Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke

N/ANot Yet RecruitingNCT06385769

Pamukkale University22 enrolled

Overview

The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke. The main questions aimed to be answered are: What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Urinary Bladder, Overactive

Interventions

The TTNS will be conducted unilaterally, with the patient in a supine position, using a surface electrode dual stimulation channel stimulation device. Two self-adhesive round surface electrodes will be positioned with the negative electrode 2 cm behind the medial malleolus and the positive electrode 10 cm proximal to it. The ground electrode will be placed on the ipsilateral limb. Channel 1 will provide active stimulation, while channel 2 will remain inactive.

Sham Transcutaneous tibial nerve stimulation (TTNS)OTHER

Sham TTNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the TTNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 40 and above with stable ischemic or hemorrhagic stroke. * Patients with neurogenic detrusor overactivity symptoms accompanied by urinary incontinence complaints and a urinary frequency of 9 or more. * Patients diagnosed with detrusor overactivity on urodynamic evaluation. * Patients with hemiplegia lasting between 30 days and 1 year. * Ability to understand procedures, benefits, and potential side effects. * Patients scoring 22 or above on the Mini Mental Test. Exclusion Criteria: * Patients with post-stroke neurogenic detrusor overactivity receiving or previously received pharmacological treatment. * Patients using intermittent catheterization or permanent catheterization as a bladder emptying method. * Patients with a history of urinary incontinence and/or urinary retention before stroke. * History of past urogynecological surgery. * Presence of urinary tract infection, bladder tumor, or cardiac pacemaker. * Significant fluid infusion requirement affecting urination or use of medication affecting bladder function. * Patients who have received botulinum toxin injection for post-stroke neurogenic detrusor overactivity. * Patients with postvoid residual volume above 150 mL.

Outcomes

Primary Outcomes

Decreased frequency of increased voiding

The effectiveness of the treatment is evaluated based on the daily voiding frequency post-treatment compared to the daily voiding frequency pre-treatment. The expected outcome is a reduction in the frequency of increased voiding.

Time frame: Change from baseline positive response rate at the 4th week after the treatment

Secondary Outcomes

Frequency of voiding

The frequency of voiding used will be calculated from the patient's 3-day voiding frequency.

Time frame: Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment

The Quality of Life

The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence

Time frame: Change from baseline the Quality of Life at the 4th week after the treatment

Barthel Index for Activities of Daily Living (ADL)

The Barthel Index assesses activities of daily living (ADLs), documenting what a patient does daily without determining capabilities. The 10 items to score are: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation, and stair climbing. Scores reflect independence, with lower scores indicating less independence. A score above 60 typically denotes independence.

Time frame: Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment

The Overactive Bladder Symptom Score (OABSS)

OABSS (Overactive Bladder Symptom Score), four questions assessing daytime frequency (OABSS-1), nocturia frequency (OABSS-2), urgency frequency (OABSS-3), and urgency urinary incontinence (OABSS-4). Severity is rated on a Likert scale from 0-2, 0-3, 0-5, and 0-5, respectively. The total score ranges from 0 to 15, with higher scores indicating more severe symptoms.

Time frame: Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment

Treatment Satisfaction Level

At the end of the treatment, participants will be asked to evaluate their satisfaction level with the administered treatment using a Likert scale ranging from 1 to 5 (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, 1=very dissatisfied).

Time frame: Change from baseline Treatment Satisfaction Level at the 4th week after the treatment

Cystometric value

Cystometric value are useful in defining the voiding characteristics of patients.

Time frame: Change from baseline Cystometric value at the 4th week after the treatment