Clinical trial NCT05312138: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Bladder Dysfunction
Keywords: Multiple Sclerosis
Overactive Bladder
Neurogenic Bladder
Electrical stimulation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Urodynamics Test
timeFrame: "10 days" the amount of change after 10 days from the baseline
measure: Extended Disability Status Scale (EDSS)
timeFrame: "10 days" the amount of change after 10 days from the baseline
measure: Overactive Bladder Questionnaire-V8 (OAB-V8)
timeFrame: "10 days" the amount of change after 10 days from the baseline
measure: Incontinence Quality of Life -I-QOL
timeFrame: "10 days" the amount of change after 10 days from the baseline
measure: Voiding Diary
timeFrame: "10 days" the amount of change after 10 days from the baseline
measure: Incontinence Severity Index (ISI)
timeFrame: "10 days" the amount of change after 10 days from the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol Mega University Hospital
Study officials:
name: Pınar Atak Çakır
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Fingerman JS, Finkelstein LH. The overactive bladder in multiple sclerosis. J Am Osteopath Assoc. 2000 Mar;100(3 Suppl):S9-12.
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.