First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study (NIBED pilot)
Randomized, Controlled, Cross-over, First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
The non-invasive bladder emptying device (NIBED) is a handheld medical device that is applied to the penis during urinating to aid bladder emptying in urinary retention patients with increased residual urine volume.
This pilot study primarily seeks to determine the safety of the NIBED. Secondary objectives are to assess the efficacy of the NIBED, which is defined as the ability of the medical device to aid or improve bladder emptying, i.e. leads to less residual urine compared to not using the NIBED.
During the intervention, the study participant will urinate with and without the NIBED. Safety variables such as penile pain, penile lesions and hematuria will be recorded. Efficacy will be assessed by measuring voided volume, residual volume, voiding time and urine flow rate.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Bern、スイス、3010
- Bern University Hospital Inselspital
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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:
- Informed Consent as documented by signature
- Age 18 years or older
- Sex: male
- Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)
Exclusion Criteria:
- Acute urinary tract infection
- Patients on anti-coagulants (exception Aspirin)
- Penile pain (NPRS score >2)
- Pain during voiding (NPRS >2)
- Penile lesions (NRS score >2)
- Hematuria >2+
- Mechanical subvesical obstruction (confirmed by cystoscopy) (exception BPO)
- Transurethral resection of the prostate (TURP) less than three months before visit 2
- Penile abnormalities (Buried penis, Peyronie's disease, skin lesions)
- Asensitive bladder (no sensation of bladder fullness)
- Shy bladder
- Indwelling transurethral catheter
- Inability to understand and follow the study protocol
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Participation in another interventional clinical trial within 3 months prior to visit 2 or planned participation during the trial
- Lacking capacity for consent
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:クロスオーバー割り当て
- 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 |
---|---|
実験的:Urinating with NIBED first, without NIBED second
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The NIBED is applied to the penis during urination to support bladder emptying in urinary retention patients.
It is a battery-driven handheld device that is operated by the patient himself.
他の名前:
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実験的:Urinating without NIBED first, with NIBED second
|
The NIBED is applied to the penis during urination to support bladder emptying in urinary retention patients.
It is a battery-driven handheld device that is operated by the patient himself.
他の名前:
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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 |
---|---|---|
Penile pain
時間枠:7 days
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Assessment of penile pain (reported as numeric pain rating scale (NPRS): 0 (no pain at all) to 10 (worst imaginable pain))
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7 days
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Penile lesions
時間枠:7 days
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Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra))
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7 days
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Hematuria
時間枠:7 days
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Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible))
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7 days
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Number of patients with adverse events of special interest (AESI)
時間枠:7 days
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Number of patients with adverse events of special interest (AESI)
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7 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Voided urine volume
時間枠:1 day
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Assessment of voided urine volume, measured by uroflowmeter/scale [ml]
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1 day
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Residual volume
時間枠:1 day
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Assessment of residual volume, measured with ultrasound bladder scanner [ml]
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1 day
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Voiding time
時間枠:1 day
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Assessment of voiding time, measured with clock [s]
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1 day
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Urine flow rate
時間枠:1 day
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Assessment of urine flow rate, measured with uroflowmeter [ml/s]
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1 day
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Usability of the device
時間枠:1 day
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Assessment of usability and device acceptance, measured with a patient questionnaire (multiple choice questions and likert scale)
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1 day
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協力者と研究者
捜査官
- 主任研究者:Bernhard Kiss、Department of Urology
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- CIP_NIBED_V1-8
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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