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Completed

NCT Number: NCT05871281

Electrostimulation and PFMT for Stress Urinary Incontinence

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.

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Key information

Conditions

Urinary Incontinence, Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian Sports University

Kaunas, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pelvic floor muscle exercises

Procedure

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 .

Primary outcomes

  1. 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.

  2. 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.

  3. Resting vaginal pressure

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

    Perineometry with Pelvexiser perineometer (mm Hg).

Sponsors and collaborators

Lead sponsor

Lithuanian Sports University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 23, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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