Clinical trial NCT05721807: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence,Stress
Keywords: stress incontinence
pelvic floor
functional magnetic stimulation
muscle training
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 48
Sex: FEMALE
Minimum age (years): 29
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Urinary incontinence symptoms and quality of life (International Consultation on Incontinence Questionnaire)
timeFrame: Change from Baseline Urinary Incontinence symptoms at 6 weeks
measure: IIQ-7 -Incontinence Impact Questionnaire
timeFrame: Change from Baseline Incontinence Impact Questionnaire scores at 6 weeks
measure: Perineometry
timeFrame: Change from Baseline Perineometry at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
affiliation: Lithuanian Sports University
name: Vilma Dudonienė
role: STUDY_CHAIR
References: