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Completed

NCT Number: NCT04792125

Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

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.

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Key information

Conditions

Urinary Incontinence, Stress Electrical Stimulation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pregnancy Complications Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Giresun University

Giresun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)

Behavioral

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.

External electrical stimulation

Behavioral

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.

Pelvic Floor Muscle Training (PFMT)

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 24 hour pad test

    Time frame: 8 weeks

    Urinary incontinence severity was assessed.

  2. pelvic floor muscle strength and endurance

    Time frame: 8 weeks

    measured using noninvasive vaginal perineometer

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 10, 2021
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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