Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

NCT04792125 | Completed

• 1 other identifier: 2019-55
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 24 hour pad test

  8 weeks

• pelvic floor muscle strength and endurance

  8 weeks

Study Arms (3)

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

EXPERIMENTAL

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)

External electrical stimulation (EES) group

OTHER

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

Behavioral: External electrical stimulation

Pelvic floor muscle training (PFMT) group

ACTIVE COMPARATOR

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

Behavioral: Pelvic floor muscle training (PFMT)

Interventions

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 (EES) added to pelvic floor muscle training (PFMT) group

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.

External electrical stimulation (EES) group

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.

Pelvic floor muscle training (PFMT) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun University

Giresun, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25266357 RESULT

• 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.

  PMID: 15459518 RESULT

• 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.

  PMID: 20848671 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pelvic Floor Disorders; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Study Officials

• ULKU K SAHIN, PhD

  Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 10, 2021
• Study Start: April 29, 2019
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)