First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled, Cross-over, First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study

Conditions
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Urinary Retention

Intervention / Treatment
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* Device: Non-invasive bladder emptying device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urinating with NIBED first, without NIBED second<br>Urinating with NIBED first, without NIBED second | Device: Non-invasive bladder emptying device<br>* 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.<br>* Other names: NIBED;|
| Experimental: Urinating without NIBED first, with NIBED second<br>Urinating without NIBED first, with NIBED second | Device: Non-invasive bladder emptying device<br>* 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.<br>* Other names: NIBED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile pain | Assessment of penile pain (reported as numeric pain rating scale (NPRS): 0 (no pain at all) to 10 (worst imaginable pain)) | 7 days | 
| Penile lesions | Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra)) | 7 days | 
| Hematuria | Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible)) | 7 days | 
| Number of patients with adverse events of special interest (AESI) | Number of patients with adverse events of special interest (AESI) | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voided urine volume | Assessment of voided urine volume, measured by uroflowmeter/scale [ml] | 1 day | 
| Residual volume | Assessment of residual volume, measured with ultrasound bladder scanner [ml] | 1 day | 
| Voiding time | Assessment of voiding time, measured with clock [s] | 1 day | 
| Urine flow rate | Assessment of urine flow rate, measured with uroflowmeter [ml/s] | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical device, Bladder emptying, Underactive bladder, Benign prostatic obstruction, Residual urine, Non-invasive