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Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH

21. august 2021 oppdatert av: Kyo Chul Koo, Gangnam Severance Hospital

A Prospective, Randomized, Open Label, Parallel Trial Comparing the Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With Benign Prostatic Hyperplasia

The investigators compare the efficacy of alpha-blocker and 5-ARI withdrawal to continued combination therapy on the maintenance of LUTS and improvement of quality of life outcomes in men with benign prostatic hyperplasia.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Benign Prostatic Hyperplasia (BPH) is the primary cause of lower urinary tract symptoms (LUTS). Combination therapy with an alpha-blocker and 5α reductase inhibitors (5-ARI) is the first-line treatment of BPH-related LUTS for the reduction of the size of the prostate and LUTS improvement. Combination therapy is tolerated well by most men; however, the incidence of adverse events is higher than with either therapy alone. In patients with improved LUTS following combination therapy, the aim of this study is based on the hypothesis that the withdrawal of either therapy will not increase the risk of LUTS aggravation while improving the quality of life.

The investigators plan a prospective, randomized, open-label, parallel trial, comparing alpha-blocker withdrawal and 5-ARI withdrawal to continued combination therapy. Treatments will be allocated in a 1:1:1 ratio, based on IPSS score (≤30% decrease from baseline) and prostate volume (≤35% decrease from baseline).

Studietype

Intervensjonell

Registrering (Forventet)

300

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

  • Navn: Kyo Chul Koo, MD, PhD
  • Telefonnummer: 82-01099480342
  • E-post: gckoo@yuhs.ac

Studer Kontakt Backup

  • Navn: Kwang Suk Lee, MD, MMS
  • Telefonnummer: 82-01089246674
  • E-post: calmenow@yuhs.ac

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 135-720
        • Rekruttering
        • Gangnam Severance Hospital, Yonsei University College of Medicine
        • Ta kontakt med:
          • Kyo Chul Koo, MD, PhD
          • Telefonnummer: 82-01099480342
          • E-post: gckoo@yuhs.ac
        • 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 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Men aged ≥50 or <80 years AND
  • On combination therapy (alpha-blocker and 5-ARI) ≥12 months AND
  • IPSS score (≤30% decrease from baseline) AND
  • Prostate volume (≤35% decrease from baseline)

Exclusion Criteria:

  • Suspected prostate cancer (PSA density >0.15 ng/ml/cc) requiring specific management
  • On-going prostatitis or urinary retention
  • Acontractile detrusor
  • Neurogenic lower urinary tract dysfunction
  • Urethral stenosis
  • Patient unable or unwilling to provide written informed consent

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: alpha-blocker withdrawal
receives 5-ARI monotherapy
Legemiddel: alpha-blocker or 5-ARI withdrawal
Withdrawal of either alpha-blocker or 5-ARI
Andre navn:
  • alpha-blocker withdrawal
  • 5-ARI withdrawal
Eksperimentell: 5-ARI withdrawal
receives alpha-blocker monotherapy
Legemiddel: alpha-blocker or 5-ARI withdrawal
Withdrawal of either alpha-blocker or 5-ARI
Andre navn:
  • alpha-blocker withdrawal
  • 5-ARI withdrawal
Aktiv komparator: combination therapy
receives alpha-blocker and 5-ARI
Legemiddel: Maintenance of alpha-blocker and 5-ARI
Maintenance of alpha-blocker and 5-ARI

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in International Prostate Symptom Score (IPSS) score from baseline
Tidsramme: 18 months
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS is self-administered at screening and each time-point of month 3, 6, 12, and 18. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). Month 18 is the primary timepoint and earlier timepoints are considered secondary. Change from baseline defined as difference between post-baseline value and baseline value.
18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of adverse events
Tidsramme: 3, 6, 12, 18 months
Adverse events includes; dizziness, headache, pounding heartbeat, weakness. decreased sexual desire, impotence, ejaculatory disorder, gynecomastia, depression, and anxiety.
3, 6, 12, 18 months
Change in International Prostate Symptom Score (IPSS) from baseline
Tidsramme: 3, 6, 12 months
IPSS is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS is self-administered at screening and each time-point of month 3, 6, and 12. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). Change from baseline defined as difference between post-baseline value and baseline value.
3, 6, 12 months
Change in Overactive bladder symptom score (OABSS) from baseline
Tidsramme: 3, 6, 12, 18 months
The OABSS is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score. The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points). OABSS is self-administered at screening and each time-point of month 3, 6, 12 and 18. Change from baseline defined as difference between post-baseline value and baseline value.
3, 6, 12, 18 months
Change in EuroQol five dimension scale (EQ-5D) score from baseline
Tidsramme: 3, 6, 12, 18 months
The EuroQol five dimension descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ-5D is self-administered at screening and each time-point of month 3, 6, 12 and 18. Change from baseline defined as difference between post-baseline value and baseline value.
3, 6, 12, 18 months
Change in Qmax from baseline
Tidsramme: 3, 12, 18 months
The measurement of maximum urinary flow rate (Qmax) is widely used in the assessment of men complaining of lower urinary tract symptoms. Qmax is performed at screening and each time-point of month 3, 12, and 18. Change from baseline defined as difference between post-baseline value and baseline value.
3, 12, 18 months
Change in prostate volume from baseline
Tidsramme: 18 months
The measurement of prostate volume is performed at screening and at month 18. Change from baseline defined as difference between post-baseline value and baseline value.
18 months
Change in prostate-specific antigen (PSA) level from baseline
Tidsramme: 18 months
The measurement of prostate-specific antigen (PSA) level is performed at screening and at month 18. Change from baseline defined as difference between post-baseline value and baseline value.
18 months

Samarbeidspartnere og etterforskere

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

Sponsor

Gangnam Severance Hospital

Etterforskere

  • Hovedetterforsker: Kyo Chul Koo, MD, PhD, Yonsei University

Publikasjoner og nyttige lenker

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Faktiske)

8. desember 2020

Primær fullføring (Forventet)

7. desember 2023

Studiet fullført (Forventet)

7. desember 2023

Datoer for studieregistrering

Først innsendt

15. august 2021

Først innsendt som oppfylte QC-kriteriene

21. august 2021

Først lagt ut (Faktiske)

27. august 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 3-2020-0451 (Annet stipend/finansieringsnummer: Handok Pharmaceutical)

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

produkt produsert i og eksportert fra USA

Ja

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