About this trial
This clinical trial aims to determine whether adding modern physical agents (high-intensity laser therapy, magnetotherapy, radial shock wave therapy, kinesiotaping) in conjunction with classical rehabilitation interventions produces superior outcomes in treating pelvic floor dysfunction compared to classical rehabilitation interventions alone. It will also assess the safety of these agents in the context of pelvic floor dysfunction rehabilitation. The main questions it aims to answer are:
Does adding modern physical agents to the treatment of pelvic floor dysfunction improve symptoms, impairments in functional state, quality of life, and biosocial functions more effectively than classical interventions alone?
Participants who experience pelvic floor dysfunction during primary rehabilitation will receive:
Either an individualized rehabilitation intervention plan comprising 20 classical procedures in combination with modern physical agents or classical interventions alone. Rehabilitation will take place in the outpatient rehabilitation department. Patients will visit the clinic for a comprehensive functional state assessment and then for individualized procedures; the entire plan will be delivered over three months, after which participants will return for follow-up checkups and assessments after the procedures and again after six months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients older than 18 years old.
One or more signs characteristic of pelvic floor dysfunctions are identified: elimination function disorders, pelvic organ prolapse, scar(s) (and lack of tissue mobility) in the perineum, pelvic floor muscle tone/strength disorders (hypoactivity/hyperactivity), neuromuscular control disorders, sexual dysfunctions, pain in the pelvis, perineum.
Not a single exclusion criterion has been established.
Subjects capable of signing informed consent.
Disqualifiers
Oncological diseases or being actively investigated for oncological diseases.
Any contraindications to methods of functional state examination or physical agents in the pelvic area that will be used in the study
Individuals who refuse a detailed clinical examination of the perineum and pelvic floor muscles, functional testing, and/or functional ultrasound examination.
Patients with urinary tract, prostate, genital, and other infections.
Trial design
Parallel
Treatments tested in this trial
modern agents rehab
Other interventionrehabilitation interventions containing modern physical agents together with classical interventions
classical rehab
Other interventionclassical rehabilitation interventions
Treatment groups
Trial outcomes
Primary outcomes
Overall change in bothering pelvic floor symptoms according to Global Rating of Change (GRC) scales
After rehabilitation, the overall change in bothering pelvic floor dysfunction symptoms according to Global Rating of Change (GRC) scales will be assessed. The Global Rating of Change (GRC) Scale is a tool used to assess a patient's perceived change in health status over time. The minimum value is 0, indicating "no change." The maximum value is 10, indicating "a very great deal better." Higher scores on the GRC Scale reflect a better outcome, showing greater perceived improvement in the patient's symptoms.
Secondary outcomes
Overall change in urinary dysfunction symptoms
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.
Overall change in fecal incontinence
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.
Overall change in pelvic pain
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. 3\) Pain localization will be assessed using a pain diagram, allowing subjects to indicate where they experience pain by marking specific areas.
Overall change in male sexual function
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).
Sponsors and contacts
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