A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia
A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device Combined With Behavioral Therapy (BT) Versus Behavioral Therapy in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia: a Prospective, Randomized Controlled Study
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yan Li, Doctor
- 电话号码：18560089113
- 邮箱：yanli@sdu.edu.cn
学习地点
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Shandong
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Jinan、Shandong、中国
- Qilu Hospital of Shandong University
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接触：
- Yan Li, Doctor
- 电话号码：18560089113
- 邮箱：yanli@sdu.edu.cn
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TTNS+BT (A)
The selected study participants were randomly divided into group A and group B with a ratio of 1:1. 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. |
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 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.
|
|
实验性的：BT (B)
The selected study participants were randomly divided into group A and group B with a ratio of 1:1. 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. |
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Standardized 72-hour voiding diary
大体时间：From enrollment to the end of treatment at 12 weeks
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Standardized 72-hour voiding diary, record the frequency of daily urination over a period of three days
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From enrollment to the end of treatment at 12 weeks
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Overactive Bladder Symptom Score (OABSS)
大体时间：From enrollment to the end of treatment at 12 weeks
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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.
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From enrollment to the end of treatment at 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI)
大体时间：From enrollment to the end of treatment at 12 weeks
|
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 |
From enrollment to the end of treatment at 12 weeks
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Nocturia quality of life (NQOL) score
大体时间：From enrollment to the end of treatment at 12 weeks
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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.
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From enrollment to the end of treatment at 12 weeks
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合作者和调查者
出版物和有用的链接
一般刊物
- Furtado-Albanezi D, Jurgensen SP, Avila MA, Correia GN, Driusso P. Effects of two nonpharmacological treatments on the sleep quality of women with nocturia: a randomized controlled clinical trial. Int Urogynecol J. 2019 Feb;30(2):279-286. doi: 10.1007/s00192-018-3584-8. Epub 2018 Mar 6.
- Liao L, Li X, Chong T, Chen Q, Xu Z, Huang B, Chen M, Li H, Wei Z, Shao Y, Lu J, Pang R, Li X, Wang Y. Efficacy and safety of tibial nerve stimulation using a wearable device for overactive bladder. BJU Int. 2024 Jun;133(6):760-769. doi: 10.1111/bju.16330. Epub 2024 Mar 11.
- van Balken MR, Vandoninck V, Gisolf KW, Vergunst H, Kiemeney LA, Debruyne FM, Bemelmans BL. Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. J Urol. 2001 Sep;166(3):914-8. doi: 10.1097/00005392-200109000-00025.
- Yokoyama O, Yamaguchi O, Kakizaki H, Itoh N, Yokota T, Okada H, Ishizuka O, Ozono S, Gotoh M, Sugiyama T, Seki N, Yoshida M, Yamada S. Efficacy of solifenacin on nocturia in Japanese patients with overactive bladder: impact on sleep evaluated by bladder diary. J Urol. 2011 Jul;186(1):170-4. doi: 10.1016/j.juro.2011.02.2700. Epub 2011 May 14.
- Weiss JP, Jumadilova Z, Johnson TM 2nd, Fitzgerald MP, Carlsson M, Martire DL, Malhotra A. Efficacy and safety of flexible dose fesoterodine in men and women with overactive bladder symptoms including nocturnal urinary urgency. J Urol. 2013 Apr;189(4):1396-401. doi: 10.1016/j.juro.2012.11.067. Epub 2012 Nov 15.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KYLL-2026-04-013-1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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