Multiple Sclerosis and Overactive Bladder Treatment
Primary Purpose
Neurogenic Bladder Dysfunction
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Transcutaneous Posterior Tibial Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Neurogenic Bladder Dysfunction focused on measuring Multiple Sclerosis, Overactive Bladder, Neurogenic Bladder, Electrical stimulation
Eligibility Criteria
Inclusion Criteria:
- 18-65 years old
- Woman
- Volunteer to participate in the study
- Neurogenic overactive bladder due to MS
- EDSS <7.0
- Not benefiting from pharmacological treatment
Exclusion Criteria:
- With urinary tract infection
- Diagnosed with diabetes mellitus
- Using diuretic medication
- Using clean intermittent catheterization
- Having a history of different urological diseases
- Those who have conditions that would be contraindicated for electrical stimulation (pacemaker, brain pacemaker, prosthesis)
Sites / Locations
- Istanbul Medipol Mega University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transcutaneous Posterior Tibial Nerve Stimulation Group
Repetitive Transcranial Magnetic Stimulation Group
Arm Description
The treatment will be carried out by the physiotherapist using the TenStem Eco Basic device.
The treatment will be applied with a Power Mag device.
Outcomes
Primary Outcome Measures
Urodynamics Test
While the bladder is being filled, it will be carried out to measure the pressures in the bladder and in the abdomen, to examine the nerves that provide bladder contractions, and to explain the cases of urinary incontinence or inability by examining the bladder contraction pressures and electrical activity during urination.
Extended Disability Status Scale (EDSS)
It is the most commonly used scale to assess disability in MS. EDSS scoring is based on the neurological examination results of eight functional systems and the patient's ambulation status. Functional systems are listed as pyramidal, cerebellar, brainstem, sensory, bladder and intestinal, visual, cerebral, and others. A score of 0-10 is given.0 denotes normal neurological examination, 10 denotes death due to MS. 1.0-4.5 refers to fully ambulatory, 5.0-9.5 refers to impaired ambulation. From 7.0 onwards there is wheelchair use and increasingly bed dependency.
Overactive Bladder Questionnaire-V8 (OAB-V8)
The severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and too many (5) it consists of 8 questions that can be graded. The total score can vary between 0 and 40.
Incontinence Quality of Life -I-QOL
It consists of a total of 22 questions with three sub-dimensions. Sub-dimensions; limitation of behaviors (1,2,3,4,10,11,13,20 items), psychosocial influence (5,6,7,9,15,16,17,21,22 items) and social isolation (8,12 ,14,18,19 items). All items are evaluated with a five-point Likert type (1= too much, 2= a quite, 3= moderately, 4= a little, 5= not at all) and the Likert types are recalculated to take a value between 0-100 points in order to better understand the total score calculated. Higher scores indicate better quality of life.
Voiding Diary
It is recommended to present the information given by the patients in an objective way. Although not entirely diagnostic, diary data can reveal normal and abnormal conditions. The 3-day voiding diary is a viable, reliable and valid tool in the evaluation of patients with lower urinary tract symptoms.
Incontinence Severity Index (ISI)
It consists of 2 questions, and the total score is obtained by multiplying the frequency of urinary incontinence and the amount of urine leaked, and the score range varies between 1-12. According to their score, 1-2 points are light; 3-6 points average; 8-9 points indicate severe and 12 points very severe urinary incontinence.
Secondary Outcome Measures
Full Information
NCT ID
NCT05312138
First Posted
December 26, 2021
Last Updated
August 15, 2022
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05312138
Brief Title
Multiple Sclerosis and Overactive Bladder Treatment
Official Title
The Effect of Different Neuromodulation Techniques in the Treatment of Multiple Sclerosis Patients With Neurogenic Bladder Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Urinary symptoms are frequently seen in patients with Multiple Sclerosis (MS). Early evaluation of the patients in terms of the urinary system, planning the appropriate treatment and following up at regular intervals are extremely important in terms of preventing urinary system complications. Neuromodulation applications are used reliably in the urological treatment of MS patients. The aim of this study was to compare the efficacy of different neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and repetitive transcranial magnetic stimulation, in patients with MS reporting lower urinary tract symptoms.
Detailed Description
Bladder dysfunction is one of the most disturbing symptoms of MS. The frequency of bladder dysfunction in patients with MS is reported to be %52-97. Urinary symptoms are among the initial symptoms in %10-15 of patients, while it is the only initial symptom in up to %2 of patients. Patients is seen with irritative symptoms (such as frequent urination, urgency, urinary incontinence, nocturia), obstructive symptoms (such as difficulty in initiating urination, inability to urinate, feeling of incomplete emptying, weak urine flow) or mixed type symptoms.In line with these symptoms, early evaluation of MS patients in terms of urinary system, planning of appropriate treatment and regular follow-up are extremely important in terms of preventing urinary system complications. Pharmacotherapy and clean intermittent catheterization are the first step treatments for lower urinary tract symptoms in multiple sclerosis. It has been reported in the literature that electrical nerve stimulation therapy (neuromodulation methods) and behavior change methods (pelvic floor muscle exercise, bladder training, urinary diary keeping) are also used as a second step treatment option due to the side effects of anticholinergic use and lack of motivation and skill in catheterization. It is reported that neuromodulation applications are performed in MS patients and it is a reliable method. Deep brain stimulation, transcranial magnetic stimulation, posterior tibial nerve stimulation, sacral neuromodulation and spinal cord stimulation are generally recommended in the treatment of bladder dysfunction, which is one of the neuromodulation methods. The superiority of these methods to each other is debatable. In line with this information, the aim of the study is to compare the effectiveness of different neuromodulation techniques, transcutaneous posterior tibial nerve stimulation and repetitive transcranial magnetic stimulation, in MS patients reporting lower urinary tract symptoms.
According to the treatment protocols of the patients to be included in the study; will be divided into 2 groups as transcutaneous posterior tibial nerve stimulation group (8 patients) and repetitive transcranial magnetic stimulation group (8 patients). Which method will be applied to which individual will be determined randomly. Treatment sessions will be carried out for 5 consecutive days in 2 consecutive weeks, 1 time per day for a total of 10 sessions. The urological parameters of the patients in all groups will be evaluated before and after the treatment.
Statistical method(s); Statistical analysis of the data obtained from the study will be done in the Statistical Package for the Social Sciences (SPSS) 22.0 package program. The mean standard deviation, median, minimum and maximum values will be used to define the data. Comparison of continuous variables between groups will be done with Mann Whitney U test, comparison of discrete variables will be done with chi-square test. Spearman or Pearson correlation test will be used to evaluate the correlation between variables. In the data analysis, p < 0.05 level will be considered statistically significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder Dysfunction
Keywords
Multiple Sclerosis, Overactive Bladder, Neurogenic Bladder, Electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous Posterior Tibial Nerve Stimulation Group
Arm Type
Experimental
Arm Description
The treatment will be carried out by the physiotherapist using the TenStem Eco Basic device.
Arm Title
Repetitive Transcranial Magnetic Stimulation Group
Arm Type
Active Comparator
Arm Description
The treatment will be applied with a Power Mag device.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
The treatment will be internally cooled 70 mm double coil and 110 mm round coil, accompanied by a physiotherapist and neurologist. The coil will be placed on the precentral gyrus. Practices will be held, with each session lasting 20 minutes. Cortical excitability will be provided by high frequency (HF) stimulation (5-Hz).
Intervention Type
Device
Intervention Name(s)
Transcutaneous Posterior Tibial Nerve Stimulation
Intervention Description
The treatment parameters will be applied with a pulse current time of 200 μsec, a fixed frequency of 10 Hz, a treatment time of 20 minutes, and a current intensity that the patient can tolerate, which will not cause flexion in the big toe or fan movement in the other fingers. Self-adhesive surface electrodes will be used for stimulation. During the treatment, the patient will lie on his back. The negative electrode will be placed 2 cm posterior to the medial malleolus and the positive electrode will be placed 10 cm proximal.
Primary Outcome Measure Information:
Title
Urodynamics Test
Description
While the bladder is being filled, it will be carried out to measure the pressures in the bladder and in the abdomen, to examine the nerves that provide bladder contractions, and to explain the cases of urinary incontinence or inability by examining the bladder contraction pressures and electrical activity during urination.
Time Frame
"10 days" the amount of change after 10 days from the baseline
Title
Extended Disability Status Scale (EDSS)
Description
It is the most commonly used scale to assess disability in MS. EDSS scoring is based on the neurological examination results of eight functional systems and the patient's ambulation status. Functional systems are listed as pyramidal, cerebellar, brainstem, sensory, bladder and intestinal, visual, cerebral, and others. A score of 0-10 is given.0 denotes normal neurological examination, 10 denotes death due to MS. 1.0-4.5 refers to fully ambulatory, 5.0-9.5 refers to impaired ambulation. From 7.0 onwards there is wheelchair use and increasingly bed dependency.
Time Frame
"10 days" the amount of change after 10 days from the baseline
Title
Overactive Bladder Questionnaire-V8 (OAB-V8)
Description
The severity of the patients' complaints, none (0); very few (1); a little (2); quite a few (3); many (4); and too many (5) it consists of 8 questions that can be graded. The total score can vary between 0 and 40.
Time Frame
"10 days" the amount of change after 10 days from the baseline
Title
Incontinence Quality of Life -I-QOL
Description
It consists of a total of 22 questions with three sub-dimensions. Sub-dimensions; limitation of behaviors (1,2,3,4,10,11,13,20 items), psychosocial influence (5,6,7,9,15,16,17,21,22 items) and social isolation (8,12 ,14,18,19 items). All items are evaluated with a five-point Likert type (1= too much, 2= a quite, 3= moderately, 4= a little, 5= not at all) and the Likert types are recalculated to take a value between 0-100 points in order to better understand the total score calculated. Higher scores indicate better quality of life.
Time Frame
"10 days" the amount of change after 10 days from the baseline
Title
Voiding Diary
Description
It is recommended to present the information given by the patients in an objective way. Although not entirely diagnostic, diary data can reveal normal and abnormal conditions. The 3-day voiding diary is a viable, reliable and valid tool in the evaluation of patients with lower urinary tract symptoms.
Time Frame
"10 days" the amount of change after 10 days from the baseline
Title
Incontinence Severity Index (ISI)
Description
It consists of 2 questions, and the total score is obtained by multiplying the frequency of urinary incontinence and the amount of urine leaked, and the score range varies between 1-12. According to their score, 1-2 points are light; 3-6 points average; 8-9 points indicate severe and 12 points very severe urinary incontinence.
Time Frame
"10 days" the amount of change after 10 days from the baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 years old
Woman
Volunteer to participate in the study
Neurogenic overactive bladder due to MS
EDSS <7.0
Not benefiting from pharmacological treatment
Exclusion Criteria:
With urinary tract infection
Diagnosed with diabetes mellitus
Using diuretic medication
Using clean intermittent catheterization
Having a history of different urological diseases
Those who have conditions that would be contraindicated for electrical stimulation (pacemaker, brain pacemaker, prosthesis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar Atak Çakır
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol Mega University Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No Plan Description
Citations:
PubMed Identifier
31541980
Citation
Nardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.
Results Reference
background
PubMed Identifier
21305588
Citation
de Seze M, Raibaut P, Gallien P, Even-Schneider A, Denys P, Bonniaud V, Game X, Amarenco G. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn. 2011 Mar;30(3):306-11. doi: 10.1002/nau.20958. Epub 2011 Feb 8.
Results Reference
background
PubMed Identifier
29115915
Citation
Abboud H, Hill E, Siddiqui J, Serra A, Walter B. Neuromodulation in multiple sclerosis. Mult Scler. 2017 Nov;23(13):1663-1676. doi: 10.1177/1352458517736150.
Results Reference
background
PubMed Identifier
10763312
Citation
Fingerman JS, Finkelstein LH. The overactive bladder in multiple sclerosis. J Am Osteopath Assoc. 2000 Mar;100(3 Suppl):S9-12.
Results Reference
background
PubMed Identifier
36388236
Citation
Atak Cakir P, Mutluay F, Hanoglu L, Guzelburc V. Effect of transcutaneous posterior tibial nerve stimulation and repetitive transcranial magnetic stimulation on neurogenic overactive bladder symptoms in female patients with multiple sclerosis: The study protocol of a randomized controlled study. Front Neurol. 2022 Oct 28;13:1011502. doi: 10.3389/fneur.2022.1011502. eCollection 2022.
Results Reference
derived
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Multiple Sclerosis and Overactive Bladder Treatment
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