Clinical trial NCT04919798: First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
Official title: Randomized, Controlled, Cross-over, First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Retention
Keywords: Medical device
Bladder emptying
Underactive bladder
Benign prostatic obstruction
Residual urine
Non-invasive
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: Ecole Polytechnique Fédérale de Lausanne
First posted: 2021-06-09
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Penile pain
timeFrame: 7 days
measure: Penile lesions
timeFrame: 7 days
measure: Hematuria
timeFrame: 7 days
measure: Number of patients with adverse events of special interest (AESI)
timeFrame: 7 days
Secondary outcomes:
measure: Voided urine volume
timeFrame: 1 day
measure: Residual volume
timeFrame: 1 day
measure: Voiding time
timeFrame: 1 day
measure: Urine flow rate
timeFrame: 1 day
Other outcomes:
measure: Usability of the device
timeFrame: 1 day
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital Inselspital
Study officials:
affiliation: Department of Urology
name: Bernhard Kiss
role: PRINCIPAL_INVESTIGATOR
References: