First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study (NIBED pilot)
9. juni 2022 opdateret af: University Hospital Inselspital, Berne
Randomized, Controlled, Cross-over, First-in-man Safety and Efficacy Trial of a Novel Non-invasive Bladder Emptying Device: The NIBED Study
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Bern, Schweiz, 3010
- Bern University Hospital Inselspital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Urinating with NIBED first, without NIBED second
|
The NIBED is applied to the penis during urination to support bladder emptying in urinary retention patients.
It is a battery-driven handheld device that is operated by the patient himself.
Andre navne:
|
|
Eksperimentel: Urinating without NIBED first, with NIBED second
|
The NIBED is applied to the penis during urination to support bladder emptying in urinary retention patients.
It is a battery-driven handheld device that is operated by the patient himself.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Penile pain
Tidsramme: 7 days
|
Assessment of penile pain (reported as numeric pain rating scale (NPRS): 0 (no pain at all) to 10 (worst imaginable pain))
|
7 days
|
|
Penile lesions
Tidsramme: 7 days
|
Assessment of penile lesions (visually assessed and reported as numeric rating scale (NRS): 0 (none) to 5 (exposed urethra))
|
7 days
|
|
Hematuria
Tidsramme: 7 days
|
Assessment of hematuria (dipstick urinalysis, scale: negative, 1+, 2+, 3+, 4+, macrohematuria (visible))
|
7 days
|
|
Number of patients with adverse events of special interest (AESI)
Tidsramme: 7 days
|
Number of patients with adverse events of special interest (AESI)
|
7 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Voided urine volume
Tidsramme: 1 day
|
Assessment of voided urine volume, measured by uroflowmeter/scale [ml]
|
1 day
|
|
Residual volume
Tidsramme: 1 day
|
Assessment of residual volume, measured with ultrasound bladder scanner [ml]
|
1 day
|
|
Voiding time
Tidsramme: 1 day
|
Assessment of voiding time, measured with clock [s]
|
1 day
|
|
Urine flow rate
Tidsramme: 1 day
|
Assessment of urine flow rate, measured with uroflowmeter [ml/s]
|
1 day
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Usability of the device
Tidsramme: 1 day
|
Assessment of usability and device acceptance, measured with a patient questionnaire (multiple choice questions and likert scale)
|
1 day
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Bernhard Kiss, Department of Urology
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. juli 2021
Primær færdiggørelse (Faktiske)
28. april 2022
Studieafslutning (Faktiske)
28. april 2022
Datoer for studieregistrering
Først indsendt
27. maj 2021
Først indsendt, der opfyldte QC-kriterier
3. juni 2021
Først opslået (Faktiske)
9. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juni 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juni 2022
Sidst verificeret
1. juni 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CIP_NIBED_V1-8
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .