- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02529371
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
Studieoversigt
Detaljeret beskrivelse
Following various disease conditions such as trauma, orthopedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. Others may be incontinent of urine. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated; in many cases a catheter is placed despite lack of urinary retention. Indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. In other cases diapers or absorbent pads may be used, or a condom-type urine collection device. These may be associated with skin irritation and infection.
The study will evaluate the UriCap-RM non-invasive urine collection device in hospitalized men.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male ≥ 18 years old.
- Empties the bladder completely on voiding
- A clinical indication for an indwelling catheter, use of pads or diapers
- Subject has signed an informed consent form, is cooperative and willing to complete all study procedures
- Absence of localized disease at the site of device application - no discharge, itching, inflammation or skin condition - - on visual examination
- Subject has no hypersensitivity to silicon.
Exclusion Criteria:
- Known allergy to silicon
- Dysuria
- Urinary retention - Post-void residual urine more than 300cc
- Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement.
- Diagnosed with acute renal failure, according to investigator judgement.
- Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the subject's well-being or successful participation in the study
- Participating in another clinical study.
- Financial interest in the Sponsor Company or a competitor company by subject or a family member
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: UriCap-RM
The device is comprised of a reusable part and a single use adhesive tape.
The device is removed once daily and the reusable part is rinsed, dried and reapplied with a new adhesive tape.
|
UriCap-RM is comprised of a reusable part and a single use adhesive tape.
The reusable part is applied over the urethral meatus and is held in position by a stabilizer and adhesive tape.
It is connected to a standard urine collection bag.
The UriCap-RM is used on male patients who would otherwise use diapers, a condom-type urine collection device or an indwelling catheter for urine collection.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Performance of the device in collecting urine
Tidsramme: 1-30 days
|
Multiple variables will be assessed and their measurements aggregated to arrive at number of events reported:
|
1-30 days
|
Patient Comfort
Tidsramme: 1-30 days
|
Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
|
1-30 days
|
Healthcare provider (HCP) satisfaction in device use
Tidsramme: up to 60 days
|
Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
|
up to 60 days
|
Patient Satisfaction in Device Use
Tidsramme: 1-30 days
|
Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.
|
1-30 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Effectiveness of defined device cleaning procedure
Tidsramme: 1-30 days
|
The reusable part will be visually inspected after cleaning for suitability for reuse.
Devices which exhibit any of the following properties will be discarded: color change, residual soiling, loss of mechanical integrity, torn, rough edges.
The effectiveness of the cleaning procedure will be measured as the average number of days the device can be reused.
|
1-30 days
|
Number of leakage events resulting from device movement
Tidsramme: 1-30 days
|
1-30 days
|
|
Number of patients with Adverse Events that are related to device use
Tidsramme: 1-30 days
|
1-30 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Elad Schiff, MD, no affiliation
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GRD-01M
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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 .
Kliniske forsøg med Ufrivillig vandladning
-
Neuspera Medical, Inc.Aktiv, ikke rekrutterendeUrinary Urgency InkontinensForenede Stater, Holland, Belgien
-
Oregon Health and Science UniversityAfsluttetUrinary Urgency InkontinensForenede Stater
-
NovaBay Pharmaceuticals, Inc.UkendtUrinary Catheter Blokering og EncrustationForenede Stater
-
TC Erciyes UniversityAfsluttet
-
NovaBay Pharmaceuticals, Inc.AfsluttetUrinary Catheter Blokering og EncrustationForenede Stater
-
Seattle Urology Research CenterUkendtNocturia | Urinary Urgency | UrinhyppighedForenede Stater
-
Mayo ClinicNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeSmerte | Ondartet neoplasma | Urinary Urgency | Blære SpasmerForenede Stater
-
University of Sao PauloAfsluttetNyre Calculi | Urolithiasis | Urinary LithiasisBrasilien
-
University of California, San FranciscoNational Institute on Aging (NIA)AfsluttetOveraktiv blære | Hasteinkontinens | Urinary SymptomerForenede Stater
-
Northwestern UniversityAfsluttetNedre urinvejssymptomer | Ufrivillig vandladning | Angst | Bækkenbundslidelser | Nocturia | Urinary Urgency | Urinhyppighed/haster | Urin tøven | UrinbelastningForenede Stater
Kliniske forsøg med UriCap-RM
-
G.R. Dome Medical Ltd.UkendtUfrivillig vandladning
-
Assiut UniversityAfsluttetIntraoperative komplikationerEgypten
-
Purdue UniversityAfsluttetKardiovaskulær risikofaktor | Sund diætForenede Stater
-
Rhythm Pharmaceuticals, Inc.RekrutteringHypothalamus fedmeForenede Stater
-
University Hospital, Clermont-FerrandAfsluttetAcute respiratory distress syndromFrankrig
-
Region Örebro CountyÖrebro kommun; Kumla kommunTrukket tilbageUfrivillig vandladning | Urinvejsinfektioner | Kognitionsforstyrrelser i alderdommen | Inkontinens-associeret dermatitis | Adfærdsmæssige og psykiatriske symptomer på demensSverige
-
Steven J. HardyAfsluttetAnæmi, seglcelleForenede Stater
-
Rhythm Pharmaceuticals, Inc.AfsluttetFedme | HypertriglyceridæmiForenede Stater
-
Rhythm Pharmaceuticals, Inc.Aktiv, ikke rekrutterendeFedme forbundet med defekter i Leptin-melanocortin-vejenForenede Stater, Holland, Canada, Tyskland, Det Forenede Kongerige, Frankrig, Grækenland, Spanien
-
Mathys Ltd BettlachUkendtHofteudskiftning | Artropati af hofte