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Urolift Pre-SBRT for redusert urintoksisitet hos pasienter med BPH og prostatakreft.

24. september 2026 oppdatert av: Northwell Health

Reduksjon av urintoksisitet ved stereootaktisk strålebehandling (SBRT) med prostatisk urethralløft (Urolift)

Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • New York
      • Syosset, New York, Forente stater, 11791
        • Rekruttering
        • Northwell Health
        • Hovedetterforsker:
          • Bilal Chughtai, MD
        • Ta kontakt med:

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 til 99 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Subject is 50 - 99 years of age
  • Subject has provided informed consent
  • Subject has diagnosis of prostate cancer requiring SBRT
  • Subject is able to complete self-administered questionnaires
  • Subject is a surgical candidate for Urolift
  • Subject has a diagnosis of BPH
  • Medical record documentation of prostate volume from 30-80 ml by TRUS
  • Absence of a middle lobe

Exclusion Criteria:

  • Life expectancy < 2 years
  • Currently enrolled in or plans to enroll in any concurrent drug or device study
  • Concurrent androgen deprivation therapy
  • Has an active infection (e.g., urinary tract infection or prostatitis)
  • Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
  • Subject has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
  • Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
  • Diagnosis of lichen sclerosis
  • Neurogenic bladder or other neurologic disorder that affects bladder function
  • Diagnosis of polyneuropathy (e.g., diabetic)
  • History of lower urinary tract surgery
  • Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
  • Subject has been catheterized or has a PVR > 400 ml in the 14 days prior to the surgical procedure
  • Current diagnosis of bladder stones

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Urolift

This is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment.
Enhet: Urolift

Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in IPSS scores from baseline and one year post treatment
Tidsramme: At baseline and one year post treatment

Patients will take a International Prostatic Symptom Score (IPSS) questionnaire to evaluate symptom severity at baseline and 1 year post treatment. IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.
At baseline and one year post treatment
Change in IIEF score through study completion, an average of 1 year
Tidsramme: Through study completion, an average of 1 year

Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.
Through study completion, an average of 1 year
Change in MSHQ through study completion, an average of 1 year
Tidsramme: Through study completion, an average of 1 year

Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year.

Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.
Through study completion, an average of 1 year
Change in VAS score through study completion, an average of 1 year
Tidsramme: through study completion, an average of 1 year

Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.
through study completion, an average of 1 year
Change in OAB-SF score through study completion, an average of 1 year
Tidsramme: Through study completion, an average of 1 year

Patients will use a overactive bladder short form (OAB-SF) to describe their overactive bladder symptoms through study completion, an average of 1 year, to see if there is any changes in symptoms.

The OAB-q SF has 2 main subscales: Symptom bother and Health-Related Quality of Life (HRQOL). The two subscales are summed separately and transformed into scores ranging from 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity and a higher score on the HRQOL scale indicates a better HRQOL, so they are inversely related to each other. Since the OAB-q SF has no total score, higher scores indicate more severe symptoms or better quality of life, respectively. Lower scores indicate less severe symptoms or worse quality of life respectively.
Through study completion, an average of 1 year
Change in SF-12 score through study completion, an average of 1 year
Tidsramme: Through study completion, an average of 1 year

Patients will use a short form 12 (SF-12) survey to measure their quality of life through study completion, an average of 1 year, to see if there is any changes.

Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.
Through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in medication usage through study completion, an average of 1 year
Tidsramme: Through study completion, an average of 1 year

Patients will list their medication usage through study completion, an average of 1 year to see if there is any changes in medications after the study treatment
Through study completion, an average of 1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Northwell Health

Samarbeidspartnere

Teleflex
NeoTract, Inc.

Etterforskere

  • 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.

Generelle publikasjoner

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)

11. februar 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. mars 2028

Datoer for studieregistrering

Først innsendt

23. november 2021

Først innsendt som oppfylte QC-kriteriene

6. desember 2021

Først lagt ut (Faktiske)

8. desember 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 24-0684

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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