A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia

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.

Inclusion Criteria: 1. age ≥20 years old, ≤80 years old, female; 2. patients with overactive bladder (OAB) symptoms for more than 8 weeks; The inclusion criteria were as follows: voiding frequency ≥8 times in 24 hours, urgency attack ≥1 time in 24 hours, nocturnal voiding ≥2 times (OABSS score ≥6 points), and nocturnal polyuria index (NPi) ≤0.33. 3. the patient's physical condition is stable and can be treated at home; 4. All participants volunteered to participate in the study and provided written informed consent before the study began. Exclusion Criteria: 1. Residual urine volume ≥100 mL; 2. difficulty walking; 3. urethral stricture; 4. bladder stones; 5. bladder cancer; 6. urinary tract infection; 7. pregnant, lactating women, women of childbearing age who plan to become pregnant during the study or who do not use safe contraception; 8. pelvic organ prolapse; 9. neuropsychiatric disorders (including cerebrovascular diseases) associated with neurogenic bladder; 10. taking medications for urinary system diseases within 2 weeks before enrollment; 11. patients with mental and cognitive impairment who are unable to cooperate with treatment; 12. other conditions considered by the investigator to be inappropriate for study participation.