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

Overview

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.

In strict accordance with the inclusion criteria and exclusion criteria, appropriate research participants were screened to participate in this clinical study. At least 80 cases were completed, with 40 cases in the experimental group and 40 cases in the control group. Participants in group A were treated with A new wearable transcutaneous tibial nerve stimulation (TTNS) device combined with behavioral therapy (BT), while participants in group B were treated with behavioral therapy alone. Participants were followed up at 4, 8, and 12 weeks after enrollment. The improvement of voiding symptoms (frequent urination, urgency, urge incontinence, etc.) and sleep quality were analyzed at different stages. 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. Baseline data of all participants were collected at the time of enrollment: (1) basic information of patients, including age, gender, height, weight, history of smoking and alcohol, lower urinary tract dysfunction symptoms, previous treatment of OAB and nocturia, and medication history; (2) Pittsburgh sleep Quality index (PSQI); (3) standardized 72-hour voiding diary, sleep onset and awakening time, voiding volume and time, fluid intake and time, and incontinence time; (4) previous treatment of OAB and nocturia, and list of current drugs; (5) Overactive bladder symptom score (OABSS); (6) Nocturia quality of life (NQOL) score. Study participants were followed up or reexamined at 4, 8, and 12 weeks after enrollment. Data on: (1) Pittsburgh sleep Quality Index (PSQI); (2) Standardized 72-hour voiding diary, sleep onset and awakening time, voiding volume and time, fluid intake and time, and incontinence time; (3) list of currently used drugs; (4) Overactive bladder symptom score (OABSS); (5) Nocturia quality of life (NQOL) score; (6) Urinary tract infection and adverse events.