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

NCT03875196 | Completed

• 1 other identifier: 15-7/5
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Incontinence

Keywords

Stress urinary incontinence; quality of life; sexual function

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Biyofeedback

EXPERIMENTAL

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

Extracorporeal Magnetic Innervation

EXPERIMENTAL

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; Device: Extracorporeal Magnetic Innervation

Interventions

Pelvic Floor Muscle Training With Biofeedback DEVICE

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.

Biyofeedback; Extracorporeal Magnetic Innervation

Extracorporeal Magnetic Innervation DEVICE

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.

Extracorporeal Magnetic Innervation

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Interventions

Biofeedback, Psychology

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• oya kavlak, proffesor

  Ege University

  STUDY DIRECTOR

• ahmet özgür yeniel, assosiate prf

  Ege University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 14, 2019
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 30, 2016
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)