The Effect of Repetative Transcranial Magnetic Stimulation Therapy on Lower Urinary System Dysfunctions in Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Change from baseline International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at 15th day and 8th week
Study Overview
Brief Summary
The aim of our study is to investigate the effect of repetitive transcranial magnetic stimulation therapy (rTMS) on lower urinary system dysfunctions and detrusor muscle activity in stroke patients.
Detailed Description
Stroke is the second leading cause of death in adults and one of the major causes of long-term disability. Functional limitations that develop in the post-stroke period affect the quality of life and activities of daily living of the patients. The main purpose of stroke rehabilitation is to improve the quality of life of patients in the areas of physical, functional, psychological and social health.
Post-stroke urinary incontinence (PSUI) is a common complication that manifests as involuntary loss of urine. It has been reported that post-stroke urinary incontinence (PSUI) affects 40-60% of patients admitted to the hospital after stroke, up to 25% still have problems when they are discharged from the hospital, and 15% remain incontinence one year later. Recent studies have shown that 79% of stroke survivors develop urinary incontinence.
It has been reported that this complication is also associated with psychological problems such as low self-esteem and anxiety. In addition, the presence of urinary incontinence has been considered a marker of stroke severity and a higher mortality rate than those without urinary incontinence. Therefore, Post-stroke urinary incontinence (PSUI) management is critical and should be the goal of all stroke health professionals.
In recent years, there is a need for more effective approaches on neuroplasticity mechanisms in stroke rehabilitation. Repetitive transcranial magnetic stimulation (rTMS) is an innovative approach applied in this field. With the application of repetitive transcranial magnetic stimulation (rTMS), it is aimed to modulate plasticity and restore the normal activity pattern.
Repetitive transcranial magnetic stimulation (rTMS) is a painless non-invasive technique widely used in clinical routine practice to modulate the neural excitability of the human brain. High frequency rTMS (>5 Hz) increases neural activity (long term potentiation), while low frequency (1 Hz) rTMS decreases neural activity (long term depression).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A person between the ages of 40-80 who applied to AFSU Physical Medicine and Rehabilitation Clinic with the diagnosis of stroke in the inpatient service or outpatient for neurological rehabilitation,
- •Having had a stroke at least three months ago,
- •Able to follow two-stage verbal commands and agree to participate in the study voluntarily and regularly,
- •Medically stable,
- •Neurologically stable,
- •After taking the anamnesis and physical examination, patients who meet the inclusion criteria and whose
Exclusion Criteria
- •were excluded will be included in the study
- •Exclusion Criteria:
- •Patients with significant comorbidities such as severe heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension,
- •Epilepsy, history of antiepileptic drug use intracranial metal body,
- •Having an ear implant,
- •Cognitive dysfunction,
- •Lower extremity peripheral nerve injury
- •Malignancy
- •Active infection
- •Infection on the skin in the application area, open wound
- •İnflammatory disease
- •Orthopedic injuries that can limit maximal effort contractions
- •Brain lesion or history of drug use that may affect seizure threshold
- •İncreased intracranial pressure
- •Patients with uncontrolled migraine
Outcomes
Primary Outcomes
Change from baseline International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at 15th day and 8th week
Time Frame: up to 8th week
Evaluates the severity of urinary incontinence symptoms and their impact on health-related quality of life. When using the ICIQ-UI SF, an overall ICIQ score in the range of 0-21 is obtained from the first three questions. A score of zero means no urine leakage and no impact on quality of life. Question 1 (Q1) measures the frequency of urinary incontinence, question 2 (Q2) evaluates the amount of leakage, and question 3 (Q3) evaluates how much urinary incontinence affects daily life.
Change from baseline Danish Scale at 15th day and 8th week
Time Frame: up to 8th week
The questionnaire consists of 12 questions about lower urinary tract symptoms (LUTS). It is a questionnaire study that questions the frequency and severity of their symptoms (symptom score) and its effect on their daily life (discomfort score) from the participants. It is one of the reliable methods that questions the frequency and severity of lower urinary tract symptoms and disturbing factors.
Secondary Outcomes
- Change from baseline Beck's Depression Inventory at 15th day and 8th week(up to 8th week)
- Change from baseline Barthel İndex at 15th day and 8th week(up to 8th week)
- Change from baseline Uroflowmetry and residual urine at 15th day and 8th week(up to 8th week)
- Change from baseline Overactive Bladder Symptom Score (OABSS) at 15th day and 8th week(up to 8th week)
- Change from baseline Urinary Incontinence Quality Of Life Scale at 15th day and 8th week(up to 8th week)
- Change from baseline Quality of Life (Short Form 36 (SF-36)) at 15th day and 8th week [(up to 8th week)
Investigators
Ayşenur Beysel
Research Assistant Doctor
Afyonkarahisar Health Sciences University