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Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

Primary Purpose

Urinary Incontinence, Stress, Electrical Stimulation, Pelvic Floor Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)
External electrical stimulation
Pelvic floor muscle training (PFMT)
Sponsored by
Giresun University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Giresun University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Active Comparator

Arm Label

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

External electrical stimulation (EES) group

Pelvic floor muscle training (PFMT) group

Arm Description

This arm is going to include the patients who are performed external electrical stimulation (EES) added to pelvic floor muscle training (PFMT).

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

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

Outcomes

Primary Outcome Measures

Self-reported improvement
Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured).

Secondary Outcome Measures

24 hour pad test
Urinary incontinence severity was assessed.
pelvic floor muscle strength and endurance
measured using noninvasive vaginal perineometer

Full Information

First Posted
February 28, 2021
Last Updated
March 9, 2021
Sponsor
Giresun University
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1. Study Identification

Unique Protocol Identification Number
NCT04792125
Brief Title
Effect of External Electrical Stimulation and Pelvic Floor Muscle Training
Official Title
The Effects of External Electrical Stimulation Added to Pelvic Floor Muscle Training in Women With Stress Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Giresun University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress, Electrical Stimulation, Pelvic Floor Disorders, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External electrical stimulation (EES) added to pelvic floor muscle training (PFMT) group
Arm Type
Experimental
Arm Description
This arm is going to include the patients who are performed external electrical stimulation (EES) added to pelvic floor muscle training (PFMT).
Arm Title
External electrical stimulation (EES) group
Arm Type
Other
Arm Description
This arm is going to include the patients who are performed external electrical stimulation (EES).
Arm Title
Pelvic floor muscle training (PFMT) group
Arm Type
Active Comparator
Arm Description
This arm is going to include the patients who are performed pelvic floor muscle training (PFMT).
Intervention Type
Behavioral
Intervention Name(s)
External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)
Intervention Description
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
Intervention Name(s)
External electrical stimulation
Intervention Description
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
Intervention Name(s)
Pelvic floor muscle training (PFMT)
Intervention Description
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 Outcome Measure Information:
Title
Self-reported improvement
Description
Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
24 hour pad test
Description
Urinary incontinence severity was assessed.
Time Frame
8 weeks
Title
pelvic floor muscle strength and endurance
Description
measured using noninvasive vaginal perineometer
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ULKU K SAHIN, PhD
Organizational Affiliation
Giresun University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Giresun University
City
Giresun
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
25266357
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. Epub 2014 Sep 30.
Results Reference
result
PubMed Identifier
15459518
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. doi: 10.1159/000081133. Epub 2004 Sep 29.
Results Reference
result
PubMed Identifier
20848671
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/31270846/
Available IPD/Information Identifier
31270846
Available IPD/Information Comments
External electrical stimulation compared with intravaginal electrical stimulation for the treatment of stress urinary incontinence in women: A randomized controlled noninferiority trial

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Effect of External Electrical Stimulation and Pelvic Floor Muscle Training

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