Effectiveness of Modern Physical Agents in the Treatment of Pelvic Floor Dysfunctions

The overall change in urgency and incontinence symptoms (if applicable) will be assessed by 3-day bladder dairy after rehabilitation and at the follow-up.

A 3-day bladder diary is when, over three days, patients record details about their urinary habits, including the frequency and volume of urination, fluid intake, and any incontinence episodes. This diary helps healthcare providers assess lower urinary tract symptoms and develop appropriate treatment plans. Additionally, in this study, diary data will help to monitor changes in minimal/maximum volume, average volume during urination, incontinence severity, and changes in incontinence episodes.

A diary of accidents will assess the overall change in fecal incontinence (if applicable).

Subjects will be asked to record each incontinence event and provide information about the frequency, timing, and possible triggers of incontinence episodes. This detailed record helps healthcare providers identify patterns, understand the severity of the condition, and develop personalized treatment plan to improve the quality of life. In this study, the diary will help to assess the overall change in fecal incontinence symptoms, frequency, and severity.

The overall change in pelvic pain (if applicable) will be assessed using a questionnaire with the following questions: 1) Pain intensity at different times and during various activities, such as day/night, walking, changing body positions, lying/sitting/standing, during sexual activity, urination, and defecation, as well as after sexual activity, urination, and defecation. This will be measured by the Numeric Pain Rating Scale (NPRS), where 0 indicates "no pain at all," and 10 indicates "worst imaginable pain." 2) Pain duration during the day/night, while walking, changing body positions, and while lying/sitting/standing, with possible answer choices: Constant (always the same intensity); Constant (pain intensity varies); Often felt (pain-free periods shorter than 6 hours); Intermittent; I did not feel pain.

1. Pain localization will be assessed using a pain diagram, allowing subjects to indicate where they experience pain by marking specific areas.

If applicable, changes in male sexual function will be assessed through a self-evaluation diary that subjects experiencing sexual dysfunction will be asked to fill out during participation. In this diary, subjects will need to self-report events of sexual activity (intercourse or masturbation), its duration, the dominant body position, the quality of erection during sexual activity as a percentage, where 0% indicates no erection at all (flaccid penis), 50% erection is sufficient for vaginal penetration, and 100% erection is a maximally hard penis (maximum erection). They will also evaluate the quality of ejaculation during sexual activity with possible options: failed to ejaculate, premature ejaculation, delayed ejaculation, or good (normal, timely) ejaculation. Subjects will report overall pleasure achieved with the activity on a scale from 0-100% (0 indicating no satisfaction at all, 100% indicating maximal satisfaction/pleasure).

ability to contract and relax pelvic floor muscles (voluntary and non-voluntary) will be assessed clinicaly through inspection and palpation following the recomendations of International Continence Society for pelvic floor clinical assessment. Additionally voluntary and non-voluntry contraction/relaxation will be assessed through functional ultrasound (visualizing the contractions and relaxation) as well as measuring the changes in levator ani anteriorposterior line distance during efforts to provoke voluntary and non-voluntary (cough test/straining) contraction and relaxation. The Levator ani anterior-posterior distance with ultrasound will be measured transperinealy from a defined anterior point (the pubic symphysis) to a posterior point (the anorectal junction), measured in milimeters.

During clinical palpation of the pelvic floor, subjects will be asked to indicate if they feel any pain and to specify its intensity on the Numeric Pain Rating Scale (NPRS) (0 = no pain at all, 10 = worst imaginable pain). The anatomical areas where tissues are painful to palpation and the pain intensity will be documented in the assessment protocol.

If applicable, pelvic floor muscle endurance will be assessed through clinical examination as suggested by the International Continence Society. Endurance is expressed as the length of time, up to 10 seconds, that maximal voluntary contractions of the pelvic floor muscles can be sustained before strength is reduced by 35% or more. The number of repetitions (up to 10) of maximal voluntary contractions will then be recorded, allowing four seconds of rest between each contraction. After a one-minute rest, the number (up to 15) of one-second maximal voluntary contractions will be assessed.

Pelvic floor muscle strength will be assessed clinically by a modified Oxford scale. (MOS). The MOS is used to rate pelvic floor muscle contractility on a scale of 0-5: 0, no contraction; 1, minor muscle 'flicker'; 2, weak muscle contraction without a circular contraction; 3, moderate muscle contraction; 4, good muscle contraction; and 5, strong muscle contraction against resistance by the examining finger. Additionally (if applicable), women will undergo 3D transperineal functional ultrasound testing. The reduction in hiatal area (in square mm) and anteroposterior diameter (mm) during maximal induced pelvic floor muscle contraction will be measured, and the percentage change will be identified. The formula for counting the change will be: difference = ((Measurement at rest - Measurement at squeeze/straining )/Measurement at rest ) × 100%. If signs of levator ani avulsion or hiatal ballooning, asymmetry in contraction is notified, this will be noted in the assessment protocol.

If applicable (in cases of diastasis recti), the inter-rectus distance (IRD) change after rehabilitation and at the 6-month follow-up will be measured with transabdominal ultrasound at four locations, with the subject lying on their back in a resting position: AU1: ½ of the superior umbilical border-xiphoid distance; AU2: ¼ of the superior umbilical border-xiphoid distance; U: the superior umbilical border; BU: ¼ of the superior umbilical border-pubis distance. The change in percentage from the measured values before rehabilitation will be calculated using the formula: ((IRD in mm {baseline measurement} - IRD in mm{following measurement}) / IRD in mm {baseline measurement} * 100%). The ultrasound diagnostic criteria we will use for diagnosing diastasis recti are a distance of more than 22 mm for AU1, AU2, and U points, and a distance of more than 16 mm for the BU point.

In cases of vestibular painfulness, light touches with a cotton swab will be performed during the clinical examination on specific points of the vestibular area to determine tender points. The evoked pain will be rated using the Numeric Pain Rating Scale (NPRS), where 0 indicates no pain at all, and 10 indicates the worst imaginable pain. Additionally, the subject will be asked to rate the pain following slow and gentle glowed and lubricated index finger insertion into the vagina to assess the pain intensity associated with finger penetration using the NPRS. The change in pain intensity will be calculated by comparing the initial pain intensity (0-10 points) with the pain intensity after rehabilitation and at follow-up.

The rehabilitation team members will monitor treatment-related adverse events throughout the rehabilitation process. Subjects will also be encouraged to report any adverse effects or complications they experience during treatment.

Adverse events will be classified into five grades based on severity:

Grade 1 (Mild): Mild adverse events that are asymptomatic or only minimally symptomatic. Grade 2 (Moderate): Moderate adverse events that may cause discomfort but do not significantly interfere with daily activities.

Grade 3 (Severe): Severe adverse events that are medically significant and may require hospitalization or significant intervention. Grade 4 (Life-threatening): Life-threatening adverse events that pose an immediate risk to life.

Grade 5 (Death): Adverse events that result in death.

After the rehabilitation, all subjects will be asked to complete a self-reported questionnaire containing close-ended questions, open-ended questions, and global 11-point rating scales (where 0 represents "the specified rehabilitation intervention was not helpful at all," and 10 indicates "maximally helpful"). This questionnaire will assess their individual experiences and attitudes concerning the rehabilitation interventions received and their perceived rehabilitation helpfulness in reducing pelvic floor dysfunctions and functioning impairments.