Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792125
• Other study ID #: 2019-55
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: April 27, 2020

Study information

• Verified date: March 2021
• Source: Giresun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Giresun University	Giresun

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Huebner M, Riegel K, Hinninghofen H, Wallwiener D, Tunn R, Reisenauer C. Pelvic floor muscle training for stress urinary incontinence: a randomized, controlled trial comparing different conservative therapies. Physiother Res Int. 2011 Sep;16(3):133-40. do — View Citation

Kaya S, Akbayrak T, Gursen C, Beksac S. Short-term effect of adding pelvic floor muscle training to bladder training for female urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2015 Feb;26(2):285-93. doi: 10.1007/s00192-014-2517-4. E — View Citation

Turkan A, Inci Y, Fazli D. The short-term effects of physical therapy in different intensities of urodynamic stress incontinence. Gynecol Obstet Invest. 2005;59(1):43-8. Epub 2004 Sep 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported improvement	Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured).	8 weeks
Secondary	24 hour pad test	Urinary incontinence severity was assessed.	8 weeks
Secondary	pelvic floor muscle strength and endurance	measured using noninvasive vaginal perineometer	8 weeks