Urinary Retention
Conditions
Keywords
Medical device, Bladder emptying, Underactive bladder, Benign prostatic obstruction, Residual urine, Non-invasive
Brief summary
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.
Interventions
DEVICENon-invasive bladder emptying device
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.
Sponsors
University of Bern
Ecole Polytechnique Fédérale de Lausanne
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events of special interest (AESI) | 7 days | Number of patients with adverse events of special interest (AESI) |
| Penile pain | 7 days | Assessment of penile pain (reported as numeric pain rating scale (NPRS): 0 (no pain at all) to 10 (worst imaginable pain)) |
| Penile lesions | 7 days | Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra)) |
| Hematuria | 7 days | Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voided urine volume | 1 day | Assessment of voided urine volume, measured by uroflowmeter/scale \[ml\] |
| Residual volume | 1 day | Assessment of residual volume, measured with ultrasound bladder scanner \[ml\] |
| Voiding time | 1 day | Assessment of voiding time, measured with clock \[s\] |
| Urine flow rate | 1 day | Assessment of urine flow rate, measured with uroflowmeter \[ml/s\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability of the device | 1 day | Assessment of usability and device acceptance, measured with a patient questionnaire (multiple choice questions and likert scale) |
Countries
Switzerland
Outcome results
None listed