Physiotherapy in Stress Urinary Incontinence

NCT05721807 | Completed

• 1 other identifier: LithuanianSportsU-13
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence,Stress

Keywords

stress incontinence; pelvic floor; functional magnetic stimulation; muscle training

Outcome Measures

Primary Outcomes (3)

• Urinary incontinence symptoms and quality of life (International Consultation on Incontinence Questionnaire)

  ICIQ - SF - International Consultation on Incontinence Questionnaire - Short Form is intended to subjectively evaluate the symptoms of urinary incontinence in a woman or man and the impact of those symptoms on the quality of life. The questionnaire consists of four questions. The first two questions assess the symptoms of urinary incontinence experienced, the third question describes quality of life and the fourth question determines which type of incontinence the person has. The scores of the first three questions are summed up, the maximum number of points collected is 21, the minimum is 0. Depending on the number of points collected, the severity of urinary incontinence symptoms is assessed: no urinary incontinence symptoms (0 points), mild urinary incontinence symptoms (1 - 5 points), moderate incontinence symptoms (score 6-12), severe incontinence symptoms (score 13-18) and very severe incontinence symptoms (19-21).

  Change from Baseline Urinary Incontinence symptoms at 6 weeks

• IIQ-7 -Incontinence Impact Questionnaire

  The IIQ-7 questionnaire is designed to assess the impact of urinary incontinence on quality of life. The questionnaire consists of seven questions, which can be answered to find out the impact of urinary incontinence on all areas of life: physical activity, traveling, social activity, relationships, emotional state. Each question is evaluated from 0 to 3 points. The higher the score, the worse the quality of life. The maximum number of collected points is 100, the minimum is 0. \<50 points is considered a good quality of life, 50-70 points is an average quality of life, \>70 points is a poor quality of life.

  Change from Baseline Incontinence Impact Questionnaire scores at 6 weeks

• Perineometry

  The strength and endurance of the subjects' pelvic floor muscles was assessed with a Pelvexiser perineometer (Wolfram Haboeck Co., Austria). This apparatus has been scientifically proven as an objective method of assessing the function of the pelvic floor muscles and an effective exerciser for strengthening the pelvic floor muscles, which is why it is often used in the presence of for urinary incontinence problems. The Pelvexiser can provide varying resistance to the pelvic floor muscles and provide real-time feedback on pelvic floor muscle contractions and changes (Chitra et al., 2010).

  Change from Baseline Perineometry at 6 weeks

Study Arms (2)

functional magnetic stimulation

EXPERIMENTAL

functional magnetic stimulation for stress urinary incontinence

Other: functional magnetic stimulation

pelvic floor muscle training program

EXPERIMENTAL

exercise program for pelvic floor muscle

Other: pelvic floor muscle training program

Interventions

functional magnetic stimulation 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).

functional magnetic stimulation

pelvic floor muscle training program 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).

pelvic floor muscle training program

Eligibility Criteria

• Age: 29 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lithuanian Sports University: lead

Study Sites (1)

Lithuanian Sports University

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vilma Dudonienė

  Lithuanian Sports University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 10, 2023
• Study Start: July 7, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)