Electrostimulation and PFMT for Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Incontinence, Stress

• Registration Number: NCT05871281
• Lead Sponsor: Lithuanian Sports University

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.

Study Timeline

• Study Start: 2022-01-15
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Study First Submitted: 2023-04-12
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
Resting vaginal pressure	Change from Baseline Resting Vaginal Prressure at 4 weeks	Perineometry with Pelvexiser perineometer (mm Hg).
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.

Trial Locations

Locations (1)

Lithuanian Sports University; 🇱🇹 Kaunas, Lithuania