Electrostimulation and PFMT for Stress Urinary Incontinence

NCT05871281 | Completed

• 1 other identifier: LithuanianSportsU 14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Stress

Keywords

stress incontinence; pelvic floor; electrostimulation; muscle training

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Pelvic floor muscle training group

ACTIVE COMPARATOR

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 electrostimulation group

EXPERIMENTAL

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

Interventions

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 .

Pelvic floor muscle electrostimulation group; Pelvic floor muscle training group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Women after delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have given birth at least once
• Voluntary consent to participate in the study
• Do not have concomitant diseases
• Do not use hormonal drugs.

You may not qualify if:

• Less than three months have passed after childbirth
• Have heart implants or other metal implants
• Pregnancy

Sponsors & Collaborators

• Lithuanian Sports University: lead

Study Sites (1)

Lithuanian Sports University

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

• Vilma Dudoniene, PhD

  Lithuanian Sports University, Lithuania

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes were measured by gynecologists, intervention done by physiotherapist, who did not know measurements' results
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a four week, single blinded randomized controlled trial with pre-post design comparing PFM training group with PFM electrostimulation

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 23, 2023
• Study Start: January 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)