Urinary Retention PostoperativePhase 2PrePOURTSNCT06262048
Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial
A Phase 2 study testing Tamsulosin Hydrochloride in people with Urinary Retention Postoperative, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Urinary Retention Postoperative
- What is being tested?
- Tamsulosin Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 1 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Rahul Nayak, MD MSc, 519-685-8500 ext. 56927, rahul.nayak@lhsc.on.ca
About this study
Official title: Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility 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.
Read the 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.
- Conditions
- Urinary Retention Postoperative
- Being tested
- Tamsulosin Hydrochloride, Placebo
- Keywords
- urinary retention, thoracic surgery, urinary catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin HydrochlorideDrug
Also called tamsulosin HCL
2 days pre-op, day of surgery, 2 days post-op
PlaceboOther
2 days pre-op, day of surgery, 2 days post-op
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Tamsulosin Receives: Drug: Tamsulosin Hydrochloride |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Effectiveness
Percentage of Screen eligible patients consenting to the study
Measured: 4 months
Monthly recruitment
Rate of monthly recruitment
Measured: 4 months
Protocol adherence
Percentage of enrolled patient adherent to protocol during intervention phase
Measured: 4 Months
Secondary outcomes (6)
Rate of Straight Catheterizations
Number of Single urinary catheterizations performed
Measured: 30 days post-op
Rate of Indwelling Catheterizations
Proportion of patients who have an indwelling foley catheter inserted during their post-operative stay
Measured: 30 days post-op
Time to first catheterization
Time to first catheterization
Measured: up to 30 days post-op
Treatment Related Adverse Events
Unexpected or noxious events that occur as a result of or suspected to be a result of use of the study drug.
Measured: 30 days post-op
Catheter related complications
Rates of catheter related complications within 30 days of catheterization (e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture)
Measured: 30 days post-op
Length of stay
Duration of hospital length of stay will be measured by collecting the date of admission and the date of discharge
Measured: 30 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Retention PostoperativeStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single centre, double blind randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Nayak, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Rahul Nayal, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262048
- Sponsor's protocol ID
- PrePOURTS
- Acronym
- PrePOURTS
- Status last verified
- Oct 2024
- First submitted
- 15 Jan 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post Operative Urinary Retention After Thoracic Surgery: A Phase II Feasbility Trial
- ClinicalTrials.gov ID
- NCT06262048
- Acronym / sponsor ID
- PrePOURTS / PrePOURTS
- Conditions
- Urinary Retention Postoperative
- Keywords
- urinary retention, thoracic surgery, urinary catheter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- single centre, double blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Tamsulosin HydrochlorideTamsulosin |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosin HydrochlorideAlso: tamsulosin HCL2 days pre-op, day of surgery, 2 days post-op | Drug | Treatment |
| Placebo2 days pre-op, day of surgery, 2 days post-op | Other | Placebo |
Primary outcome
Enrollment Effectiveness
Time frame: 4 months
Percentage of Screen eligible patients consenting to the study
Monthly recruitment
Time frame: 4 months
Rate of monthly recruitment
Protocol adherence
Time frame: 4 Months
Percentage of enrolled patient adherent to protocol during intervention phase
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul Nayal principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamsulosin Hydrochloride in people with Urinary Retention Postoperative, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deb Lewis (519-685-8500 ext. 75685, deb.lewis@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Effectiveness (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.