Multiple Sclerosis and Overactive Bladder Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2022-12-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neurogenic Bladder Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transcutaneous Posterior Tibial Nerve Stimulation Group

The treatment will be carried out by the physiotherapist using the TenStem Eco Basic device.

Group Type EXPERIMENTAL

Transcutaneous Posterior Tibial Nerve Stimulation

Intervention Type DEVICE

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.

Repetitive Transcranial Magnetic Stimulation Group

The treatment will be applied with a Power Mag device.

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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).

Interventions

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Repetitive Transcranial Magnetic Stimulation

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

Transcutaneous Posterior Tibial Nerve Stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No