Status:
TERMINATED
First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
Ecole Polytechnique Fédérale de Lausanne
Conditions:
Urinary Retention
Eligibility:
MALE
18+ years
Phase:
NA
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 residua...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature
- Age 18 years or older
- Sex: male
- Diagnosed with underactive bladder (UAB) (confirmed with urodynamic testing)
Exclusion
- 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
Key Trial Info
Start Date :
July 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04919798
Start Date
July 26 2021
End Date
April 28 2022
Last Update
June 13 2022
Active Locations (1)
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1
Bern University Hospital Inselspital
Bern, Switzerland, 3010