First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
NCT ID: NCT04919798
Last Updated: 2022-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2021-07-26
2022-04-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Urinating with NIBED first, without NIBED second
Urinating with NIBED first, without NIBED second
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.
Urinating without NIBED first, with NIBED second
Urinating without NIBED first, with NIBED second
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Sex: male
* Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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University of Bern
OTHER
Ecole Polytechnique Fédérale de Lausanne
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Bernhard Kiss
Role: PRINCIPAL_INVESTIGATOR
Department of Urology
Locations
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Bern University Hospital Inselspital
Bern, , Switzerland
Countries
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Other Identifiers
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CIP_NIBED_V1-8
Identifier Type: -
Identifier Source: org_study_id
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