Pelvic Floor Muscle ExerciseNCT07099170
Training Models in Pelvic Floor Muscle Training
A study testing Brochure-Based Pelvic Floor Muscle Training, Verbal Instruction-Based Pelvic Floor Muscle Training and Visual-Aided Pelvic Floor Muscle Training in people with Pelvic Floor Muscle Exercise and Healthy Adult Women, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Exercise, Healthy Adult Women, Pelvic Floor Muscle Training
- What is being tested?
- Brochure-Based Pelvic Floor Muscle Training, Verbal Instruction-Based Pelvic Floor Muscle Training and Visual-Aided Pelvic Floor Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Female
- Willingness to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir University of Economics
Izmir, İzmir, 35180
Ipek Yavas, +90-555-875-9645, ipekkyavas@gmail.com
About this study
Official title: Comparison of Training Models in Pelvic Floor Muscle Training in Healthy Adult Women
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.
Read more
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.
- Being tested
- Brochure-Based Pelvic Floor Muscle Training, Verbal Instruction-Based Pelvic Floor Muscle Training, Visual-Aided Pelvic Floor Muscle Training, External Palpation-Aided Pelvic Floor Muscle Training
- Keywords
- pelvic floor muscle training, pelvic floor muscle exercise, Healthy Adult Women, Comparison Models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brochure-Based Pelvic Floor Muscle TrainingBehavioural
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.
Verbal Instruction-Based Pelvic Floor Muscle TrainingBehavioural
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.
Visual-Aided Pelvic Floor Muscle TrainingBehavioural
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.
External Palpation-Aided Pelvic Floor Muscle TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brochure-Based Pelvic Floor Muscle Training | Experimental | Not described Receives: Behavioral: Brochure-Based Pelvic Floor Muscle Training |
| Verbal Instruction-Based Pelvic Floor Muscle Training | Experimental | Not described Receives: Behavioral: Verbal Instruction-Based Pelvic Floor Muscle Training |
| Visual-Aided Pelvic Floor Muscle Training | Experimental | Not described Receives: Behavioral: Visual-Aided Pelvic Floor Muscle Training |
| External Palpation-Aided Pelvic Floor Muscle Training | Experimental | Not described Receives: Behavioral: External Palpation-Aided Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
A semi-structured questionnaire was developed to assess participants' knowledge and awareness regarding pelvic floor anatomy, function, dysfunction, and exercises.
Measured: Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)
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.
Measured: Immediately after training (within 1 hours of completion of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start4 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Muscle ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Collaborators
- Dokuz Eylul University
- Responsible party
- Principal investigator, Ipek Yavas, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099170
- Sponsor's protocol ID
- IzmirUEcon-PTR-01
- Status last verified
- Mar 2026
- First submitted
- 18 Jul 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Training Models in Pelvic Floor Muscle Training in Healthy Adult Women
- ClinicalTrials.gov ID
- NCT07099170
- Acronym / sponsor ID
- IzmirUEcon-PTR-01
- Keywords
- pelvic floor muscle training, pelvic floor muscle exercise, Healthy Adult Women, Comparison Models
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Collaborators
- Dokuz Eylul University
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Female
- Willingness to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brochure-Based Pelvic Floor Muscle TrainingBrochure-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. | Behavioural | Brochure-Based Pelvic Floor Muscle Training |
| Verbal Instruction-Based Pelvic Floor Muscle TrainingVerbal 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. | Behavioural | Verbal Instruction-Based Pelvic Floor Muscle Training |
| Visual-Aided Pelvic Floor Muscle TrainingVisual-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. | Behavioural | Visual-Aided Pelvic Floor Muscle Training |
| External Palpation-Aided Pelvic Floor Muscle TrainingExternal 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. | Behavioural | External Palpation-Aided Pelvic Floor Muscle Training |
Primary outcome
Mean Bladder Base Displacement During Pelvic Floor Muscle Contraction
Time frame: Baseline (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 Palpation
Time frame: Baseline (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.
2 secondary outcomes
Semi-Structured Form for Pelvic Floor Awareness
Time frame: Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)
Participant Satisfaction
Time frame: Immediately after training (within 1 hours of completion of training)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brochure-Based Pelvic Floor Muscle Training, Verbal Instruction-Based Pelvic Floor Muscle Training and Visual-Aided Pelvic Floor Muscle Training in people with Pelvic Floor Muscle Exercise and Healthy Adult Women, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ipek Yavas, MSc, PT, Lecturer (+90-555-875-9645, ipekkyavas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Bladder Base Displacement During Pelvic Floor Muscle Contraction (time frame: Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.