Multiple Sclerosis Clinical Trial
Official title:
Effect of Transcutaneous Posterior Tibial Nerve Stimulation and Parasacral Transcutaneous Electrical Stimulation on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.
This study aims to evaluate the use of transcutaneous tibial nerve stimulation (TTNS) and parasacral nerve stimulation (PSS) methods in the treatment of overactive bladder (OAB) symptoms in patients with Multiple Sclerosis (MS), including urination frequency, urgency, urinary incontinence, post-void residue, maximum micturition rate. To investigate the effect on parameters such as voiding volume and quality of life and to compare the final results between groups.
Status | Not yet recruiting |
Enrollment | 42 |
Est. completion date | November 30, 2024 |
Est. primary completion date | August 20, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Having symptoms related to overactive bladder (OAB-v8 score ?8), - Over 18 years of age - No relapse for at least 1 month - All types of MS, including those with relapses - Female MS patients with an Expanded Disability Status Scale (EDSS) score below 7.0 - Agreeing to participate in the research Exclusion Criteria: - Patients with urinary tract infections - Patients diagnosed with diabetes mellitus - Patients using diuretic drugs or patients with a clean intermittent catheter - Patients with a history of different urological diseases - Patients with heart or brain pacemaker users, those with epilepsy, and patients with language and cognitive limitations - Patients who are pregnant or in the postpartum period - Lack of activity performance for 2 weeks (regardless of which group) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization | Marmara University |
Jacomo RH, Alves AT, Lucio A, Garcia PA, Lorena DCR, de Sousa JB. Transcutaneous tibial nerve stimulation versus parasacral stimulation in the treatment of overactive bladder in elderly people: a triple-blinded randomized controlled trial. Clinics (Sao Paulo). 2020 Jan 10;75:e1477. doi: 10.6061/clinics/2020/e1477. eCollection 2020. — View Citation
Marzouk MH, Darwish MH, El-Tamawy MS, Morsy S, Abbas RL, Ali AS. Posterior tibial nerve stimulation as a neuromodulation therapy in treatment of neurogenic overactive bladder in multiple sclerosis: A prospective randomized controlled study. Mult Scler Relat Disord. 2022 Dec;68:104252. doi: 10.1016/j.msard.2022.104252. Epub 2022 Oct 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uroflowmetry | It provides a valuable non-invasive assessment of voiding functions. It is the measurement of urine flow rate in ml/sec with the help of a flow meter. Since it is non-invasive among urodynamic tests, it can be used for screening purposes. Pattern and rate of flow depend on detrusor function and bladder outlet resistance. | Baseline | |
Primary | Uroflowmetry | It provides a valuable non-invasive assessment of voiding functions. It is the measurement of urine flow rate in ml/sec with the help of a flow meter. Since it is non-invasive among urodynamic tests, it can be used for screening purposes. Pattern and rate of flow depend on detrusor function and bladder outlet resistance. | After the 6-week intervention | |
Primary | Post voiding residue (PVR) | PVR will be measured using a 5-13-MHz convex ultrasound probe. | Baseline | |
Primary | Post voiding residue (PVR) | PVR will be measured using a 5-13-MHz convex ultrasound probe. | After the 6-week intervention | |
Secondary | Overactive bladder form (OAB-v8) | OAB-v8 is an eight-item screening test for overactive bladder (OAB) symptoms and has been validated in Turkish. The total score is between 0 and 40. Higher scores indicate OAB symptom burden and severity. | Baseline | |
Secondary | Three-day bladder diary (BD) | BD contains the most critical parameters for measuring the frequency and severity of LUTS according to International Continence Society (ICS) recommendations and definitions. The 3-day bladder diary measures the frequency of urination, nocturia, urgency, and urge incontinence for 3 consecutive days. The average frequency of each symptom over three days will be considered the final result. | Baseline | |
Secondary | King's Quality of Life Questionnaire (KHQ) | One of the commonly used quality of life measures for urinary dysfunction is the King's Quality of Life Questionnaire. It is one of the most valid and widely used questionnaires that targets the quality of life in patients with urinary incontinence and precisely measures the impact of urinary incontinence symptoms on the quality of life. | Baseline | |
Secondary | Incontinence Severity Index (ISI) | Developed for use in epidemiological and clinical studies to identify women suffering from urinary incontinence, ISI, used in many different urinary incontinence studies, consists of two questions and the total score obtained by multiplying the frequency of urinary incontinence and the amount of urinary incontinence varies between 1 and 12. | Baseline | |
Secondary | Neurogenic Bladder Symptom Score (NBSS) | The Neurogenic Bladder Symptom Score (NBSS) is a discriminatory tool developed for use in patients with spinal cord injuries, multiple sclerosis, and spina bifida. There are a total of 22 questions covering incontinence, storage and voiding symptoms, as well as urinary complications associated with neurogenic bladder dysfunction. | Baseline | |
Secondary | Overactive bladder form (OAB-v8) | OAB-v8 is an eight-item screening test for overactive bladder (OAB) symptoms and has been validated in Turkish. The total score is between 0 and 40. Higher scores indicate OAB symptom burden and severity. | After the 6-week intervention | |
Secondary | Three-day bladder diary (BD) | BD contains the most critical parameters for measuring the frequency and severity of LUTS according to International Continence Society (ICS) recommendations and definitions. The 3-day bladder diary measures the frequency of urination, nocturia, urgency, and urge incontinence for 3 consecutive days. The average frequency of each symptom over three days will be considered the final result. | After the 6-week intervention | |
Secondary | King's Quality of Life Questionnaire (KHQ) | One of the commonly used quality of life measures for urinary dysfunction is the King's Quality of Life Questionnaire. It is one of the most valid and widely used questionnaires that targets the quality of life in patients with urinary incontinence and precisely measures the impact of urinary incontinence symptoms on the quality of life. | After the 6-week intervention | |
Secondary | Incontinence Severity Index (ISI) | Developed for use in epidemiological and clinical studies to identify women suffering from urinary incontinence, ISI, used in many different urinary incontinence studies, consists of two questions and the total score obtained by multiplying the frequency of urinary incontinence and the amount of urinary incontinence varies between 1 and 12. | After the 6-week intervention | |
Secondary | Neurogenic Bladder Symptom Score (NBSS) | The Neurogenic Bladder Symptom Score (NBSS) is a discriminatory tool developed for use in patients with spinal cord injuries, multiple sclerosis, and spina bifida. There are a total of 22 questions covering incontinence, storage and voiding symptoms, as well as urinary complications associated with neurogenic bladder dysfunction. | After the 6-week intervention |
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