Clinical trial NCT06306703: Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women
Official title: Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Keywords: pelvic floor muscle contraction
pelvic floor assessment
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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 and volunteering for education.

Exclusion Criteria:

* Pregnancy, presence of symptomatic pelvic organ prolapse over stage 2, cooperation problem, presence of urinary infection, epilepsy, and accompanying neurological disease.

Primary outcomes:
measure: ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG)
timeFrame: at the beginning 5 minutes, at the end 5 minutes
measure: Pelvic Floor Muscle Strength and Endurance:
timeFrame: 5 minutes
measure: pelvic floor power, minimum and maximum muscle contraction values
timeFrame: 5 minutes
Secondary outcomes:
measure: DETAILED STORIES OF THE PATIENTS
timeFrame: 5 minutes
measure: Pelvic Floor Health Knowledge Test:
timeFrame: 5 minutes
measure: Global Pelvic Floor Disorder Questionnaire(GPFDQ)
timeFrame: 5 minutes
measure: Visual Analog Scale (VAS) assessment for pelvic pain
timeFrame: 1 minute
measure: Determining the severity of incontinence
timeFrame: 1 minute
measure: Sensory Evaluation
timeFrame: 1 minute
measure: Pelvic Floor Reflex Evaluation:
timeFrame: 1 minute
measure: Evaluation of Mistakes Made During Pelvic Floor Muscle Contraction
timeFrame: 5 minutes
measure: Pelvic organ prolapse evaluation
timeFrame: 1 minute
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe Universty
name: Türkan Akbayrak, Prof
role: STUDY_DIRECTOR
References: