Randomized, Controlled, Cross-over, First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of patients with adverse events of special interest (AESI)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Urinating with NIBED first, without NIBED second
Urinating with NIBED first, without NIBED second
Intervention: Non-invasive bladder emptying device (Device)
Urinating without NIBED first, with NIBED second
Urinating without NIBED first, with NIBED second
Intervention: Non-invasive bladder emptying device (Device)
Outcomes
Primary Outcomes
Number of patients with adverse events of special interest (AESI)
Time Frame: 7 days
Number of patients with adverse events of special interest (AESI)
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))
Hematuria
Time Frame: 7 days
Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible))
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))
Secondary Outcomes
- Voided urine volume(1 day)
- Voiding time(1 day)
- Residual volume(1 day)
- Urine flow rate(1 day)