NCT04919798

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 26, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

May 27, 2021

Last Update Submit

June 9, 2022

Conditions

Urinary Retention

Keywords

Medical deviceBladder emptyingUnderactive bladderBenign prostatic obstructionResidual urineNon-invasive

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Voided urine volume

    1 day

  • Residual volume

    1 day

  • Voiding time

    1 day

  • Urine flow rate

    1 day

Other Outcomes (1)

  • Usability of the device

    1 day

Study Arms (2)

Urinating with NIBED first, without NIBED second

EXPERIMENTAL

Urinating with NIBED first, without NIBED second

Device: Non-invasive bladder emptying device

Urinating without NIBED first, with NIBED second

EXPERIMENTAL

Urinating without NIBED first, with NIBED second

Device: Non-invasive bladder emptying device

Interventions

Non-invasive bladder emptying deviceDEVICE

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.

Also known as: NIBED
Urinating with NIBED first, without NIBED secondUrinating without NIBED first, with NIBED second

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent as documented by signature
  • Age 18 years or older
  • Sex: male
  • Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University Hospital Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Urinary RetentionUrinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bernhard Kiss

    Department of Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 9, 2021

Study Start

July 26, 2021

Primary Completion

April 28, 2022

Study Completion

April 28, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)