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Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia (TAMS-TAD-TWOC)

12. juni 2026 opdateret af: Hany Fathy Badawy, MD, Beni-Suef University

Tamsulosin With Versus Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Prospective Double-Blind Randomized Trial

Acute urinary retention is a common emergency in men with benign prostatic hyperplasia. After bladder drainage with a urethral catheter, patients usually undergo a trial without catheter to determine whether they can pass urine again without recatheterization.

This study will evaluate whether adding tadalafil 5 mg once daily to tamsulosin 0.4 mg once daily improves the chance of successful trial without catheter in men with first-episode acute urinary retention due to presumed benign prostatic hyperplasia.

Participants will be randomly assigned to receive either tamsulosin plus tadalafil or tamsulosin plus a matching placebo. Study medication will start within 24 hours after catheterization. The catheter will be removed on Day 7. If the first trial without catheter fails, the catheter will be reinserted and a second rescue trial without catheter will be performed on Day 14.

The main outcome is overall catheter-free success by Day 14. Participants will also be followed for recurrent urinary retention, post-void residual urine, urinary flow, catheter-related complications, drug-related adverse events, and the need for benign prostatic hyperplasia-related surgery within 3 months.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

320

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypten, 02456
        • Rekruttering
        • Department of Urology- Beni-Suef University Hospitals
        • Kontakt:
        • Ledende efterforsker:
          • Hany F Badawy, MD
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male patient aged 50 years or older.
  • First episode of spontaneous painful acute urinary retention.
  • Successful urethral catheterization at presentation.
  • Drained urine volume at presentation of at least 300 mL.
  • Clinical impression of benign prostatic obstruction or benign prostatic hyperplasia based on history, digital rectal examination, and/or ultrasound evidence of enlarged prostate.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Previous episode of acute urinary retention.
  • Chronic painless urinary retention phenotype.
  • Active urinary tract infection or sepsis.
  • Gross hematuria with clot retention.
  • Suspected or known urethral stricture.
  • Neurogenic bladder or major neurologic disease affecting voiding.
  • History of prostate cancer or bladder cancer.
  • Previous prostate surgery.
  • Current use of nitrates or guanylate cyclase stimulators.
  • Contraindication to tadalafil or tamsulosin.
  • Severe hypotension or unstable cardiovascular disease.
  • Severe renal impairment.
  • Severe hepatic impairment.
  • Current or recent use of phosphodiesterase type 5 inhibitors before enrollment.

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: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Tamsulosin Plus Placebo
Participants will receive tamsulosin 0.4 mg once daily plus a matching placebo once daily. Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.
Medicin: Tamsulosin
Tamsulosin 0.4 mg will be administered orally once daily as open-label background therapy in both study arms. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.
Medicin: Tadalafil Placebo
A matching placebo tablet will be administered orally once daily in the placebo comparator arm in addition to open-label tamsulosin 0.4 mg once daily. The placebo will be identical to tadalafil in appearance, packaging, and labeling to maintain blinding.
Eksperimentel: Tamsulosin Plus Tadalafil
Participants will receive tamsulosin 0.4 mg once daily plus tadalafil 5 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.
Medicin: Tamsulosin
Tamsulosin 0.4 mg will be administered orally once daily as open-label background therapy in both study arms. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.
Medicin: Tadalafil
Tadalafil 5 mg will be administered orally once daily in the experimental arm in addition to open-label tamsulosin 0.4 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Catheter-Free Success by Day 14
Tidsramme: Day 14
Proportion of participants who achieve successful spontaneous voiding after either the scheduled Day-7 trial without catheter or the rescue Day-14 trial without catheter. Success is defined as spontaneous voiding after catheter removal, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, no recatheterization within 24 hours after the relevant trial without catheter attempt, and remaining catheter-free until Day 14 for participants who initially pass the Day-7 trial without catheter.
Day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Successful Day-7 Trial Without Catheter
Tidsramme: Day 7
Proportion of participants who achieve successful spontaneous voiding after catheter removal on Day 7. Success is defined as spontaneous voiding, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, and no recatheterization within 24 hours.
Day 7
Successful Rescue Day-14 Trial Without Catheter Among Day-7 Failures
Tidsramme: Day 14
Proportion of participants who fail the Day-7 trial without catheter and subsequently achieve successful rescue trial without catheter on Day 14 using the same predefined success criteria: spontaneous voiding, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, and no recatheterization within 24 hours.
Day 14
Recurrent Acute Urinary Retention Within 30 Days
Tidsramme: 30 days
Proportion of participants who develop recurrent painful acute urinary retention requiring recatheterization within 30 days after randomization.
30 days
Need for Benign Prostatic Hyperplasia-Related Surgery Within 3 Months
Tidsramme: 3 months
Proportion of participants who require surgical intervention for benign prostatic hyperplasia or benign prostatic obstruction within 3 months after randomization.
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beni-Suef University

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)

8. juni 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BSU FMBSUREC07062026CBADAWY

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared publicly because the study includes individual-level urological and treatment-related clinical data, and participant-level data sharing is not currently included in the ethics approval or informed consent. Only aggregated, de-identified results will be reported in publications or presentations. Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University, and an appropriate data-sharing agreement.

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Kliniske forsøg med Benign prostatahyperplasi

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