Recruiting
Phase 2

Observational Study

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT06262048

Conditions

Urinary Retention Postoperative

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Tamsulosin Hydrochloride

Placebo

Study Details

Brief summary:

The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery.

Conditions

Urinary Retention Postoperative

Study ID

NCT06262048

Start date

Oct 1, 2024

Status verified date

Oct, 2024

Completion date

Feb 1, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria ( 2 or more of the following risk factors):

  • Male Sex
  • Age greater than or equal to 40 years
  • History of Diabetes Mellitus
  • Prior pelvic irradiation
  • Use of indwelling Thoracic Epidural analgesia
  • Prior history of urinary retention

AND

International Prostate Specific Score greater than or equal to 1.

Exclusion Criteria:

  • Active treatment of Benign Prostatic Hyperplasia (BPH)
  • Hypersensitivity or allergy to tamsulosin HCL
  • Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date
  • Active urinary tract infection
  • History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy.
  • History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
  • Underlying neurological disorders resulting in impaired bladder function
  • Any known contraindication to the use of tamsulosin HCL
  • Nursing/ Breastfeeding women
  • Use of intraoperative bladder catheter
  • patients for whom cataract and/or glaucoma surgery is scheduled.
  • patients on strong inhibitors of CYP3A4 (e.g., ketoconazole), on moderate inhibitors of CYP3A4 (e.g., erythromycin), on strong (e.g. paroxetine), on moderate (e.g., terbinafine) inhibitors of CYP2D6 or in patients known to be CYP2D6 poor metabolizers.
  • patients with a serious or life-threatening sulfa allergy
  • patients with severe hepatic insufficiency
  • patients with severe renal impairment (creatinine clearance of <10 mL/min)
  • patients with a serious or life-threatening sulfa allergy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment

Tamsulosin

placebo comparator: Placebo

Placebo

Interventions

Tamsulosin Hydrochloride

2 days pre-op, day of surgery, 2 days post-op

Placebo

2 days pre-op, day of surgery, 2 days post-op

Primary outcome measure

  • Enrollment Effectiveness [ Time Frame: 4 months ]
  • Monthly recruitment [ Time Frame: 4 months ]
  • Protocol adherence [ Time Frame: 4 Months ]

Central Contacts and Locations

Central contacts

Deb Lewis

519-685-8500deb.lewis@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Rahul Nayak, MD MSc

519-685-8500rahul.nayak@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Oct 28, 2024

Last verified

Oct, 2024

Keywords

  • urinary retention
  • thoracic surgery
  • urinary catheter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-10-28.