過活動膀胱に対する外来経皮的脛骨神経刺激の有効性
単一施設ランダム化比較試験：過活動膀胱患者における従来のプロトコルと比較した外来経皮的脛骨神経刺激の有効性の評価
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
調査の概要
状態
条件
詳細な説明
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.
Group 2 - Ambulatory TTNS: Participants will receive a portable TENS device and use it at home during daily activities when they experience urgency, over a 4-week follow-up period.
Both groups will use the same stimulation settings: 20 Hz frequency and 200 µs pulse width. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. The intensity will be set at a comfortable level just below the point that causes muscle movement.
Outcomes will be measured at baseline and at 4 weeks using OAB symptom scores (OAB-V8 and/or OABSS), a 3-day voiding diary (urinary frequency, urgency episodes, incontinence episodes), and quality of life questionnaires. Treatment adherence, patient satisfaction, and any side effects will also be recorded.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Veysel Sezgin Sezgin, M.D
- 電話番号：+905513895655
- メール：veyselsezgin1@gmail.com
研究場所
-
-
Istanbul
-
Istanbul、Istanbul、トルコ（Türkiye）、34200
- 募集
- Başakşehir Çam and Sakura City Hospital, Department of Urology
-
コンタクト：
- Veysel Sezgin Sezgin, M.D.
- 電話番号：90 5513895655
- メール：veyselsezgin1@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Cardiac pacemaker
- Epilepsy
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
Participants will receive TTNS at the clinic twice per week for 2 weeks (4 sessions total), each lasting 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Sessions will be administered by a trained healthcare professional. |
|
実験的：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. |
Participants will use a portable TENS device at home during 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: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Participants will receive training on correct electrode placement and device use at the first clinic visit. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Overactive Bladder Symptom Score (OABSS)
時間枠：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. |
Baseline and 4 weeks
|
|
OAB-V8 (Overactive Bladder - V8 Questionnaire)
時間枠：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. |
Baseline and 4 weeks
|
|
Health-Related Quality of Life - International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
時間枠：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. |
Baseline and 4 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Satisfaction - Patient Global Impression of Improvement (PGI-I)
時間枠：4 weeks
|
Description: The PGI-I is a single-item patient-reported outcome measure assessing the patient's perception of overall improvement following treatment. The scale ranges from 1 to 7, where 1 = "very much better" and 7 = "very much worse." Lower scores indicate greater patient satisfaction and better outcome. The PGI-I is widely used in urological and overactive bladder clinical trials to assess treatment satisfaction. |
4 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KAEK-11/05.11.2025.397
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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