Menu
Recruiting NCT06262048

Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

Phase II Interventional Urinary Retention Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tamsulosin Hydrochloride, Placebo.
Who it may be relevant to
Registry conditions: Urinary Retention Postoperative. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility Trial

Overview

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.

Detailed description

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. Primary outcomes being measured are the enrollment rate, protocol adherence rate and participant drop out.

Interventions

  • Drug Tamsulosin Hydrochloride
    2 days pre-op, day of surgery, 2 days post-op
  • Other Placebo
    2 days pre-op, day of surgery, 2 days post-op

Primary outcome measures

  • Enrollment Effectiveness [Time frame: 4 months]
  • Monthly recruitment [Time frame: 4 months]
  • Protocol adherence [Time frame: 4 Months]
Secondary outcome measures (6)
  • Rate of Straight Catheterizations [Time frame: 30 days post-op]
  • Rate of Indwelling Catheterizations [Time frame: 30 days post-op]
  • Time to first catheterization [Time frame: up to 30 days post-op]
  • Treatment Related Adverse Events [Time frame: 30 days post-op]
  • Catheter related complications [Time frame: 30 days post-op]
  • Length of stay [Time frame: 30 days post-op]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Canada · 1 center
  • London Health Sciences Centre — London

Identifiers

NCT: NCT06262048 · PrePOURTS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗