NCT04792125

Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Giresun University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Urinary Incontinence, Stress
• Electrical Stimulation
• Pelvic Floor Disorders
• Urinary Incontinence

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2019-04-29
• Primary completion: 2020-04-27
• Completion: 2020-04-27
• First posted: 2021-03-10
• Last updated: 2021-03-10

Locations

1 site across 1 country: Turkey (Türkiye)