Physiotherapy in Stress Urinary Incontinence

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 29 to 49 years
• Women only
• Healthy volunteers accepted
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Urinary Incontinence,Stress

Being tested

functional magnetic stimulation, pelvic floor muscle training program

Keywords

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

Medical subject headings

Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• functional magnetic stimulationOther

  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 programOther

  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).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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).

   Measured: Change from Baseline Urinary Incontinence symptoms at 6 weeks

2. 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.

   Measured: Change from Baseline Incontinence Impact Questionnaire scores at 6 weeks

3. 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).

   Measured: Change from Baseline Perineometry at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Feb 2023
2. Study start7 Jul 2021
3. Primary completion30 Oct 2021
4. Study completion30 Oct 2021

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Urinary Incontinence,StressStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.