Physiotherapy in Stress Urinary Incontinence

NCT ID: NCT05721807

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2021-10-30

Brief Summary

The goal of this randomized controlled trial is to evaluate and compare the effects of functional magnetic stimulation and pelvic floor muscle training on pelvic floor muscle function, urinary incontinence symptoms and quality of life in women with stress urinary incontinence. The main questions it aims to answer are:

• What is the effect of functional magnetic stimulation on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence?
• What is the effect of pelvic floor muscle training program on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence?
• Which intervention is more effective - functional magnetic stimulation or pelvic floor muscle training program?

Participants will be evaluated before and after the intervention with the following methods:

• International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF);
• Incontinence Impact Questionnaire-Short Form (IIQ-7);
• Pelvic floor muscle strength and endurance will be assessed with a "Pelvexiser" perineometer.

Detailed Description

The study was performed in the period of 07/21/2021-30/10/2021. The study included 48 women 29-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave birth and signed the consent form. Women complaining of vaginismus, suffering from urinary tract infection, cancer, epilepsy or skin conditions with implanted pacemakers, metal implants and pregnant women were excluded from the study. Study participants were randomly divided into two groups: the I group (n=24), in which participants underwent functional magnetic stimulation (FMS) and the II group (n=24) in which subjects received pelvic floor muscle training (PFMT) program. Participants were evaluated before the intervention and repeated after 6 weeks. Subjects responded to a general questionnaire before the intervention, before and after the intervention, the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and Incontinence Impact Questionnaire-Short Form (IIQ-7) were used to assess the symptoms of urinary incontinence and their impact on quality of life. Pelvic floor muscle strength and endurance were assessed with a "Pelvexiser" perineometer. Statistical analysis was performed by IBM SPSS Statistics 26.0 and Microsoft Excel software 365.

Conditions

Urinary Incontinence,Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

functional magnetic stimulation

functional magnetic stimulation for stress urinary incontinence

Group Type: EXPERIMENTAL

functional magnetic stimulation

Intervention Type: OTHER

When applying functional magnetic stimulation, the stress urinary incontinence program "P2 stress" was chosen. The first 20 min. current frequency was 35 Hz, modulation - rising amplitude (from 0 to maximum per second), total wave duration 12 s. active time 6 s., pause time 6 s. After 20 min. current frequency changed to 5 Hz, modulation and wave remained the same. After 2 min. current frequency changed to 35 Hz, modulation - amplitude, one-sided sinusoidal, wave remained the same. The total duration of the procedure was 30 min. A magnetic spring is installed at the bottom of the chair. During the treatment, each subject was instructed to sit on a chair so that the perineum was centered on the spring and that the subjects felt the contraction of the muscles. The intensity of the magnetic field was adjusted so as to feel comfortable during the study procedure (Vadalà et al., 2017).

pelvic floor muscle training program

exercise program for pelvic floor muscle

Group Type: EXPERIMENTAL

pelvic floor muscle training program

Intervention Type: OTHER

The program consisted of two parts. From procedures 1 to 6, 6 exercises were performed, after 6 times the exercises were adjusted, and from procedures 7 to 12, another 5 exercises were performed. The program consists of breathing, pelvic floor muscle strength, endurance, speed training exercises and exercises to strengthen the thighs, buttocks, deep back and deep abdominal muscles. Exercises were performed in 2 sets of 10 repetitions at an intensity from various positions: lying on the back, side, sitting, quadruped (Oliveira et al., 2017; Walton et al., 2019).

Interventions

functional magnetic stimulation

When applying functional magnetic stimulation, the stress urinary incontinence program "P2 stress" was chosen. The first 20 min. current frequency was 35 Hz, modulation - rising amplitude (from 0 to maximum per second), total wave duration 12 s. active time 6 s., pause time 6 s. After 20 min. current frequency changed to 5 Hz, modulation and wave remained the same. After 2 min. current frequency changed to 35 Hz, modulation - amplitude, one-sided sinusoidal, wave remained the same. The total duration of the procedure was 30 min. A magnetic spring is installed at the bottom of the chair. During the treatment, each subject was instructed to sit on a chair so that the perineum was centered on the spring and that the subjects felt the contraction of the muscles. The intensity of the magnetic field was adjusted so as to feel comfortable during the study procedure (Vadalà et al., 2017).

Intervention Type: OTHER

pelvic floor muscle training program

The program consisted of two parts. From procedures 1 to 6, 6 exercises were performed, after 6 times the exercises were adjusted, and from procedures 7 to 12, another 5 exercises were performed. The program consists of breathing, pelvic floor muscle strength, endurance, speed training exercises and exercises to strengthen the thighs, buttocks, deep back and deep abdominal muscles. Exercises were performed in 2 sets of 10 repetitions at an intensity from various positions: lying on the back, side, sitting, quadruped (Oliveira et al., 2017; Walton et al., 2019).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• complains of stress incontinence for at least 4 weeks;
• women who have given birth.

Exclusion Criteria

• pregnancy;
• vaginism;
• urinal infection;
• oncological disorders;
• epilepsy;
• skin problems;
• if they had an implanted heart pacemaker, metal implants.

• Minimum Eligible Age: 29 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lithuanian Sports University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vilma Dudonienė

Role: STUDY_CHAIR

Lithuanian Sports University

Locations

Lithuanian Sports University

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

LithuanianSportsU-13

Identifier Type: -

Identifier Source: org_study_id