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

Urinary Retention Clinical Trial

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

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04919798
Study type Interventional
Source University Hospital Inselspital, Berne
Contact
Status Terminated
Phase N/A
Start date July 26, 2021
Completion date April 28, 2022
View Details
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