A Single-Center Randomized Controlled Trial Evaluating the Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation Compared to Conventional Protocol in Patients With Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Overactive Bladder Symptom Score (OABSS)
研究概览
简要总结
The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. The main questions it aims to answer are:
- Does using TENS at home during daily activities reduce the number of urgency episodes?
- Does this approach improve bladder symptoms and quality of life as much as clinic-based treatment?
Researchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation):
- Group 1 (Clinic-based): Participants will visit the clinic twice a week for 2 weeks and receive 30-minute TENS sessions.
- Group 2 (Ambulatory): Participants will use a portable TENS device at home during their daily routine when they feel the urge to urinate, over a 2 week period.
Both groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width).
Participants will:
- Complete bladder symptom questionnaires before and after the study
- Fill in a 3-day voiding diary to track how often they urinate, urgency episodes, and any leakage
- Answer quality of life questions at the start and at 4 weeks
详细描述
Overactive bladder (OAB) is a common condition that causes a sudden, strong need to urinate. It may also cause frequent urination during the day and night, and sometimes urine leakage. Transcutaneous tibial nerve stimulation (TTNS) is a safe, non-invasive treatment that uses mild electrical impulses through the skin near the ankle to calm bladder activity. The posterior tibial nerve at the ankle shares the same spinal nerve roots (L4-S3) that control the bladder.
Current TTNS protocols require regular clinic visits on a fixed schedule. This study introduces an ambulatory approach where participants use a portable TENS device in their daily life when urgency symptoms occur, rather than attending scheduled clinic sessions.
This is a prospective, single-center, randomized controlled trial conducted at Başakşehir Çam and Sakura City Hospital, Istanbul, Turkey. A total of 30 to 50 adults aged 18 to 65 with a clinical diagnosis of OAB who have not improved enough with lifestyle changes and behavioral therapy will be enrolled.
Participants will be randomly placed into one of two groups:
Group 1 - Conventional TTNS: Clinic-based sessions, twice per week for 2 weeks (4 sessions total), each lasting 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years
- •Clinical diagnosis of overactive bladder (OAB)
- •Working in an office setting or spending most of the day at home, suitable for using a portable TENS device
排除标准
- •Pregnancy
- •Cardiac pacemaker
- •Metal implant in the ankle area
- •Open wound or skin disease at the electrode site
- •Active urinary tract infection
- •Neurological disease affecting bladder function
- •Previous surgery for urinary incontinence or OAB
- •Current anticholinergic or beta-3 agonist use for OAB
- •Cognitive impairment preventing proper device use
研究组 & 干预措施
Conventional Clinic-Based TTNS
Participants will receive transcutaneous tibial nerve stimulation (TTNS) at the clinic twice per week for 2 weeks (4 sessions total). Each session will last 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters will be set at 20 Hz frequency and 200 µs pulse width, with intensity adjusted to the highest comfortable level below the motor threshold.
干预措施: Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation (Device)
Ambulatory Self-Administered TTNS
Participants will be provided with a portable TENS device and instructed to self-administer TTNS during their daily activities when they experience urgency symptoms over a 2-week period. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters will be set at 20 Hz frequency and 200 µs pulse width, with intensity adjusted to the highest comfortable level below the motor threshold. Participants will receive training on correct electrode placement and device use at the first visit.
干预措施: Ambulatory Transcutaneous Tibial Nerve Stimulation (Device)
结局指标
主要结局
Change in Overactive Bladder Symptom Score (OABSS)
时间窗: Baseline and 4 weeks
OABSS is a 4-item self-administered questionnaire measuring the frequency of daytime urination, nighttime urination, urgency, and urgency urinary incontinence. Total score ranges from 0 to 15. Higher scores indicate more severe OAB symptoms and worse outcome.
OAB-V8 (Overactive Bladder - V8 Questionnaire)
时间窗: Baseline and 4 weeks
Description: OAB-V8 is an 8-item patient-reported questionnaire assessing the bothersomeness of overactive bladder symptoms. Each item is scored from 0 (not at all) to 5 (a very great deal), yielding a total score ranging from 0 to 40. Higher scores indicate greater symptom burden and worse outcome.
Health-Related Quality of Life - International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
时间窗: Baseline and 4 weeks
The ICIQ-OAB is a patient-reported outcome measure assessing the frequency and bothersomeness of overactive bladder symptoms including daytime urinary frequency, nocturia, urgency, and urgency urinary incontinence. It consists of 4 items, each rated on a symptom frequency scale. Total score ranges from 0 to 16. Higher scores indicate more severe overactive bladder symptoms and worse outcome.
次要结局
- Patient Satisfaction - Patient Global Impression of Improvement (PGI-I)(4 weeks)
研究者
SEZGIN
M.D. Veysel Sezgin
Başakşehir Çam & Sakura City Hospital