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

Primary Purpose

Urinary Retention

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Non-invasive bladder emptying device
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention focused on measuring Medical device, Bladder emptying, Underactive bladder, Benign prostatic obstruction, Residual urine, Non-invasive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Bern University Hospital Inselspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Urinating with NIBED first, without NIBED second

Urinating without NIBED first, with NIBED second

Arm Description

Urinating with NIBED first, without NIBED second

Urinating without NIBED first, with NIBED second

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Voided urine volume
Assessment of voided urine volume, measured by uroflowmeter/scale [ml]
Residual volume
Assessment of residual volume, measured with ultrasound bladder scanner [ml]
Voiding time
Assessment of voiding time, measured with clock [s]
Urine flow rate
Assessment of urine flow rate, measured with uroflowmeter [ml/s]

Full Information

First Posted
May 27, 2021
Last Updated
June 9, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern, Ecole Polytechnique Fédérale de Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT04919798
Brief Title
First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
Acronym
NIBED pilot
Official Title
Randomized, Controlled, Cross-over, First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Costs exceeding budget
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern, Ecole Polytechnique Fédérale de Lausanne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
Medical device, Bladder emptying, Underactive bladder, Benign prostatic obstruction, Residual urine, Non-invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urinating with NIBED first, without NIBED second
Arm Type
Experimental
Arm Description
Urinating with NIBED first, without NIBED second
Arm Title
Urinating without NIBED first, with NIBED second
Arm Type
Experimental
Arm Description
Urinating without NIBED first, with NIBED second
Intervention Type
Device
Intervention Name(s)
Non-invasive bladder emptying device
Other Intervention Name(s)
NIBED
Intervention Description
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.
Primary Outcome Measure Information:
Title
Penile pain
Description
Assessment of penile pain (reported as numeric pain rating scale (NPRS): 0 (no pain at all) to 10 (worst imaginable pain))
Time Frame
7 days
Title
Penile lesions
Description
Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra))
Time Frame
7 days
Title
Hematuria
Description
Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible))
Time Frame
7 days
Title
Number of patients with adverse events of special interest (AESI)
Description
Number of patients with adverse events of special interest (AESI)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Voided urine volume
Description
Assessment of voided urine volume, measured by uroflowmeter/scale [ml]
Time Frame
1 day
Title
Residual volume
Description
Assessment of residual volume, measured with ultrasound bladder scanner [ml]
Time Frame
1 day
Title
Voiding time
Description
Assessment of voiding time, measured with clock [s]
Time Frame
1 day
Title
Urine flow rate
Description
Assessment of urine flow rate, measured with uroflowmeter [ml/s]
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
Usability of the device
Description
Assessment of usability and device acceptance, measured with a patient questionnaire (multiple choice questions and likert scale)
Time Frame
1 day

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Kiss
Organizational Affiliation
Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bern University Hospital Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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