Multiple Sclerosis and Overactive Bladder Treatment

M

Medipol Health Group

Status

Invitation-only

Conditions

Neurogenic Bladder Dysfunction

Treatments

Device: Transcutaneous Posterior Tibial Nerve Stimulation
Device: Repetitive Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05312138
patak

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

16 participants in 2 patient groups

Transcutaneous Posterior Tibial Nerve Stimulation Group
Experimental group
Description:
The treatment will be carried out by the physiotherapist using the TenStem Eco Basic device.
Treatment:
Device: Transcutaneous Posterior Tibial Nerve Stimulation
Repetitive Transcranial Magnetic Stimulation Group
Active Comparator group
Description:
The treatment will be applied with a Power Mag device.
Treatment:
Device: Repetitive Transcranial Magnetic Stimulation

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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