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

Urinary Retention Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04919798
• Other study ID #: CIP_NIBED_V1-8
• Status: Terminated
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: June 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Switzerland	Bern University Hospital Inselspital	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Ecole Polytechnique Fédérale de Lausanne, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability of the device	Assessment of usability and device acceptance, measured with a patient questionnaire (multiple choice questions and likert scale)	1 day
Primary	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
Primary	Penile lesions	Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra))	7 days
Primary	Hematuria	Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible))	7 days
Primary	Number of patients with adverse events of special interest (AESI)	Number of patients with adverse events of special interest (AESI)	7 days
Secondary	Voided urine volume	Assessment of voided urine volume, measured by uroflowmeter/scale [ml]	1 day
Secondary	Residual volume	Assessment of residual volume, measured with ultrasound bladder scanner [ml]	1 day
Secondary	Voiding time	Assessment of voiding time, measured with clock [s]	1 day
Secondary	Urine flow rate	Assessment of urine flow rate, measured with uroflowmeter [ml/s]	1 day