Urinary RetentionNIBED pilotNCT04919798
First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
A study testing Non-invasive bladder emptying device in people with Urinary Retention, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Non-invasive bladder emptying device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Jul 2021to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Age 18 years or older
- Sex: male
- Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)
Who cannot join
- 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+
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Urinary Retention
- Being tested
- Non-invasive bladder emptying device
- Keywords
- Medical device, Bladder emptying, Underactive bladder, Benign prostatic obstruction, Residual urine, Non-invasive
- Medical subject headings
- Urinary Retention, Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive bladder emptying deviceDevice
Also called NIBED
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.
| Study group | Role | What they receive |
|---|---|---|
| Urinating with NIBED first, without NIBED second | Experimental | Urinating with NIBED first, without NIBED second Receives: Device: Non-invasive bladder emptying device |
| Urinating without NIBED first, with NIBED second | Experimental | Urinating without NIBED first, with NIBED second Receives: Device: Non-invasive bladder emptying device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile pain
Assessment of penile pain (reported as numeric pain rating scale (NPRS): 0 (no pain at all) to 10 (worst imaginable pain))
Measured: 7 days
Penile lesions
Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra))
Measured: 7 days
Hematuria
Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible))
Measured: 7 days
Number of patients with adverse events of special interest (AESI)
Number of patients with adverse events of special interest (AESI)
Measured: 7 days
Secondary outcomes (4)
Voided urine volume
Assessment of voided urine volume, measured by uroflowmeter/scale [ml]
Measured: 1 day
Residual volume
Assessment of residual volume, measured with ultrasound bladder scanner [ml]
Measured: 1 day
Voiding time
Assessment of voiding time, measured with clock [s]
Measured: 1 day
Urine flow rate
Assessment of urine flow rate, measured with uroflowmeter [ml/s]
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start26 Jul 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Why it stopped: Costs exceeding budget
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Ecole Polytechnique Fédérale de Lausanne
- Responsible party
- Sponsor
- Investigators
- Bernhard Kiss, Principal investigator, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919798
- Sponsor's protocol ID
- CIP_NIBED_V1-8
- Acronym
- NIBED pilot
- Status last verified
- Jun 2022
- First submitted
- 27 May 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Cross-over, First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
- ClinicalTrials.gov ID
- NCT04919798
- Acronym / sponsor ID
- NIBED pilot / CIP_NIBED_V1-8
- Conditions
- Urinary Retention
- Keywords
- Medical device, Bladder emptying, Underactive bladder, Benign prostatic obstruction, Residual urine, Non-invasive
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Costs exceeding budget
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, Ecole Polytechnique Fédérale de Lausanne
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urinating with NIBED first, without NIBED second | Experimental | Device: Non-invasive bladder emptying deviceUrinating with NIBED first, without NIBED second |
| Urinating without NIBED first, with NIBED second | Experimental | Device: Non-invasive bladder emptying deviceUrinating without NIBED first, with NIBED second |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent as documented by signature
- Age 18 years or older
- Sex: male
- Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive bladder emptying deviceAlso: NIBEDThe 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. | Device | Urinating with NIBED first, without NIBED second, Urinating without NIBED first, with NIBED second |
Primary outcome
Penile pain
Time frame: 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
Time frame: 7 days
Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra))
Hematuria
Time frame: 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)
Time frame: 7 days
Number of patients with adverse events of special interest (AESI)
4 secondary outcomes
Voided urine volume
Time frame: 1 day
Residual volume
Time frame: 1 day
Voiding time
Time frame: 1 day
Urine flow rate
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Costs exceeding budget). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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Pelvic Health Electrically Evoked Recording (PEER) 2 Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Kiss principal investigator
Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive bladder emptying device in people with Urinary Retention, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Costs exceeding budget). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penile pain (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.