Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

NCT ID: NCT04792125

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2020-04-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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 (EES) group

This arm is going to include the patients who are performed external electrical stimulation (EES).

Group Type: OTHER

External electrical stimulation

Intervention Type: 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) group

This arm is going to include the patients who are performed pelvic floor muscle training (PFMT).

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training (PFMT)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Giresun University

OTHER

Sponsor Role: lead

Responsible Party

Ulkukezbansahin

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ULKU K SAHIN, PhD

Role: PRINCIPAL_INVESTIGATOR

Giresun University

Locations

Giresun University

Giresun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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. Epub 2014 Sep 30.

Reference Type: RESULT

PMID: 25266357 (View on PubMed)

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. doi: 10.1159/000081133. Epub 2004 Sep 29.

Reference Type: RESULT

PMID: 15459518 (View on PubMed)

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. doi: 10.1002/pri.489. Epub 2010 Sep 16.

Reference Type: RESULT

PMID: 20848671 (View on PubMed)

Study Documents

Document Type: Study Protocol

External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial

View Document

Other Identifiers

2019-55

Identifier Type: -

Identifier Source: org_study_id