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The Effect Of Pelvic Floor Muscle Training With Biofeedback And Extracorporeal Magnetic Innervation On The Urinary Symptoms, Sexual Function And Quality Of Life

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training With Biofeedback
Extracorporeal Magnetic Innervation
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence focused on measuring Stress urinary incontinence, quality of life, sexual function

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria

  • patients diagnosed with stress urinary incontinence
  • with pelvic floor power 2 and over,
  • sexually active and no restrictions for the magnetic chair treatment.

Exclusion Criteria:

patients with

  • prosthesis,
  • other implanted metallic devices,
  • cardiac pacemaker,
  • arrhythmia,
  • pelvic malignancies,
  • under radiotherapy,
  • pelvic floor defect,
  • previous surgery for urinary incontinence,
  • neurological diseases
  • pregnancy.

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Biyofeedback

Extracorporeal Magnetic Innervation

Arm Description

the patients underwent 16 sessions of biofeedback-assisted pelvic floor muscle training over 8 weeks for 20 minutes

the patients underwent 16 sessions of biofeedback-assisted pelvic floor muscle training over 8 weeks for 20 minutes and the Extracorporeal Magnetic Innervation application was made for 20 minutes

Outcomes

Primary Outcome Measures

Pelvic Floor Muscle Strength with Perineometer
Perineometer: It is a vaginal dynamometer used for objective evaluation of pelvic floor muscle strength during its contractions. The intravaginal pressure unit is, cmH2O İn. The pelvic floor muscle strength is evaluated by placing the vaginal probe 3 cm deep inside vagina. The nominal measurement range is 30-60 cmH2O. Pressure may decrease to 0-5 cmH2O in patients with weak pelvic floor muscles
Pelvic Floor Muscle Strength with Modified Oxford Scale
Modified Oxford Scale: Grade 0: No contraction. Grade 1: Contraction is minimal. The patient can hold the fingers under 1 second. Grade 2: Contraction is poor. There is no elevation in the fingers. The patient can hold the fingers for 1-3 seconds. Grade 3: The fingers of the therapist are elevated to the posterior vaginal wall with contraction. There is a minimal pressure and the patient can hold the fingers for 4-6 seconds. Grade 4: The fingers of the therapist are elevated to the posterior vaginal wall. There is a sense of intensive pressure on the fingers. The patient can hold the fingers for 7-9 seconds. Grade 5: A strong contraction lasting for 9 seconds and a great resistance against the fingers of the therapist.
Incontinence Quality of Life
The quality of life of the patients was measured by the Incontinence Quality of Life Questionnaire IQOL consists of 22 questions and three subscales: behavior limitations (1st, 2nd, 3rd, 4th, 10th, 11th, 13th, 20th items), the psychosocial influence (5th, 6th, 7th, 9th, 15th, 16th, 17th, 21st, 22nd items) and the social isolation (8th, 12th, 14th, 18th, 19th items). All items in I-QOL are evaluated with a five-category Likert-type scale: 1= very much, 2= quite, 3= moderate, 4= somewhat, 5= not at all. The calculated total score is converted to a value between 0 to 100 to interpret the results easily. The increased score obtained from the scale indicates an increase in quality of life.
Sexual Function
Female Sexual Function Index consists of 19 items and 6 subscales developed by Rosen et al. in 2000 to assess female sexual function in the USA. In this scale, sexual problems or functions in the last four weeks are assessed. Of the items in the scale, 3-14 and 15-19 are rated on a 6-point Likert scale ranging between 0 and 5, and the rest are rated on a 5-point Likert scale ranging between 1 and 5. The scoring of the scale items is different. While the items 1, 2, 15 and 16 are rated as 5-4-3-2-1, the other items are scored as 0-1-2-3-4-5. The total score for the overall scale is calculated by multiplying the scores obtained from the subscales by the factor loads. The lowest and highest achievable scores from the scale are 2.0 and 36.0 respectively.
The amount of leakage
Pad Test: In the study, a one-hour pad test standardized by the International Continence Society was applied to the patients and it was evaluated as the following: <2 gr- Dry 2-10 gr- Mild/Moderate Urinary Incontinence 10-50 gr- Severe Urinary Incontinence > 50 gr- Very Severe Urinary Incontinence

Secondary Outcome Measures

Full Information

First Posted
March 11, 2019
Last Updated
March 13, 2019
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT03875196
Brief Title
The Effect Of Pelvic Floor Muscle Training With Biofeedback And Extracorporeal Magnetic Innervation On The Urinary Symptoms, Sexual Function And Quality Of Life
Official Title
The Effect Of Pelvic Floor Muscle Training With Bıofeedback And Extracorporeal Magnetic Innervation On The Urinary Symptoms, Sexual Function And Quality Of Life Of Women With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
September 1, 2015 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege 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
The effect of Pelvic Floor Muscle Training with Biofeedback and Extracorporeal Magnetic Innervation on the Urinary Symptoms, Sexual Function and Quality of Life of Women with Stress Urinary Incontinence
Detailed Description
Introduction and hypothesis: This research was made in order to analyze the impact of the with with Electromyelographic-Biyofeedback added Extracorporeal Magnetic Innervation technique performed on the urinary symptoms, quality of life and sexual function of women with stress urinary incontinence. Methods: The research type is a pre-test and post-test randomized controlled with experimental nature. The research sample consists of 26 patients in the Biyofeedback group and 25 patients in the with Electromyelographic-Biyofeedback added Extracorporeal Magnetic Innervation group who were examined in the urogynecology policlinics and diagnosed with stress urinary incontinence. between September 2015 and September 2016. At the first meeting, the case report form is filled and the following list is applied for each patience: incontinence life quality scale, female sexual function scale, Q-type test, residue urine volume, one-hour pad test, perineometer, muscle force measurement with Modified Oxford Scale and a three-day bladder diary. Moreover, the Electromyelographic-Biyofeedback was applied to the first group in the clinic for 20 minutes two days a week for eight weeks. The Electromyelographic-Biyofeedback following with 20 minutes Extracorporeal Magnetic Innervation was applied to the second group in the clinic for 20 minutes two days a week for eight weeks. The list applied at the first meeting were repeated after eight weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Stress urinary incontinence, quality of life, sexual function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The sample of the research is comprised of patients diagnosed with stress urinary incontinence and volunteered for participating in the study with the following specifications: with pelvic floor power 2 and over, sexually active and no restrictions for the magnetic chair treatment. Patients with the following conditions were excluded: prosthesis, other implanted metallic devices, cardiac pacemaker, arrhythmia, pelvic malignancies, under radiotherapy, pelvic floor defect, previous surgery for urinary incontinence, neurological diseases and pregnancy.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biyofeedback
Arm Type
Experimental
Arm Description
the patients underwent 16 sessions of biofeedback-assisted pelvic floor muscle training over 8 weeks for 20 minutes
Arm Title
Extracorporeal Magnetic Innervation
Arm Type
Experimental
Arm Description
the patients underwent 16 sessions of biofeedback-assisted pelvic floor muscle training over 8 weeks for 20 minutes and the Extracorporeal Magnetic Innervation application was made for 20 minutes
Intervention Type
Device
Intervention Name(s)
Pelvic Floor Muscle Training With Biofeedback
Intervention Description
Biyofeedback: The Biyofeedback allows the patient to see the results of her behavior immediately By a perineometer device or electromyelography that is placed in the vagina, the patient sees how she hears the pelvic floor muscles, hears the sound or hears her voice, and detects how much she needs to contract.
Intervention Type
Device
Intervention Name(s)
Extracorporeal Magnetic Innervation
Intervention Description
Extracorporeal Magnetic Innervation: The patients are seated in a special chair connected to an external power unit and a magnetic field generator inside with their clothes on. In order to coincide the spreading magnetic field with pelvic floor muscles, the urethral and anal sphincters, the perineum of the patients should be placed in the center of the chair. In this way, the perineum tissues are stimulated by emitted magnetic field waves. Thus no electrical current passes through the device to the patient's body and the patient is exposed to only the magnetic current.
Primary Outcome Measure Information:
Title
Pelvic Floor Muscle Strength with Perineometer
Description
Perineometer: It is a vaginal dynamometer used for objective evaluation of pelvic floor muscle strength during its contractions. The intravaginal pressure unit is, cmH2O İn. The pelvic floor muscle strength is evaluated by placing the vaginal probe 3 cm deep inside vagina. The nominal measurement range is 30-60 cmH2O. Pressure may decrease to 0-5 cmH2O in patients with weak pelvic floor muscles
Time Frame
In the first encounter and After eight weeks
Title
Pelvic Floor Muscle Strength with Modified Oxford Scale
Description
Modified Oxford Scale: Grade 0: No contraction. Grade 1: Contraction is minimal. The patient can hold the fingers under 1 second. Grade 2: Contraction is poor. There is no elevation in the fingers. The patient can hold the fingers for 1-3 seconds. Grade 3: The fingers of the therapist are elevated to the posterior vaginal wall with contraction. There is a minimal pressure and the patient can hold the fingers for 4-6 seconds. Grade 4: The fingers of the therapist are elevated to the posterior vaginal wall. There is a sense of intensive pressure on the fingers. The patient can hold the fingers for 7-9 seconds. Grade 5: A strong contraction lasting for 9 seconds and a great resistance against the fingers of the therapist.
Time Frame
In the first encounter and After eight weeks
Title
Incontinence Quality of Life
Description
The quality of life of the patients was measured by the Incontinence Quality of Life Questionnaire IQOL consists of 22 questions and three subscales: behavior limitations (1st, 2nd, 3rd, 4th, 10th, 11th, 13th, 20th items), the psychosocial influence (5th, 6th, 7th, 9th, 15th, 16th, 17th, 21st, 22nd items) and the social isolation (8th, 12th, 14th, 18th, 19th items). All items in I-QOL are evaluated with a five-category Likert-type scale: 1= very much, 2= quite, 3= moderate, 4= somewhat, 5= not at all. The calculated total score is converted to a value between 0 to 100 to interpret the results easily. The increased score obtained from the scale indicates an increase in quality of life.
Time Frame
In the first encounter and After eight weeks
Title
Sexual Function
Description
Female Sexual Function Index consists of 19 items and 6 subscales developed by Rosen et al. in 2000 to assess female sexual function in the USA. In this scale, sexual problems or functions in the last four weeks are assessed. Of the items in the scale, 3-14 and 15-19 are rated on a 6-point Likert scale ranging between 0 and 5, and the rest are rated on a 5-point Likert scale ranging between 1 and 5. The scoring of the scale items is different. While the items 1, 2, 15 and 16 are rated as 5-4-3-2-1, the other items are scored as 0-1-2-3-4-5. The total score for the overall scale is calculated by multiplying the scores obtained from the subscales by the factor loads. The lowest and highest achievable scores from the scale are 2.0 and 36.0 respectively.
Time Frame
In the first encounter and After eight weeks
Title
The amount of leakage
Description
Pad Test: In the study, a one-hour pad test standardized by the International Continence Society was applied to the patients and it was evaluated as the following: <2 gr- Dry 2-10 gr- Mild/Moderate Urinary Incontinence 10-50 gr- Severe Urinary Incontinence > 50 gr- Very Severe Urinary Incontinence
Time Frame
In the first encounter and After eight weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria patients diagnosed with stress urinary incontinence with pelvic floor power 2 and over, sexually active and no restrictions for the magnetic chair treatment. Exclusion Criteria: patients with prosthesis, other implanted metallic devices, cardiac pacemaker, arrhythmia, pelvic malignancies, under radiotherapy, pelvic floor defect, previous surgery for urinary incontinence, neurological diseases pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
oya kavlak, proffesor
Organizational Affiliation
Ege University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ahmet özgür yeniel, assosiate prf
Organizational Affiliation
Ege University
Official's Role
Study Chair
Facility Information:
Facility Name
Ege University
City
İzmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect Of Pelvic Floor Muscle Training With Biofeedback And Extracorporeal Magnetic Innervation On The Urinary Symptoms, Sexual Function And Quality Of Life

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