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

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Urinary Retention

Treatments: Device: Non-invasive bladder emptying device

Study type: Interventional

Funder types: Other

Identifiers

NCT04919798

CIP_NIBED_V1-8

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Urinating with NIBED first, without NIBED second

Experimental group

Description:

Urinating with NIBED first, without NIBED second

Treatment:

Device: Non-invasive bladder emptying device

Urinating without NIBED first, with NIBED second

Experimental group

Description:

Urinating without NIBED first, with NIBED second

Treatment:

Device: Non-invasive bladder emptying device