En randomisert, internasjonal studie for å vurdere sikkerheten til iTind sammenlignet med UroLift (MT-08)
25. september 2026 oppdatert av: Olympus Corporation of the Americas
En ettermarkedet, prospektiv, randomisert, kontrollert, multisenter internasjonal studie for å vurdere sikkerheten til den midlertidig implanterte Nitinol-enheten (iTind) sammenlignet med UroLift®-systemet hos personer med symptomatisk benign prostatahyperplasi (BPH)
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen.
This study is designed to directly compare the safety and effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.
Studietype
Intervensjonell
Registrering (Antatt)
256
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Melanie Bonds, MS
- Telefonnummer: +1-703-851-4615
- E-post: Melanie.Bonds@olympus.com
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Rekruttering
- Mayo Clinic Arizona
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Hovedetterforsker:
- Mitchell Humphreys, MD
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Ta kontakt med:
- Rev Vilasan Shylaja
- Telefonnummer: 480-574-1466
- E-post: VilasanShylaja.Revathy@mayo.edu
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Tucson, Arizona, Forente stater, 85704
- Avsluttet
- Arizona Urology Specialists
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California
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Fresno, California, Forente stater, 93720
- Rekruttering
- Urology Associates of Central California
-
Hovedetterforsker:
- William Schiff, MD
-
Ta kontakt med:
- Joe Vidal
- Telefonnummer: 559-321-2919 559-720-3646
- E-post: jvidal@urologyassociates.net
-
Sacramento, California, Forente stater, 95823
- Rekruttering
- Golden State Urology
-
Hovedetterforsker:
- Prithipal Sethi, MD
-
Ta kontakt med:
- Sehaj Sethi
- Telefonnummer: 308 916-245-8888
- E-post: ssethi@goldenstateurology.com
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Illinois
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Evanston, Illinois, Forente stater, 60201
- Avsluttet
- NorthShore University Health System Research Institute
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Louisiana
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New Orleans, Louisiana, Forente stater, 70119
- Aktiv, ikke rekrutterende
- Southeast Louisiana Veterans Health Care System
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Minnesota
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Woodbury, Minnesota, Forente stater, 55125
- Tilbaketrukket
- Minnesota Urology
-
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Nebraska
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Omaha, Nebraska, Forente stater, 68124
- Rekruttering
- The Urology Center
-
Hovedetterforsker:
- Sida Niu, MD
-
Ta kontakt med:
- Amy Nelson
- Telefonnummer: 402-397-7989
- E-post: anelson@adultpediatricuro.com
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Nevada
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Las Vegas, Nevada, Forente stater, 89121
- Rekruttering
- Pacific West Urology
-
Ta kontakt med:
- John Dull
- Telefonnummer: 702-321-8045
- E-post: john.dull@pacificwesturology.com
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Hovedetterforsker:
- Joel Abbott, MD
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New York
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Syosset, New York, Forente stater, 11791
- Rekruttering
- Feinstein Institutes for Medical Research / Northwell Health
-
Hovedetterforsker:
- Bilal Chughtai, MD
-
Ta kontakt med:
- Jennifer Polo
- Telefonnummer: 516-628-5926
- E-post: jpolo1@northwell.edu
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Tennessee
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Germantown, Tennessee, Forente stater, 38138
- Rekruttering
- The Conrad Pearson Clinic
-
Hovedetterforsker:
- Adam Stewart, MD
-
Ta kontakt med:
- Jessica Parks
- Telefonnummer: 901-464-2711
- E-post: jessica.parks@conradpearson.com
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Texas
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Austin, Texas, Forente stater, 78705
- Rekruttering
- Midtown Urology Associates
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Hovedetterforsker:
- Tyler McClintock, MD
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Ta kontakt med:
- Andrew Barger
- Telefonnummer: 512-451-7935
- E-post: APBarger@cimplify.net
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Houston, Texas, Forente stater, 77027
- Rekruttering
- Houston Metro Urology
-
Ta kontakt med:
- Lena Ellis
- Telefonnummer: 713-634-4405
- E-post: lena.ellis@hmutx.com
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Hovedetterforsker:
- Mark Sutton, MD
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San Antonio, Texas, Forente stater, 78240
- Rekruttering
- The Urology Place
-
Hovedetterforsker:
- Naveen Kella, MD
-
Ta kontakt med:
- Raji Thiruppathiraj
- Telefonnummer: 210-617-3670
- E-post: raji@theupi.com
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Virginia
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Alexandria, Virginia, Forente stater, 22311
- Rekruttering
- Potomac Urology Center
-
Hovedetterforsker:
- Nilay Gandhi, MD
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Ta kontakt med:
- Chamin Lim
- Telefonnummer: 423 703-680-2111
- E-post: clim@potomacurology.com
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Dunfermline, Storbritannia, KY12 0SU
- Rekruttering
- Queen Margaret Hospital
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Hovedetterforsker:
- Feras Al Jaafari, MD
-
Ta kontakt med:
- Keith Boath
- Telefonnummer: 20951 +44-1383-623623
- E-post: Keith.boath@nhs.scot
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London, Storbritannia, GU16 7UJ
- Rekruttering
- Frimley Park Hospital
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Hovedetterforsker:
- Neil Barber, MD
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Ta kontakt med:
- Reynette Baroman
- E-post: r.baroman@nhs.net
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Norwich, Storbritannia, NR4 7UY
- Rekruttering
- Norfolk & Norwich University Hospital
-
Hovedetterforsker:
- Mark Rochester, MD
-
Ta kontakt med:
- Catherine Rennie
- Telefonnummer: +44-1603 646105
- E-post: catherine.rennie@nnuh.nhs.uk
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Middlesex
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Isleworth, Middlesex, Storbritannia, TW7 6AF
- Rekruttering
- Chelsea and Westminster Hospital
-
Hovedetterforsker:
- Samuel Bishara, MD
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Ta kontakt med:
- Farrah Akkouch
- Telefonnummer: +44 (0)20 321 5181
- E-post: chelwest.wmh.olympus@nhs.net
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
- Willing and able to provide informed consent
- Males ≥ 50 years of age or older
- PSA < 4 ng/ml or if the PSA is 4 - 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months
- Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be accepted up to 6 months prior to Screening
- International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 13
- Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL)
- Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits
Exclusion Criteria:
- History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months
- Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer
- History of acute bacterial prostatitis within the last 2 years
- Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
- PSA value > 10 ng/ml
- Contraindicated for iTind or UroLift as determined by the PI
- Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes or other neurological disorders that affect bladder function
- Clinically significant bladder diverticulum
- Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter
- Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease treatment if the therapy may potentially cause injury to site (e.g., if a transrectal probe is used), pelvic radiotherapy or radical pelvic surgery, urinary diversion surgery, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or any other invasive treatment to the prostate, or penile prosthesis if it may prevent insertion of the iTind or UroLift device
- An active urinary tract infection during randomization
- Clinically significant hematuria within the last 3 months or ongoing cystolithiasis
- Prostate volume > 75 cc
- Post-void residual volume (PVR) > 250 mL
- Actively using catheterization or unable to void naturally
- Unable to complete a 2-week washout period for alpha blockers prior to procedure or unable to discontinue 5ARIs or daily use of PDE5 inhibitors by the time of procedure
- Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure
- Known or suspected allergy to nickel, titanium or polyester/polypropylene
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: iTind arm
The iTind is a minimally invasive temporary implant |
The iTind is implemented for 5-7 days |
|
Aktiv komparator: UroLift
The UroLift is a minimally invasive permanent implant |
UroLift is a minimally invasive procedure where permanent implants are placed in the prostate. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
Tidsramme: 3 months
|
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months |
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months
Tidsramme: 12 month
|
Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months |
12 month
|
|
Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure.
Tidsramme: 3 month
|
Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure. |
3 month
|
|
Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months
Tidsramme: 1, 6, 24, and 36 months
|
Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months |
1, 6, 24, and 36 months
|
|
Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months
Tidsramme: 1, 3, 6, 12, 24, and 36 months
|
Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months |
1, 3, 6, 12, 24, and 36 months
|
|
Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, and 36 months
Tidsramme: 1, 3, 6, 12, 18, 24, and 36 months
|
Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, and 36 months |
1, 3, 6, 12, 18, 24, and 36 months
|
|
Difference in reporting between iTind and UroLift groups at 1, 6, 12, 18, 24, and 36, months •Overall incidence of procedure and/or device related adverse events
Tidsramme: 1, 6, 12, 18, 24, and 36, months
|
Difference in reporting between iTind and UroLift groups at 1, 6, 12, 18, 24, and 36, months •Overall incidence of procedure and/or device related adverse events |
1, 6, 12, 18, 24, and 36, months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Neil Barber, MD, Frimley Park Hospital
- Hovedetterforsker: Bilal Chughtai, MD, Northwell Health
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. september 2022
Primær fullføring (Antatt)
15. juli 2027
Studiet fullført (Antatt)
31. mai 2030
Datoer for studieregistrering
Først innsendt
7. februar 2021
Først innsendt som oppfylte QC-kriteriene
14. februar 2021
Først lagt ut (Faktiske)
17. februar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MT-08
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Ja
produkt produsert i og eksportert fra USA
Nei
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