NIBED pilot: First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Urinating with NIBED first, without NIBED second Urinating with NIBED first, without NIBED second |
Device: Non-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.
Other Names:
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Experimental: Urinating without NIBED first, with NIBED second Urinating without NIBED first, with NIBED second |
Device: Non-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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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))
- Number of patients with adverse events of special interest (AESI) [7 days]
Number of patients with adverse events of special interest (AESI)
Secondary Outcome Measures
- 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 Outcome Measures
- Usability of the device [1 day]
Assessment of usability and device acceptance, measured with a patient questionnaire (multiple choice questions and likert scale)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed Consent as documented by signature
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Age 18 years or older
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Sex: male
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Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)
Exclusion Criteria:
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Acute urinary tract infection
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Patients on anti-coagulants (exception Aspirin)
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Penile pain (NPRS score >2)
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Pain during voiding (NPRS >2)
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Penile lesions (NRS score >2)
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Hematuria >2+
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Mechanical subvesical obstruction (confirmed by cystoscopy) (exception BPO)
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Transurethral resection of the prostate (TURP) less than three months before visit 2
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Penile abnormalities (Buried penis, Peyronie's disease, skin lesions)
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Asensitive bladder (no sensation of bladder fullness)
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Shy bladder
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Indwelling transurethral catheter
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Inability to understand and follow the study protocol
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Previous enrolment into the current study
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Enrolment of the investigator, his/her family members, employees and other dependent persons
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Participation in another interventional clinical trial within 3 months prior to visit 2 or planned participation during the trial
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Lacking capacity for consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Bern University Hospital Inselspital | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
- University of Bern
- Ecole Polytechnique Fédérale de Lausanne
Investigators
- Principal Investigator: Bernhard Kiss, Department of Urology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP_NIBED_V1-8