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NCT Number: NCT06262048

Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location status: Recruiting

Location contact

Rahul Nayak, MD MSc

CONTACT

[email protected]

519-685-8500 ext. 56927

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin Hydrochloride

Drug

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

Other names: tamsulosin HCL

Placebo

Other

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

Primary outcomes

  1. Enrollment Effectiveness

    Time frame: 4 months

    Percentage of Screen eligible patients consenting to the study

  2. Monthly recruitment

    Time frame: 4 months

    Rate of monthly recruitment

  3. Protocol adherence

    Time frame: 4 Months

    Percentage of enrolled patient adherent to protocol during intervention phase

Secondary outcomes

  1. Rate of Straight Catheterizations

    Time frame: 30 days post-op

    Number of Single urinary catheterizations performed

  2. Rate of Indwelling Catheterizations

    Time frame: 30 days post-op

    Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay

  3. Time to first catheterization

    Time frame: up to 30 days post-op

    Time to first catheterization

  4. Treatment Related Adverse Events

    Time frame: 30 days post-op

    Unexpected or noxious events that occur as a result of or suspected to be a result of use of the study drug.

  5. Catheter related complications

    Time frame: 30 days post-op

    Rates of catheter related complications within 30 days of catheterization (e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture)

  6. Length of stay

    Time frame: 30 days post-op

    Duration of hospital length of stay will be measured by collecting the date of admission and the date of discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Deb Lewis

CONTACT

[email protected]

519-685-8500 ext. 75685

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: PrePOURTS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 15, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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