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Electrostimulation and PFMT for Stress Urinary Incontinence

Primary Purpose

Urinary Incontinence, Stress

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Pelvic floor muscle exercises
Sponsored by
Lithuanian Sports University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring stress incontinence, pelvic floor, electrostimulation, muscle training

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lithuanian Sports University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pelvic floor muscle training group

Pelvic floor muscle electrostimulation group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Resting vaginal pressure
Perineometry with Pelvexiser perineometer (mm Hg).

Secondary Outcome Measures

Full Information

First Posted
April 12, 2023
Last Updated
May 22, 2023
Sponsor
Lithuanian Sports University
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1. Study Identification

Unique Protocol Identification Number
NCT05871281
Brief Title
Electrostimulation and PFMT for Stress Urinary Incontinence
Official Title
Effects of Pelvic Floor Muscle Training and Electrostimulation on Women's Quality of Life and Pelvic Floor Muscle Function in Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lithuanian Sports University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
stress incontinence, pelvic floor, electrostimulation, muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a four week, single blinded randomized controlled trial with pre-post design comparing PFM training group with PFM electrostimulation
Masking
Outcomes Assessor
Masking Description
outcomes were measured by gynecologists, intervention done by physiotherapist, who did not know measurements' results
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor muscle training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pelvic floor muscle electrostimulation group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor muscle exercises
Intervention Description
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 Outcome Measure Information:
Title
Quality of life by International Incontinence Counseling Questionnaire - Short Form (ICIQ - SF)
Description
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.
Time Frame
Change from Baseline Quality of Life at 4 weeks
Title
Pelvic floor muscle strength and endurance
Description
Perineometry with Pelvexiser perineometer (mm Hg). The higher the results- the better function of pelvic floor muscle strength and endurance.
Time Frame
Change from Baseline Pelvic floor Muscle Strength and Endurance at 4 weeks
Title
Resting vaginal pressure
Description
Perineometry with Pelvexiser perineometer (mm Hg).
Time Frame
Change from Baseline Resting Vaginal Prressure at 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women after delivery
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Dudoniene, PhD
Organizational Affiliation
Lithuanian Sports University, Lithuania
Official's Role
Study Chair
Facility Information:
Facility Name
Lithuanian Sports University
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD can not be shared according to signed by participants consent form.

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Electrostimulation and PFMT for Stress Urinary Incontinence

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