Training Models in Pelvic Floor Muscle Training

NCT07099170 | Recruiting DMC

• 1 other identifier: IzmirUEcon-PTR-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Muscle Exercise; Healthy Adult Women; Pelvic Floor Muscle Training

Keywords

pelvic floor muscle training; pelvic floor muscle exercise; Healthy Adult Women; Comparison Models

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)

• 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.

  Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)

Secondary Outcomes (2)

• Semi-Structured Form for Pelvic Floor Awareness

  Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)

• Participant Satisfaction

  Immediately after training (within 1 hours of completion of training)

Other Outcomes (4)

• Sociodemographic and Clinical Information

  Baseline (pre-training)

• Anthropometric

  Baseline (pre-training)

• Anthropometric - height

  Baseline (pre-training)

Study Arms (4)

Brochure-Based Pelvic Floor Muscle Training

EXPERIMENTAL

Behavioral: Brochure-Based Pelvic Floor Muscle Training

Verbal Instruction-Based Pelvic Floor Muscle Training

EXPERIMENTAL

Behavioral: Verbal Instruction-Based Pelvic Floor Muscle Training

Visual-Aided Pelvic Floor Muscle Training

EXPERIMENTAL

Behavioral: Visual-Aided Pelvic Floor Muscle Training

External Palpation-Aided Pelvic Floor Muscle Training

EXPERIMENTAL

Behavioral: External Palpation-Aided Pelvic Floor Muscle Training

Interventions

Visual-Aided Pelvic Floor Muscle Training BEHAVIORAL

Visual-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.

Visual-Aided Pelvic Floor Muscle Training

External Palpation-Aided Pelvic Floor Muscle Training BEHAVIORAL

External 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.

External Palpation-Aided Pelvic Floor Muscle Training

Verbal Instruction-Based Pelvic Floor Muscle Training BEHAVIORAL

Verbal 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.

Verbal Instruction-Based Pelvic Floor Muscle Training

Brochure-Based Pelvic Floor Muscle Training BEHAVIORAL

Brochure-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.

Brochure-Based Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Female
• Willingness to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: collaborator
• Izmir University of Economics: lead

Study Sites (1)

Izmir University of Economics

Izmir, İzmir, 35180, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Ipek Yavas, MSc, PT, Lecturer

CONTACT

+90-555-875-9645; ipekkyavas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc, Lecturer

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 1, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)