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

NCT ID: NCT03875196

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2016-09-30

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Biyofeedback

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

Group Type: EXPERIMENTAL

Pelvic Floor Muscle Training With Biofeedback

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Pelvic Floor Muscle Training With Biofeedback

Intervention Type: 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.

Extracorporeal Magnetic Innervation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

sureyya gumussoy

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

oya kavlak, proffesor

Role: STUDY_DIRECTOR

Ege University

ahmet özgür yeniel, assosiate prf

Role: STUDY_CHAIR

Ege University

Locations

Ege University

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

15-7/5

Identifier Type: -

Identifier Source: org_study_id