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 range18 Years

SexMALE

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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

What they're measuring

Penile pain

Timeframe: 7 days

Penile lesions

Timeframe: 7 days

Hematuria

Timeframe: 7 days

Number of patients with adverse events of special interest (AESI)

Timeframe: 7 days

Trial details

NCT IDNCT04919798

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-28

View on ClinicalTrials.gov More Urinary Retention trials

Plain-language summary

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.