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

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

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 Overview

• Status: Terminated
• Conditions: Urinary Retention
• Intervention / Treatment: Device: Non-invasive bladder emptying device

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Bern University Hospital Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the device	Assessment of usability and device acceptance, measured with a patient questionnaire (multiple choice questions and likert scale)	1 day

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern; Ecole Polytechnique Fédérale de Lausanne
• Investigators: Principal Investigator: Bernhard Kiss, Department of Urology

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Non-invasive; Medical device; Benign prostatic obstruction; Residual urine; Bladder emptying; Underactive bladder
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: CIP_NIBED_V1-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No