First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED… (NCT04919798) | Clinical Trial Compass
TerminatedNot Applicable
First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
Stopped: Costs exceeding budget
Switzerland10 participantsStarted 2021-07-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Penile pain
Timeframe: 7 days
2
Penile lesions
Timeframe: 7 days
3
Hematuria
Timeframe: 7 days
4
Number of patients with adverse events of special interest (AESI)