Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke (NCT06385769) | Clinical Trial Compass
UnknownNot Applicable
Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke
Turkey (Türkiye)22 participantsStarted 2024-04-22
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decreased frequency of increased voiding
Timeframe: Change from baseline positive response rate at the 4th week after the treatment