Electrostimulation and PFMT for Stress Urinary Incontinence

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Procedure: Pelvic floor muscle exercises

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Lithuanian Sports University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pelvic floor muscle training group; All subjects attended individual physiotherapy procedures, the duration of one of which was 60 minutes. One woman was assigned a total of 8 contact procedures over four weeks. During the individual procedures, exercises were selected and modified according to the women's ability to perform them. All women were taught correct abdominal breathing while lying down, to activate the abdominal muscles. Also, all were trained to perform Kegel exercises, explaining their benefits. In order to diversify and modify the exercises, they were performed with auxiliary means, i.e. using balls, gymnastic sticks, a bench, elastic bands, a physiotherapy wall, yoga blocks, rollers, weights and an aerial yoga band.	Procedure: Pelvic 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 .
Experimental: Pelvic floor muscle electrostimulation group; Electrostimulation was performed with a Kegel 8 home elektrostymulator. The subjects were prescribed two electrostimulation programs: PO3 in the morning and PO10 in the evening. The duration of the PO3 program was 45 minutes, and was intended for general strengthening of the pelvic floor muscles. The duration of the PO10 program is 40 minutes. and it is prescribed for stress incontinence. Duration of interventions 4 week.	Procedure: Pelvic 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)	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.	Change from Baseline Quality of Life at 4 weeks
Pelvic floor muscle strength and endurance	Perineometry with Pelvexiser perineometer (mm Hg). The higher the results- the better function of pelvic floor muscle strength and endurance.	Change from Baseline Pelvic floor Muscle Strength and Endurance at 4 weeks
Resting vaginal pressure	Perineometry with Pelvexiser perineometer (mm Hg).	Change from Baseline Resting Vaginal Prressure at 4 weeks

Collaborators and Investigators

• Sponsor: Lithuanian Sports University
• Investigators: Study Chair: Vilma Dudoniene, PhD, Lithuanian Sports University, Lithuania

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pelvic floor; stress incontinence; electrostimulation; muscle training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: LithuanianSportsU 14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD can not be shared according to signed by participants consent form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No