About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Residual urine volume ≥100 mL;
difficulty walking;
urethral stricture;
bladder stones;
Trial design
Parallel
Treatments tested in this trial
A new wearable transcutaneous tibial nerve stimulation (TTNS) device
DeviceGroup 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
BehavioralTreatment 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.
Treatment groups
Trial outcomes
Primary outcomes
Standardized 72-hour voiding diary
Standardized 72-hour voiding diary, record the frequency of daily urination over a period of three days
Overactive Bladder Symptom Score (OABSS)
The OABSS score is mainly used for initial severity grading, with total scores ranging from 0 to 15: 0-5 as mild, 6-11 as moderate, and 12-15 as severe.
Secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
PSQI is a self-rating scale that assesses subjective sleep quality, sleep latency, sleep time, sleep efficiency, sleep disorders, sleep medication use, and daytime dysfunction. The scale is divided into two parts: 19 self-rated questions to assess sleep and 5 questions that are assessed by a bed partner (those who do not have a bed partner but have family members who know can also answer). The questions are short, easy to understand, and easy to answer. PSQI questions are scored on a scale ranging from "0 = no difficulty" to "3 = very difficult", resulting in scores that correspond to the various domains of the scale. Scores range from 0 to 21, with scores greater than 5 considered to indicate a sleep disorder
Nocturia quality of life (NQOL) score
The questionnaire included 3 dimensions and 13 items. Sleep/energy (7 items, 0-28 Scores), distress/concern component (5 questions, 0-20 points) and total quality of life score (1 question, 0-4 points). Each item was selected from "0" to "4" points using Likert5 scale, with a total score of 52 points. Items 12 and 13 are reverse scoring items, with higher scores indicating higher quality of life.
Sponsors and contacts
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