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

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Terminated

CT.gov ID

NCT04919798

Collaborator

University of Bern (Other), Ecole Polytechnique Fédérale de Lausanne (Other)

Enrollment

Location

Arms

9.1

Actual Duration (Months)

1.1

Patients Per Site Per Month

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
Urinary Retention	Device: Non-invasive bladder emptying device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 26, 2021

Actual Primary Completion Date :

Apr 28, 2022

Actual Study Completion Date :

Apr 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
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: NIBED
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: NIBED

Arm

Intervention/Treatment

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:

NIBED

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:

NIBED

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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