An interventional study of Transcutaneous tibial nerve stimulation (TTNS) and Sham Transcutaneous tibial nerve stimulation (TTNS) in Urinary Bladder, Overactive, sponsored by Pamukkale University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Pamukkale University · Not applicable, Interventional, and Other
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).
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's planned enrollment of 22 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
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.
Other: 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.
Other: Sham Transcutaneous tibial nerve stimulation (TTNS)
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 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.
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
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
Plan to share: No
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Pamukkale University