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

NCT04994431 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: H00018178
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Diseases; Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Participants With Post-Operative Urinary Retention (Pour)

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

  5 days

Study Arms (2)

Perioperative Tamsulosin Hydrochloride

EXPERIMENTAL

Participants undergoing thoracic surgery will receive 0.4mgTamsulosin Hydrochloride orally nightly for the two nights immediately prior to surgery and the morning of surgery.

Drug: Tamsulosin Hydrochloride

Historical Comparator

NO INTERVENTION

Participants who underwent thoracic surgery (historical). Information about occurrence of Peri-Operative Urinary Retention in thoracic surgery patients will be obtained via retrospective chart review.

Interventions

Tamsulosin Hydrochloride DRUG

0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.

Perioperative Tamsulosin Hydrochloride

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All male patients \>=60 years old who undergo inpatient thoracic surgery for major resections.

You may not qualify if:

• \- Prisoners
• Adults unable to consent
• End stage renal disease on hemodialysis
• Indwelling urinary catheter
• Child-Pugh class C hepatic failure
• Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine
• patients known to be CYP2D6 poor metabolizers
• History of prostatectomy or cystectomy
• Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• UMass Memorial Health: collaborator

Study Sites (1)

UMass Memorial Healthcare, Inc.

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Thoracic Diseases; Urinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Difficulty with recruitment.

Results Point of Contact

• Title: Feiran Lou
• Organization: UMass Memorial Health Care

feiran.lou@umassmemorial.org

5083348996

Study Officials

• Feiran Lou, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects that sign a study consent and meet inclusion and exclusion criteria will receive the the study drug.

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: August 1, 2021
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)