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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-80
SponsorQilu Hospital of Shandong University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • A new wearable transcutaneous tibial nerve stimulation (TTNS) device

    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

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TTNS+BT (A)Experimental treatment 2 interventions
Group B: BT (B)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Standardized 72-hour voiding diary

Standardized 72-hour voiding diary, record the frequency of daily urination over a period of three days

Time frame
From enrollment to the end of treatment at 12 weeks
2

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.

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

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

Time frame
From enrollment to the end of treatment at 12 weeks
2

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.

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

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