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

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.

Inclusion criteria

• age ≥20 years old, ≤80 years old, female;
• 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.
• the patient's physical condition is stable and can be treated at home;
• All participants volunteered to participate in the study and provided written informed consent before the study began.

Exclusion criteria

• Residual urine volume ≥100 mL;
• difficulty walking;
• urethral stricture;
• bladder stones;
• bladder cancer;
• urinary tract infection;
• pregnant, lactating women, women of childbearing age who plan to become pregnant during the study or who do not use safe contraception;
• pelvic organ prolapse;
• neuropsychiatric disorders (including cerebrovascular diseases) associated with neurogenic bladder;
• taking medications for urinary system diseases within 2 weeks before enrollment;
• patients with mental and cognitive impairment who are unable to cooperate with treatment;
• other conditions considered by the investigator to be inappropriate for study participation.