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A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia
Sponsor: Qilu Hospital of Shandong University
Summary
Overactive bladder (OAB) is a syndrome with urgency as the main symptom, usually accompanied by frequent urination, nocturia, and sometimes urge urinary incontinence. Globally, the prevalence of OAB in the general population has been reported to be about 20%. Nocturia was defined as the patient waking up at least once during the night to urinate. Among lower urinary tract symptoms, nocturia can significantly affect daily life and quality of life. Reported causes of nocturia include nocturnal polyuria, sleep disorders, circadian rhythm disruption (e.g., circadian rhythm sleep disorders), and reduced bladder capacity. Because overactive bladder (OAB) may be associated with reduced bladder capacity, anticholinergic agents are used as standard therapy in the management of nocturia associated with OAB. However, anticholinergic medications are associated with poor adherence, such as inadequate efficacy and adverse effects (e.g., dry mouth, constipation, and cognitive impairment). Therefore, it is imperative to find alternative therapies for anticholinergic drugs. Previous studies have shown that transcutaneous tibial nerve stimulation (TNS) can also significantly improve lower urinary tract symptoms, such as frequency, urgency, incontinence, and nocturia, and is also one of the options for the treatment of OAB. A previous study also demonstrated its improvement in sleep quality in women with nocturia. However, the efficacy of tibial nerve stimulation in the treatment of active bladder with nocturia is still a blank, and further studies are needed.
Official title: A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device Combined With Behavioral Therapy (BT) Versus Behavioral Therapy in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia: a Prospective, Randomized Controlled Study
Key Details
Gender
FEMALE
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-06-10
Completion Date
2027-06-10
Last Updated
2026-06-09
Healthy Volunteers
No
Conditions
Interventions
A new wearable transcutaneous tibial nerve stimulation (TTNS) device
Group A: participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.
behavioral therapy
Treatment assignments: Group A, participants received tibial nerve stimulation three times a week (30 minutes each time) in combination with daily behavioral therapy. Group B: The study participants received daily behavioral therapy, and the improvement of symptoms was observed in the study participants at all stages.
Locations (1)
Qilu Hospital of Shandong University
Jinan, Shandong, China