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

NCT06800222 | Not Yet Recruiting DMC

• 1 other identifier: P-02 V-3
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Dysfunctions

Keywords

pelvic floor dysfunctions; pelvic pain; urgency; incontinece; vaginismus; constipation; erectile dysfunction; irritable bladder

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (12)

• Overall change in urinary dysfunction symptoms

  3 months and 6 months

• Overall change in fecal incontinence

  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 contraction: ability to contract and relax pelvic floor muscles

  3 months and 6 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Subjects will receive classical rehabilitation interventions together with modern physical agents

Other: modern agents rehab

Control

OTHER

subject will receive only classical rehabilitation interventions

Other: classical rehab

Interventions

modern agents rehab OTHER

rehabilitation interventions containing modern physical agents together with classical interventions

Intervention group

classical rehab OTHER

classical rehabilitation interventions

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects capable of signing informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Kauno M. Sav., 50161, Lithuania

Location

MeSH Terms

Conditions

Pelvic Pain; Vaginismus; Constipation; Erectile Dysfunction; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Signs and Symptoms, Digestive; Genital Diseases, Male; Male Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Central Study Contacts

Venta Donec Donec, PhD

CONTACT

+37069887316; Venta.donec@lsmu.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical medicine and rehabilitation physichian, Phd

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: January 29, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 9, 2028
• Study Completion (Estimated): September 9, 2029
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)