Physiotherapy in Stress Urinary Incontinence
Primary Purpose
Urinary Incontinence,Stress
Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
functional magnetic stimulation
pelvic floor muscle training program
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence,Stress focused on measuring stress incontinence, pelvic floor, functional magnetic stimulation, muscle training
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.
Sites / Locations
- Lithuanian Sports University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
functional magnetic stimulation
pelvic floor muscle training program
Arm Description
functional magnetic stimulation for stress urinary incontinence
exercise program for pelvic floor muscle
Outcomes
Primary Outcome Measures
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).
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05721807
First Posted
January 19, 2023
Last Updated
April 19, 2023
Sponsor
Lithuanian Sports University
1. Study Identification
Unique Protocol Identification Number
NCT05721807
Brief Title
Physiotherapy in Stress Urinary Incontinence
Official Title
Effectiveness 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lithuanian Sports University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence,Stress
Keywords
stress incontinence, pelvic floor, functional magnetic stimulation, muscle training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
functional magnetic stimulation
Arm Type
Experimental
Arm Description
functional magnetic stimulation for stress urinary incontinence
Arm Title
pelvic floor muscle training program
Arm Type
Experimental
Arm Description
exercise program for pelvic floor muscle
Intervention Type
Other
Intervention Name(s)
functional magnetic stimulation
Intervention Description
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
Intervention Name(s)
pelvic floor muscle training program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Urinary incontinence symptoms and quality of life (International Consultation on Incontinence Questionnaire)
Description
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).
Time Frame
Change from Baseline Urinary Incontinence symptoms at 6 weeks
Title
IIQ-7 -Incontinence Impact Questionnaire
Description
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.
Time Frame
Change from Baseline Incontinence Impact Questionnaire scores at 6 weeks
Title
Perineometry
Description
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).
Time Frame
Change from Baseline Perineometry at 6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Dudonienė
Organizational Affiliation
Lithuanian Sports University
Official's Role
Study Chair
Facility Information:
Facility Name
Lithuanian Sports University
City
Kaunas
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
No
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Physiotherapy in Stress Urinary Incontinence
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