Testing Tamsulosin Hydrochloride against a placebo for urinary retention postoperative
Official title: Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility Trial
- Phase 2
- 2 groups
- One site, in London
- Recruiting
Interventions
- Medication
Tamsulosin Hydrochloride
2 days pre-op, day of surgery, 2 days post-op
- Other intervention
Placebo
2 days pre-op, day of surgery, 2 days post-op
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +( 2 or more of the following risk factors):
- +Age greater than or equal to 40 years
- +History of Diabetes Mellitus
- +Use of indwelling Thoracic Epidural analgesia
- +Prior history of urinary retention
- +International Prostate Specific Score greater than or equal to 1.
- +Prior pelvic irradiation
Exclusion
- −Hypersensitivity or allergy to tamsulosin HCL
- −patients with a serious or life-threatening sulfa allergy
- −patients with a serious or life-threatening sulfa allergy
- −Active treatment of Benign Prostatic Hyperplasia (BPH)
- −Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → date
- −Active urinary tract infection
- −History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy.
- −Underlying neurological disorders resulting in impaired bladder function
- −Any known contraindication to the use of tamsulosin HCL
- −Use of intraoperative bladder catheter
- −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 severe hepatic insufficiency
- −patients with severe renal impairment (creatinine clearance of \<10 mL/min)
- −Nursing/ Breastfeeding women
- −History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy)
- −patients for whom cataract and/or glaucoma surgery is scheduled.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Tamsulosin Hydrochloride.
Registry label: A: Treatment
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around February 2026.
The main measurement is taken over: 4 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
EnrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → Effectiveness — measured over 4 months.
Monthly recruitment — measured over 4 months.
ProtocolProtocolThe detailed plan a study must follow.Read more → adherence — measured over 4 Months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06262048 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Tamsulosin HydrochlorideDrug
2 days pre-op, day of surgery, 2 days post-op
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
2 days pre-op, day of surgery, 2 days post-op
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 4 months.
The study as a whole is currently expected to finish around 2026-02-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This 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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.