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Prevention study for Urinary Retention Postoperative
Official title Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
ClinicalTrials.gov ID: NCT06262048
What this study is testing
What is Tamsulosin Hydrochloride?
Tamsulosin Hydrochloride is an investigational medicine, being studied as a potential treatment for urinary retention postoperative.
Also referred to as tamsulosin HCL.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- ( 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
You likely can't join if
- 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)
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.