The Effectiveness of Modern Physical Agents in Treating Pelvic Floor Dysfunctions, Improving Functional State, Life Quality, and Biosocial Functions During First-stage Pelvic Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Overall change in bothering pelvic floor symptoms according to Global Rating of Change (GRC) scales
研究概览
简要总结
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.
详细描述
After subjects are included in the research, two groups (interventional-modern agents rehab and control-classical rehab) of 125 patients each will be formed through concealed randomization. A person not connected with the study will use a random number generator to allocate subjects to the groups.
The rehabilitation process for all subjects will include a comprehensive functional assessment, setting short-term and long-term individualized goals for each subject, prescribing and implementing a primary outpatient rehabilitation plan involving various rehabilitative interventions. Once the plan is implemented, the physical medicine and rehabilitation (PMR) physician will thoroughly assess the rehabilitation results. An observation period will follow, during which learned self-help techniques will be integrated into daily life. After six months, all subjects will be reassessed by a PMR physician.
Process:
After inclusion, all participants will be thoroughly assessed by a qualified PMR physician specializing in pelvic floor dysfunction rehabilitation. Following all functional assessments, an individualized primary outpatient rehabilitation plan will be agreed upon with the patient, comprising 20 rehabilitative interventions. Depending on the group to which the subject is randomized, the individualized rehabilitation interventions will either consist of classical interventions (such as physiotherapy, occupational therapy, electrical stimulation, etc.) for the control group, or classical interventions combined with modern physical agents for the interventional group.
During the rehabilitation period, the rehabilitation team will monitor subjects in both groups for any side effects from the rehabilitation interventions. Subjects will also have the option to inform and consult a PMR physician as often as needed in case of side effects or intolerance to prescribed interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Patients with inflammatory bowel diseases (ulcerative colitis, Crohn's disease, etc.).
- •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.
结局指标
主要结局
Overall change in bothering pelvic floor symptoms according to Global Rating of Change (GRC) scales
时间窗: 3 months
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.
次要结局
- Overall change in urinary dysfunction symptoms(3 months and 6 months)
- Overall change in fecal incontinence(3 months and 6 months)
- Change in pelvic floor muscle contraction: ability to contract and relax pelvic floor muscles(3 months and 6 months)
- Change in pelvic floor painfulness from palpation(3 months and 6 months)
- Change in pelvic floor muscle endurance(3 months and 6 months)
- Overall change in pelvic pain(3 months and 6 months)
- Overall change in male sexual function(3 months and 6 months)
- Change in pelvic floor muscle strenght(3 months and 6 months)
- Change in diastasis recti(3 months and 6 months)
- Change in vestibular painfulness(3 months and 6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(Throughout rehabilitation and at 3 months and 6 months)
- Individual subjects perceptions regarding the helpfulness of the rehabilitation interventions in reducing pelvic floor dysfunction symptoms and enhancing overall functioning(3 months)
研究者
Venta Donec
Physical medicine and rehabilitation physichian, Phd
Lithuanian University of Health Sciences