Clinical trial NCT06800222: Effectiveness of Modern Physical Agents in the Treatment of Pelvic Floor Dysfunctions
Official title: The Effectiveness of Modern Physical Agents in Treating Pelvic Floor Dysfunctions, Improving Functional State, Life Quality, and Biosocial Functions During First-stage Pelvic Rehabilitation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pelvic Floor Dysfunctions
Keywords: pelvic floor dysfunctions
pelvic pain
urgency
incontinece
vaginismus
constipation
erectile dysfunction
irritable bladder
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

The PMR physician will conduct thorough functional assessments again after rehabilitation and after six months.

Methods to assess functioning and pelvic floor dysfunctions:

Before rehabilitation:

Detailed questioning regarding the history of pelvic floor dysfunction, other treatments received, general health, and relevant psychosocial factors will precede setting an individualized rehabilitation plan for pelvic floor dysfunctions. The four-item patient health questionnaire for anxiety and depression ( PHQ-4 ) will be used when indicated. Subjects may be asked to fill out a 3-day bladder diary, a diary on bowel incontinence events, a male patients' diary on erection/ejaculation quality and satisfaction with sexual activity, or a pain questionnaire covering pain diagrams and intensity assessments, questions on pain quality, duration, and exacerbation/or alleviation factors, and changes over time.

A trained PMR physician will conduct a thorough clinical examination (including posture, perineum, and digital external and internal pelvic floor muscle assessment) and, when possible, functional testing of slow and quick muscle fibers endurance.

Functional assessment of the abdominal wall (for diastasis, abdominal muscle activity during a curl-up task, straight leg raise task) and pelvic floor muscle morphological and functional evaluation will be performed using two and three-dimensional (2D/3D) ultrasound (transabdominal and transperineal).

After rehabilitation:

To assess subjective experiences and attitudes towards received outpatient rehabilitation, all subjects will complete a self-reported questionnaire about symptom improvement based on global improvement rating scales. The questionnaire will also contain open-ended questions about patient expectations, experiences with learned self-help techniques, attitudes, and suggestions for the rehabilitation team regarding pelvic floor dysfunction rehabilitation. Subjects will rate the perceived helpfulness of each received rehabilitative intervention on a numeric 0-10 scale (where 0 is 'not helpful at all' and 10 is 'maximally helpful').

A thorough clinical examination (including perineum, digital external and internal pelvic floor muscle assessment) and, when possible, functional testing of slow and quick muscle fibers endurance will be conducted by a trained PMR physician.

Functional assessment of the abdominal wall (for diastasis), abdominal muscles, and pelvic floor muscle morphological and functional evaluation will be performed using 2D/3D ultrasound (transabdominal and transperineal).

When indicated (depending on symptoms and dysfunctions), subjects may be asked to fill out a 3-day bladder diary, a pain questionnaire, or diaries on bowel incontinence events and male sexual function.

The PHQ-4 will be used.

After six months:

detailed questionnaire on changes in pelvic floor dysfunction symptoms post-rehabilitation, other treatments received, general health, and other psychosocial factors will be conducted by a PMR physician to determine if further rehabilitation interventions are necessary. When indicated, subjects may be asked to fill out a 3-day bladder diary, a pain questionnaire, or other condition-specific diaries.

The PHQ-4 will be used for all subjects. A thorough clinical examination (including perineum, digital external and internal pelvic floor muscle assessment) and, when possible, functional testing of slow and quick muscle fibers endurance will be conducted by a trained PMR physician.

Functional assessment of the abdominal wall (for diastasis), abdominal muscles, and pelvic floor muscle

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years old.
2. 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.
3. Not a single exclusion criterion has been established.
4. Subjects capable of signing informed consent.

Exclusion Criteria:

1. Oncological diseases or being actively investigated for oncological diseases.
2. Any contraindications to methods of functional state examination or physical agents in the pelvic area that will be used in the study
3. Individuals who refuse a detailed clinical examination of the perineum and pelvic floor muscles, functional testing, and/or functional ultrasound examination.
4. Patients with urinary tract, prostate, genital, and other infections.
5. Patients with inflammatory bowel diseases (ulcerative colitis, Crohn's disease, etc.).
6. 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.
7. Pregnant or planning to become pregnant during the expected period of rehabilitation interventions.

Primary outcomes:
measure: Overall change in bothering pelvic floor symptoms according to Global Rating of Change (GRC) scales
timeFrame: 3 months
Secondary outcomes:
measure: Overall change in urinary dysfunction symptoms
timeFrame: 3 months and 6 months
measure: Overall change in fecal incontinence
timeFrame: 3 months and 6 months
measure: Overall change in pelvic pain
timeFrame: 3 months and 6 months
measure: Overall change in male sexual function
timeFrame: 3 months and 6 months
measure: Change in pelvic floor muscle contraction: ability to contract and relax pelvic floor muscles
timeFrame: 3 months and 6 months
measure: Change in pelvic floor painfulness from palpation
timeFrame: 3 months and 6 months
measure: Change in pelvic floor muscle endurance
timeFrame: 3 months and 6 months
measure: Change in pelvic floor muscle strenght
timeFrame: 3 months and 6 months
measure: Change in diastasis recti
timeFrame: 3 months and 6 months
measure: Change in vestibular painfulness
timeFrame: 3 months and 6 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Throughout rehabilitation and at 3 months and 6 months
measure: Individual subjects perceptions regarding the helpfulness of the rehabilitation interventions in reducing pelvic floor dysfunction symptoms and enhancing overall functioning
timeFrame: 3 months
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
state: Kauno M. Sav.
Study officials:
References: