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

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

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

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Pelvic Floor Muscle Training With Biofeedback; Device: Extracorporeal Magnetic Innervation

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35100
      • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Biyofeedback; the patients underwent 16 sessions of biofeedback-assisted pelvic floor muscle training over 8 weeks for 20 minutes	Device: Pelvic Floor Muscle Training With Biofeedback; 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.
EXPERIMENTAL: Extracorporeal Magnetic Innervation; 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	Device: Pelvic Floor Muscle Training With Biofeedback; 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.; Device: Extracorporeal Magnetic Innervation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	In the first encounter and After eight weeks
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.	In the first encounter and After eight weeks
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.	In the first encounter and After eight weeks
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.	In the first encounter and After eight weeks
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	In the first encounter and After eight weeks

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Study Director: oya kavlak, proffesor, Ege University; Study Chair: ahmet özgür yeniel, assosiate prf, Ege University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 30, 2016

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (ACTUAL): March 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; Stress urinary incontinence; sexual function
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 15-7/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No