Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke
- Conditions
- Urinary Bladder, Overactive
- Interventions
- Other: Sham Transcutaneous tibial nerve stimulation (TTNS)Other: Transcutaneous tibial nerve stimulation (TTNS)
- Registration Number
- NCT06385769
- Lead Sponsor
- Pamukkale University
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 22
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Transcutaneous tibial nerve stimulation (TTNS) Sham Transcutaneous tibial nerve stimulation (TTNS) In the placebo group, the same electrotherapy device and settings as the active group will be used. One channel will not be connected to the patient but will display treatment details on the screen. The other channel will be connected but deliver no stimulation. Intensity for the inactive channel is limited to 2-3 mA. Patients will be informed that exceeding this threshold is prevented. Treatment includes 20 sessions of 30 minutes each, administered twice a week for four weeks. Transcutaneous tibial nerve stimulation (TTNS) Transcutaneous tibial nerve stimulation (TTNS) In this study, one channel of the stimulation device will provide active stimulation to the patient, while the second channel will not be connected. The patient won't know which channel is active. Both channels will use continuous mode with a pulse frequency of 20 Hz and a pulse width of 200 ms. The intensity for the active channel will be adjusted based on comfort level and observed hallux reaction. Treatment includes 20 sessions of 30 minutes each, administered five times a week for four weeks.
- Primary Outcome Measures
Name Time Method Decreased frequency of increased voiding Change from baseline positive response rate at the 4th week after the treatment 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.
- Secondary Outcome Measures
Name Time Method Frequency of voiding Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment The frequency of voiding used will be calculated from the patient's 3-day voiding frequency.
The Quality of Life Change from baseline the Quality of Life at the 4th week after the treatment The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence
Barthel Index for Activities of Daily Living (ADL) Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment 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.
The Overactive Bladder Symptom Score (OABSS) Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment 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.
Treatment Satisfaction Level Change from baseline Treatment Satisfaction Level at the 4th week after the treatment 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).
Cystometric value Change from baseline Cystometric value at the 4th week after the treatment Cystometric value are useful in defining the voiding characteristics of patients.
Trial Locations
- Locations (1)
Pamukkale University
🇹🇷Denizli, Turkey