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

Pamukkale University

Status: Not yet enrolling

Conditions: Urinary Bladder, Overactive

Treatments: Other: Sham Transcutaneous tibial nerve stimulation (TTNS); Other: Transcutaneous tibial nerve stimulation (TTNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06385769

PamukkaleU.ftr-NYıldız-3

Details and patient eligibility

About

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).

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

Transcutaneous tibial nerve stimulation (TTNS)

Experimental group

Description:

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.

Treatment:

Other: Transcutaneous tibial nerve stimulation (TTNS)

Sham Transcutaneous tibial nerve stimulation (TTNS)

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Transcutaneous tibial nerve stimulation (TTNS)