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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Bern University Hospital Inselspital
Bern, Switzerland
Penile pain
Assessment of penile pain (reported as numeric pain rating scale (NPRS): 0 (no pain at all) to 10 (worst imaginable pain))
Time frame: 7 days
Penile lesions
Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra))
Time frame: 7 days
Hematuria
Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible))
Time frame: 7 days
Number of patients with adverse events of special interest (AESI)
Number of patients with adverse events of special interest (AESI)
Time frame: 7 days
Voided urine volume
Assessment of voided urine volume, measured by uroflowmeter/scale \[ml\]
Time frame: 1 day
Residual volume
Assessment of residual volume, measured with ultrasound bladder scanner \[ml\]
Time frame: 1 day
Voiding time
Assessment of voiding time, measured with clock \[s\]
Time frame: 1 day
Urine flow rate
Assessment of urine flow rate, measured with uroflowmeter \[ml/s\]
Time frame: 1 day
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