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NCT04994431: POUR

Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin

Terminated Phase 4 Results posted Last updated 7 November 2024
What this trial tests

Phase 4 trial testing Tamsulosin Hydrochloride in Thoracic Diseases in 109 participants. Terminated before completion.

Timeline
1 August 2021
Primary endpoint
4 October 2023
4 October 2023

Quick facts

Lead sponsorUniversity of Massachusetts, Worcester
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment109
Start date1 August 2021
Primary completion4 October 2023
Estimated completion4 October 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Massachusetts, Worcester

Who can join

60 and older, male only, with Thoracic Diseases or Urinary Retention. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Post-Operative Urinary Retention (Pour) Primary · 5 days

Proportion of Participants experiencing Post-Operative Urinary Retention (POUR) following thoracic surgery as compared to historic controls.

GroupValue95% CI
Perioperative Tamsulosin Hydrochloride1
Historical Comparator32

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 Days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Perioperative Tamsulosin Hydrochloride
Serious: 1/7 (14%)
Deaths: 0/7
Historical Comparator
Serious: 0/101 (0%)
Deaths: 0/101

Serious adverse events (1 terms)

ReactionSystemPerioperative Tamsulosin H…Historical Comparator
AspirationRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Aspiration.

Data from ClinicalTrials.gov NCT04994431 adverse events section.

Sponsor's own description

Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Tamsulosin Hydrochloride

Trials testing the same drug.

Other recruiting trials for Thoracic Diseases

Currently open trials in the same condition.

Other University of Massachusetts, Worcester trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04994431.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing