Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

March 9, 2021 updated by: Ulkukezbansahin, Giresun University

The Effects of External Electrical Stimulation Added to Pelvic Floor Muscle Training in Women With Stress Incontinence

In this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty one women with mild and moderate SUI symptoms were included in the study. The patients were divided into three groups of PFMT (n:17), EES (n:17) and PFMT+ EES (n:17) by block randomization. The PFMT was applied every day of the week, and EES was applied 3 days a week for 8 weeks. Pelvic floor muscle strength (PFMS), pelvic floor muscle endurance, subjective perception of improvement, severity of incontinence, quality of life, pelvic floor dysfunction (PTD) and urinary parameters were assessed as outcome variables. All measurements, except subjective perception of improvement were investigated before and after treatment.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Giresun, Turkey
        • Giresun University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • having symptoms of pure stress urinary incontinence and stress predominant UI
  • ability to contract pelvic floor muscle strength
  • Having a mild or moderate SUI symptom according to the 24-hour pad test results.

Exclusion Criteria:

  • Pregnancy,
  • Having been treated for incontinence within a period of six months ago,
  • Not being able to cooperate,
  • Presence of urinary infection
  • Use of metal implants or cardiac pacemakers,
  • Epilepsy,
  • Presence of stage 3 or 4 pelvic organ prolapse,
  • Presence of accompanying neurological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) group
This arm is going to include the patients who are performed external electrical stimulation (EES) added to pelvic floor muscle training (PFMT).
Behavioral: External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)

Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.

While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.
OTHER: External electrical stimulation (EES) group
This arm is going to include the patients who are performed external electrical stimulation (EES).
Behavioral: External electrical stimulation
Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.
ACTIVE_COMPARATOR: Pelvic floor muscle training (PFMT) group
This arm is going to include the patients who are performed pelvic floor muscle training (PFMT).
Behavioral: Pelvic floor muscle training (PFMT)
While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported improvement
Time Frame: 8 weeks
Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hour pad test
Time Frame: 8 weeks
Urinary incontinence severity was assessed.
8 weeks
pelvic floor muscle strength and endurance
Time Frame: 8 weeks
measured using noninvasive vaginal perineometer
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Investigators

  • Principal Investigator: ULKU K SAHIN, PhD, Giresun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 29, 2019

Primary Completion (ACTUAL)

April 27, 2020

Study Completion (ACTUAL)

April 27, 2020

Study Registration Dates

First Submitted

February 28, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (ACTUAL)

March 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.

Study Data/Documents

  1. Study Protocol
    Information identifier: 31270846
    Information comments: External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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