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Pelvic Floor Muscle WeaknessNCT06306703

Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women

A study testing group1, group2, group 3 in people with Pelvic Floor Muscle Weakness, run by Duygu Sultan Oge at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Read more about this study

Who is it for?
Ages 20 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pelvic Floor Muscle Weakness
What is being tested?
group1, group2, group 3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Volunteering to participate in the study Getting a score of 25 or more from the "Mini Mental Test" Having pelvic floor muscle contraction ability Not having received pelvic floor muscle training before Vaginal examination Volunteering for education

Who cannot join

  • Pregnancy Presence of symptomatic pelvic organ prolapse over stage 2 Cooperation problem Presence of urinary infection Epilepsy Accompanying neurological disease

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe Universty

    Ankara

Other trials in Turkey (Türkiye)

About this study

The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods.

Read the detailed description

The pelvic region, from inside to outside, consists of the endopelvic fascia that connects the pelvic organs to the side walls of the pelvis, the levator ani muscle (pubococcygeus, iliococcygeus and puborectalis), perineal membrane (urogenital diaphragm), external genital muscles (ischiocavernosus, bulbospongiosus and transversus perinei superficialis), external genital organs and It consists of skin. The perineal area is clinically the area between the vagina and the anus[1].

When the Levator Ani muscle was examined histochemically under an electron microscope, it was shown that it consisted of Type 1 (slow twitch-67%) and Type 2 (fast twitch-33%) striated muscle fibers. Type 1 fibers are resistant to fatigue and can produce contractions for long periods of time. Type 2 fibers have high contraction strength but have low resistance to fatigue. While Type 2 fibers cause sudden contraction in situations that increase intra-abdominal pressure, such as coughing, sneezing, heavy lifting, Type 1 fibers maintain the tone required for continence without fatigue for a long time [1, 2].

The pelvic floor has important functions in ensuring the continence mechanism, providing structural support to the pelvic openings such as the urethra, vagina and anus, supporting the pelvic organs, and performing vital activities such as sexual function and birth [3, 4].

Damage or weakening of the pelvic floor due to reasons such as pregnancy, birth, newborn weight, menopause, age, obesity, smoking, hysterectomy, constipation, systemic diseases, genetics, bad urination habits, constipation, heavy sports, or tension in the structures that form it. In this case, it may cause problems such as urinary incontinence, anorectal dysfunction, pelvic organ prolapse, pelvic pain or sexual dysfunction, and these pathologies are generally defined as pelvic floor dysfunction[4]. Although pelvic floor problems are not life-threatening, they affect people's psychological, social and physical well-being and negatively affect their quality of life by causing limitations in their work, family, social and sexual lives [5].

The pelvic floor can be evaluated by many different methods. The aim is to objectively evaluate the anatomy of the pelvic floor and pelvic organs and relate symptoms to anatomical findings. The methods used in the evaluation of the pelvic floor muscles are generally observation, palpation, electromyography (EMG), EMG with biofeedback, perineometer, pelvic floor dynamometer, ultrasonographic imaging (USG) and magnetic resonance imaging (MRI)[6]. Evaluations can be performed in the lithotomy position or standing.

There are two components to proper pelvic floor muscle contraction: compression of the pelvic openings and pulling inward in the cranial direction. Some explanations for why there is difficulty in voluntary pelvic floor muscle contraction: The fact that the pelvic floor muscles are in a place that cannot be seen in the pelvis, many people do not have knowledge about pelvic floor muscle contraction and are not aware of the automatic contractions of these muscles, from a neurophysiological point of view, voluntary contraction is difficult because the muscles are small, the pelvic and perineal areas are more prone to straining and defecation. and since they are related to excretion, the primary awareness is in this direction [7].

Some incorrect behaviors may occur while performing pelvic floor muscle contraction. These are reported as contraction of the abdominal muscles, hip adductor muscles or gluteal muscles instead of the pelvic floor muscles, holding the breath, excessive breathing and straining [7].

Studies in the literature report that more than 30% of women specifically have problems with pelvic floor muscle contraction [8]. There are studies reporting that approximately 25% of women perform the Valsalva maneuver instead when pelvic floor muscle contraction is requested [3]. In a study conducted in Austria, it was reported that during routine gynecological evaluation, 44.9% of women could not make correct pelvic floor muscle contraction and only 26.5% could perform muscle contraction without increasing intra-abdominal pressure [9]. There are studies reporting that when women contract their pelvic floor muscles, they also include other muscles in the contraction, and some of them strain their pelvic floor muscles rather than pulling them inwards [7]. In our study, investigators planned to evaluate the pelvic floor muscle contractions of women who had not received pelvic floor muscle training before and after different teaching methods and the compensations they used during this process.

Kegel reported that the majority of women did not have awareness of muscle function, so he performed the exercises with a perineometer, which makes muscle contraction visible with the help of an indicator. PTFE can be applied alone or using various devices such as biofeedback [8]. In our study, it was planned to teach one group only by verbal explanation, another group by digital vaginal palpation, and the third group by teaching pelvic floor muscle contraction with a perineometer.

In their study, Dietz et al. evaluated levator activity with transabdominal USG and aimed to teach patients levator muscle contraction directly on the screen by creating visual biofeedback with ultrasonography, with a maximum of 5 minutes of training. As a result, they emphasized that transabdominal USG provides good biofeedback to women who are not suitable for compensations and vaginal training. Thus, they advised women who came to the clinic for examination that pelvic floor muscle contraction could be taught in a very short time with USG [10]. In this study, based on this study, investigators will evaluate hiatal aperture and pelvic floor elevation with USG before and after different teaching methods.

Rodas et al. emphasize that pelvic floor muscle training should be specific to each patient and that the pelvic floor therapist should know which equipment or therapeutic aids are more effective to use for evaluation [2]. As a result of this study, investigators will discuss the advantages and disadvantages of pelvic floor muscle contraction teaching methods and provide clinicians with evidence-based information in this field.

In the literature, physiotherapy and rehabilitation approaches used to teach pelvic floor muscle contraction are verbal instructions, biofeedback, perineometer, vaginal cone, Foley catheter, tampon, three-dimensional real time ultrasound and virtual reality training. Verbal instructions used during training are necessary to elicit rapid and strong contraction of the pelvic floor muscles. One of the most frequently used verbal instructions in training is "Pinch and Pull" instruction. Another method for patients to understand correct pelvic floor muscle contraction is to use visual imagery techniques when describing the contraction. Visualizations such as closing the tap or door for squeezing, or the elevator going up for pulling in or holding can be used [7]. To describe correct muscle contraction, the movement can be likened to eating spaghetti, drinking water through a straw, the movement of a jellyfish, or the vacuum movement created in a vacuum cleaner. The investigator will use these metaphors in the training.

To the investigators knowledge, no study has been found in the literature comparing the techniques in which participants are taught pelvic floor muscle contraction with different methods before and after the training. The investigators think that will make new contributions to the literature in this field with their study.

Being tested
group1, group2, group 3
Keywords
pelvic floor muscle contraction, pelvic floor assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • group1, group2, group 3Other

    to teaching with verbal instruction to teaching with digital vaginal palpation to teaching with perineometer

Study groups in NCT06306703
Study groupRoleWhat they receive
group1, verbal instructionExperimentalNot described
Receives: Other: group1, group2, group 3
group 2, digital vaginal palpationExperimentalNot described
Receives: Other: group1, group2, group 3
group 3, perineometerExperimentalNot described
Receives: Other: group1, group2, group 3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG)

    During evaluation with 2D USG, hiatal aperture measurements will be made at rest and at maximum voluntary contraction. Measurements will be repeated before and after individuals receive training, and any numerical changes that may occur will be recorded[11,12].

    Measured: at the beginning 5 minutes, at the end 5 minutes

  2. Pelvic Floor Muscle Strength and Endurance:

    Pelvic floor muscle strength and endurance will be evaluated with a non-invasive vaginal perineometer with digital vaginal palpation

    Measured: 5 minutes

  3. pelvic floor power, minimum and maximum muscle contraction values

    Pelvic floor power will be evaluated with intravajinal biofeedback electromyograhy(EMG)

    Measured: 5 minutes

Secondary outcomes (9)
  1. DETAILED STORIES OF THE PATIENTS

    The physical characteristics of the patients such as age (years), height, weight, BMI, demographic data such as educational status, employment status, and marital status will be recorded. The detailed history will include a CV inquiring about chronic diseases and surgeries, a family history inquiring about diseases in first-degree relatives, and a gynecological history inquiring about previous gynecological diseases and surgeries, if any. The patients' obstetric history, which questions gravida (number of pregnancies), parity (number of births), abortus (number of miscarriages), number of dilations and curettages, type of birth, birth weight and interventions used at birth, will also be recorded. In addition; Menstrual status (regular menstruation, irregular menopause, spontaneous menopause, surgical menopause) will be questioned.

    Measured: 5 minutes

  2. Pelvic Floor Health Knowledge Test:

    This test, developed and validated by Al-Deges et al., consists of 29 questions. The 'test yes-no-don't know?' which contains questions about pelvic floor health. It is answered with options. This test will be applied to women before they receive pelvic floor training. In this way, the knowledge level of the women included in the study about the pelvic floor will be evaluated[13].

    Measured: 5 minutes

  3. Global Pelvic Floor Disorder Questionnaire(GPFDQ)

    GPFDQ, which is used in the evaluation and determination of the severity of stress urinary incontinence, frequent urination, sudden urination, urge incontinence, urination difficulty, pelvic organ prolapse, obstructive defecation, anal incontinence and dyspareunia symptoms, which are frequently encountered in pelvic floor dysfunctions, has been adapted to Turkish, its validity and It is a reliable survey. In our study, we will use this survey to eliminate women's discomfort regarding these problems [14].

    Measured: 5 minutes

  4. Visual Analog Scale (VAS) assessment for pelvic pain

    VAS scores will be recorded to question the pelvic pain of the women included in the study. In the 10-centimeter long VAS, 0 indicates no pain, while 10 indicates the most severe pain. Individuals are asked to mark the part on the scale that expresses their pain [15].

    Measured: 1 minute

  5. Determining the severity of incontinence

    The International Incontinence Severity Index is used to reveal the severity, frequency and type of urinary incontinence and to show how much urinary incontinence affects the person's quality of life[16].

    Measured: 1 minute

  6. Sensory Evaluation

    Sensory test will be performed as a result of sharp-blunt, hot-cold tests applied to the sensory area innervated by the sacral 2-4 segmental nerves, in order to determine whether the patient has any sensory loss in these dermatomes [17].

    Measured: 1 minute

  7. Pelvic Floor Reflex Evaluation:

    As part of the neurological examination, evaluation of the pudendal nerve and Sacral 2-4 sacral reflexes should be performed. In evaluating the bulbocavernous reflex, a cotton swab will be passed over the labia minora to check whether both labia contract equally. Secondly, in the anal reflex, the contraction caused by rubbing the cotton swab against the perianal skin will be evaluated[18].

    Measured: 1 minute

  8. Evaluation of Mistakes Made During Pelvic Floor Muscle Contraction

    Contraction of abdominal muscles instead of pelvic floor muscles: While the evaluations are being made, biofeedback EMG (NeuroTrac® Myo Plus Pro) superficial electrodes will be placed at the spina iliaca anterior superiors level for possible contraction in the abdominal muscles and the muscle activation response will be recorded in mV..

    Contraction of adductor muscles instead of pelvic floor muscles, Contraction of the gluteal muscles instead of the pelvic floor muscles, Excessive breathing, Holding the breath and pushing(7).

    Measured: 5 minutes

  9. Pelvic organ prolapse evaluation

    to classified pelvic organ prolapse

    Measured: 1 minute

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion15 Jun 2024
  4. Study completion30 Dec 2024

Resources

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
Model description
prospective randomized
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06306703
Sponsor's protocol ID
PhD Thesis of Duygu Sultan Oge
Other IDs
224S541
Status last verified
Sep 2026
First submitted
4 Mar 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing group1, group2, group 3 in people with Pelvic Floor Muscle Weakness, run by Duygu Sultan Oge 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Sep 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG) (time frame: at the beginning 5 minutes, at the end 5 minutes). The study lists 3 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 18 Sep 2026.

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