Clinical trial NCT03875196: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Stress urinary incontinence
quality of life
sexual function
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 51
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pelvic Floor Muscle Strength with Perineometer
timeFrame: In the first encounter and After eight weeks
measure: Pelvic Floor Muscle Strength with Modified Oxford Scale
timeFrame: In the first encounter and After eight weeks
measure: Incontinence Quality of Life
timeFrame: In the first encounter and After eight weeks
measure: Sexual Function
timeFrame: In the first encounter and After eight weeks
measure: The amount of leakage
timeFrame: In the first encounter and After eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Bornova
Study officials:
affiliation: Ege University
name: oya kavlak, proffesor
role: STUDY_DIRECTOR
affiliation: Ege University
name: ahmet özgür yeniel, assosiate prf
role: STUDY_CHAIR
References: