Urinary Incontinence, Stress
Conditions
Keywords
stress incontinence, pelvic floor, electrostimulation, muscle training
Brief summary
The goal of this randomized controlled trial is to evaluate and compare the effects of electrostimulation in addition to pelvic floor muscle training and pelvic floor muscle training alone on pelvic floor muscle (PFM) function, urinary incontinence and quality of life in women with stress urinary incontinence. The main questions are: What is the effect of electrostimulation combined with pelvic floor muscle training 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 - electrostimulation with pelvic floor muscle training or pelvic floor muscle training alone? Participants will be evaluated before and after the interventions with the following methods: International Incontinence Counseling Questionnaire - Short Form (ICIQ-SF) Pelvic floor muscle strength and endurance will be assessed with a Pelvexiser perineometer.
Detailed description
The study involved 24 women 20-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave at least one birth vaginally and signed the consent form. Subjects were excluded if they were pregnant, were diagnosed with vaginismus, urinary tract infections, cancer, epilepsy, pelvic organ prolapse greater than stage I, skin diseases, had undergone previous pelvic floor surgeries, had heart stimulator, or metal implant and were unable to contract the PFM. Study participants were randomly divided into two groups: the I group (n=12), in which participants underwent pelvic floor muscle training (PFMT) and the II group (n=12) in which subjects received pelvic floor muscle exercises combined with electrostimulation (PFMES).Participants were evaluated before the interventions and repeated after 4 weeks. Before and after the interventions, women's quality of life (QoL) was assessed according to the International Incontinence Counseling Questionnaire - Short Form. Perineometry with Pelvexiser perineometer was used to measure pelvic floor muscle strength and endurance and vaginal resting pressure. Statistical analysis was performed by IBM SPSS Statistics 26.0 and Microsoft Excel software 365.
Interventions
PROCEDUREPelvic floor muscle exercises
Pelvic floor muscle exercises were performed from different body positions. Duration of interventions - 4 weeks. Frequency - 2 times per week, number of individual contact sessions - 8 .
Sponsors
Lithuanian Sports University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
outcomes were measured by gynecologists, intervention done by physiotherapist, who did not know measurements' results
Intervention model description
This study is a four week, single blinded randomized controlled trial with pre-post design comparing PFM training group with PFM electrostimulation
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Have given birth at least once * Voluntary consent to participate in the study * Do not have concomitant diseases * Do not use hormonal drugs.
Exclusion criteria
* Less than three months have passed after childbirth * Have heart implants or other metal implants * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF) | Change from Baseline Quality of Life at 4 weeks | The questionnaire consists of four items and the overall score ranges from 0 to 21, with greater values indicating increased symptom severity: 0 - no symptoms of UI, 1-5 scores - mild symptoms of UI, 6-12 scores - moderate symptoms of UI, 13-18 scores - severe symptoms of UI, 19 - 21 scores - and very severe symptoms of UI. |
| Pelvic floor muscle strength and endurance | Change from Baseline Pelvic floor Muscle Strength and Endurance at 4 weeks | Perineometry with Pelvexiser perineometer (mm Hg). The higher the results- the better function of pelvic floor muscle strength and endurance. |
| Resting vaginal pressure | Change from Baseline Resting Vaginal Prressure at 4 weeks | Perineometry with Pelvexiser perineometer (mm Hg). |
Countries
Lithuania
Outcome results
None listed