge and awareness regarding pelvic floor anatomy, function, dysfunction, and exercises.
Time frame
Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)2
Participant Satisfaction
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.
Time frame
Immediately after training (within 1 hours of completion of training)Other outcomes
1
Sociodemographic and Clinical Information
Data on age, sex, smoking status, employment status, marital status, regular exercise habits, and medical history will be collected using the form provided in the appendix.
Time frame
Baseline (pre-training)2
Anthropometric
body weight.
Time frame
Baseline (pre-training)3
Anthropometric - height
height
Time frame
Baseline (pre-training)4
Kinesthetic and Visual Imagery Questionnaire
Questionnaire evaluates participants' ability to visualize (visual imagery) and feel (kinesthetic imagery) the movements. It consists of 10 movements. For each item, participants first perform the movement, then imagine watching themselves perform it and rate the clarity of the image on a 5-point scale (1 = no image, 5 = as clear as real). Next, they repeat the movement and then imagine performing it, focusing on the sensation, and rate the intensity (1 = no sensation, 5 = as intense as real). This process is repeated for all 10 movements.
Time frame
Baseline (pre-training)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Izmir University of Economics
Lead sponsor
Dokuz Eylul University
Collaborator
Source ClinicalTrials.gov