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Clinical Trials/NCT05871281
NCT05871281
Completed
Not Applicable

Effects of Pelvic Floor Muscle Training and Electrostimulation on Women's Quality of Life and Pelvic Floor Muscle Function in Stress Urinary Incontinence

Lithuanian Sports University1 site in 1 country24 target enrollmentJanuary 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Incontinence, Stress
Sponsor
Lithuanian Sports University
Enrollment
24
Locations
1
Primary Endpoint
Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2022
End Date
January 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)

Time Frame: 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.

Resting vaginal pressure

Time Frame: Change from Baseline Resting Vaginal Prressure at 4 weeks

Perineometry with Pelvexiser perineometer (mm Hg).

Pelvic floor muscle strength and endurance

Time Frame: 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.

Study Sites (1)

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