Effectiveness of Modern Physical Agents in the Treatment of Pelvic Floor Dysfunctions (NCT06800222) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Modern Physical Agents in the Treatment of Pelvic Floor Dysfunctions
Lithuania250 participantsStarted 2025-03-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Subjects capable of signing informed consent.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall change in bothering pelvic floor symptoms according to Global Rating of Change (GRC) scales
. 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.
. Persons for whom other health care professionals have already planned treatment of pelvic dysfunctions or other diseases during the expected participation period in the study that may interfere with participation in the study and/or significantly change the health status of the patient's pelvic floor.
. Pregnant or planning to become pregnant during the expected period of rehabilitation interventions.