Randomized, Controlled, Cross-over, First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of patients with adverse events of special interest (AESI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Age 18 years or older
- •Sex: male
- •Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)
排除标准
- •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
结局指标
主要结局
Number of patients with adverse events of special interest (AESI)
时间窗: 7 days
Number of patients with adverse events of special interest (AESI)
Penile pain
时间窗: 7 days
Assessment of penile pain (reported as numeric pain rating scale (NPRS): 0 (no pain at all) to 10 (worst imaginable pain))
Hematuria
时间窗: 7 days
Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible))
Penile lesions
时间窗: 7 days
Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra))
次要结局
- Voided urine volume(1 day)
- Voiding time(1 day)
- Residual volume(1 day)
- Urine flow rate(1 day)