Urinary CatheterizationPhase 3REPOURT-PNCT04159077
REduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial
A Phase 3 study testing Tamsulosin Hydrochloride in people with Urinary Catheterization and Thoracic Surgery, run by McMaster University.
Trial summary
The purpose of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing thoracic surgery. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Urinary Catheterization, Thoracic Surgery, Thoracic Epidural Analgesia
- What is being tested?
- Tamsulosin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2021to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively.
- OR
- Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively
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)
- Underlying neurological disorders resulting in impaired bladder function
- Any known contraindication to the use of tamsulosin HCL
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial
The purpose of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing thoracic surgery.
Read the detailed description
Post-operative urinary retention (POUR) is not an uncommon complication following thoracic surgery. It has been reported to occur in up to 12-67% of patients with the use of thoracic epidural analgesia1. Risk factors associated with urinary retention in thoracic patients include male, age over 40 years, type 2 diabetes, undergoing lung resection and the use of thoracic epidural analgesia2. Patients who experience urinary retention are treated with a straight catheter and may subsequently require the placement of an indwelling catheter. The use of these catheters is associated with numerous complications. The best studied complications are infectious and include catheter associated urinary tract infections (CAUTIs). However, many patients continue to experience symptoms well after their catheters have been removed.
Tamsulosin is an alpha one adrenergic receptor blocked that is indicated for the treatment of lower urinary tract symptoms in the context of benign prostatic hyperplasia. However, it is often used in clinical practice to treat other pathologies such as acute urinary retention and nephrolithiasis.
The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and catheter related complications in people undergoing thoracic surgery.
- Being tested
- Tamsulosin Hydrochloride, Placebos
- Keywords
- Post-operative urinary retention, Tamsulosin, urinary tract infections, catheter
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin HydrochlorideDrug
Tamsulosin HCL is an alpha blocker. It relaxes the muscles in the prostate and bladder neck, making easier to urinate. The dosage used will be 0.4 mg (administered once daily)
Other names: Flomax
PlacebosDrug
Half of the patients will be assigned to receive placebo tablets in the same manner as the active intervention. These tablets will have no effect.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin Hydrochloride (HCL) | Experimental | Consenting patients undergoing pulmonary resection will receive a 5-day allotment of tamsulosin HCL to be started 3 days prior to their date of surgery. Receives: Drug: Tamsulosin Hydrochloride |
| Placebo | Placebo comparator | Consenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative urinary retention (POUR)
Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period.
Measured: 0-24 hours
Secondary outcomes (6)
Rate and number of straight catheterizations
Rate and number of straight catheterizations
Measured: 0-7 days
Rate of indwelling catheterization
Rate of indwelling catheterization
Measured: 0-7 days
Time to first catheterization
Time to first catheterization
Measured: 0-24 hours
Treatment emergent Adverse Events
Treatment emergent Adverse Events as reported by the FDA (the Federal Drug Administration )
Measured: -3 days to 2 days
Rates of catheter complications within 30 days of catheterization
e.g. CAUTI, Urethral Trauma, Hematuria, urethral stricture
Measured: 0 to 30 days
Duration of hospital length of stay
Date of admission to date of discharge
Measured: 0 to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start30 Jul 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary CatheterizationStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaron Shargall, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159077
- Sponsor's protocol ID
- SJHH_REPOURT_P
- Acronym
- REPOURT-P
- Status last verified
- Jan 2021
- First submitted
- 7 Nov 2019
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PubMed 26897642Kim KW, Lee JI, Kim JS, Lee YJ, Choi WJ, Jung H, Park KY, Park CH, Son KH. Risk factors for urinary retention following minor thoracic surgery. Interact Cardiovasc Thorac Surg. 2015 Apr;20(4):486-92. doi: 10.1093/icvts/ivu445. Epub 2015 Jan 6.
PubMed 25564576Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018 Aug 1;178(8):1078-1085. doi: 10.1001/jamainternmed.2018.2417.
PubMed 29971436Shokrpour M, Shakiba E, Sirous A, Kamali A. Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery. J Family Med Prim Care. 2019 Feb;8(2):722-727. doi: 10.4103/jfmpc.jfmpc_18_19.
PubMed 30984702Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017.
PubMed 28584678
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Post-Operative Urinary Retention With Tamsulosin Versus Placebo (REPOURT- P) Trial
- ClinicalTrials.gov ID
- NCT04159077
- Acronym / sponsor ID
- REPOURT-P / SJHH_REPOURT_P
- Keywords
- Post-operative urinary retention, Tamsulosin, urinary tract infections, catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Nov 2019 (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 purpose of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing thoracic surgery.
Detailed description
Post-operative urinary retention (POUR) is not an uncommon complication following thoracic surgery. It has been reported to occur in up to 12-67% of patients with the use of thoracic epidural analgesia1. Risk factors associated with urinary retention in thoracic patients include male, age over 40 years, type 2 diabetes, undergoing lung resection and the use of thoracic epidural analgesia2. Patients who experience urinary retention are treated with a straight catheter and may subsequently require the placement of an indwelling catheter. The use of these catheters is associated with numerous complications. The best studied complications are infectious and include catheter associated urinary tract infections (CAUTIs). However, many patients continue to experience symptoms well after their catheters have been removed.
Tamsulosin is an alpha one adrenergic receptor blocked that is indicated for the treatment of lower urinary tract symptoms in the context of benign prostatic hyperplasia. However, it is often used in clinical practice to treat other pathologies such as acute urinary retention and nephrolithiasis.
The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and catheter related complications in people undergoing thoracic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin Hydrochloride (HCL) | Experimental | Drug: Tamsulosin HydrochlorideConsenting patients undergoing pulmonary resection will receive a 5-day allotment of tamsulosin HCL to be started 3 days prior to their date of surgery. |
| Placebo | Placebo comparator | Drug: PlacebosConsenting patients undergoing pulmonary resection will receive a 5-day allotment of placebo to be started 3 days prior to their date of surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients greater than the age of 40 and/or with type 2 diabetes undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively.
- OR
- Male patients receiving a thoracic epidural analgesia undergoing pulmonary surgery who did not undergo straight or indwelling urinary catheterization intraoperatively
Key exclusion criteria (8 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 HydrochlorideTamsulosin HCL is an alpha blocker. It relaxes the muscles in the prostate and bladder neck, making easier to urinate. The dosage used will be 0.4 mg (administered once daily) Other names: Flomax | Drug | Tamsulosin Hydrochloride (HCL) |
| PlacebosHalf of the patients will be assigned to receive placebo tablets in the same manner as the active intervention. These tablets will have no effect. | Drug | Placebo |
Primary outcome
Rate of post-operative urinary retention (POUR)
Time frame: 0-24 hours
Rate of POUR; defined as requiring straight or indwelling catheterization at any point in the post-operative period.
6 secondary outcomes
Rate and number of straight catheterizations
Time frame: 0-7 days
Rate of indwelling catheterization
Time frame: 0-7 days
Time to first catheterization
Time frame: 0-24 hours
Treatment emergent Adverse Events
Time frame: -3 days to 2 days
Rates of catheter complications within 30 days of catheterization
Time frame: 0 to 30 days
Duration of hospital length of stay
Time frame: 0 to 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Background: PubMed 26897642Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
- Background: PubMed 25564576Kim KW, Lee JI, Kim JS, Lee YJ, Choi WJ, Jung H, Park KY, Park CH, Son KH. Risk factors for urinary retention following minor thoracic surgery. Interact Cardiovasc Thorac Surg. 2015 Apr;20(4):486-92. doi: 10.1093/icvts/ivu445. Epub 2015 Jan 6.
- Background: PubMed 29971436Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA Intern Med. 2018 Aug 1;178(8):1078-1085. doi: 10.1001/jamainternmed.2018.2417.
- Background: PubMed 30984702Shokrpour M, Shakiba E, Sirous A, Kamali A. Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery. J Family Med Prim Care. 2019 Feb;8(2):722-727. doi: 10.4103/jfmpc.jfmpc_18_19.
- Background: PubMed 28584678Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017.
- 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. This study is not recruiting at the moment.
Yaron Shargall, MD, PhD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin Hydrochloride in people with Urinary Catheterization and Thoracic Surgery, run by McMaster University.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Housne Begum, PhD ((905)522-1155 ext. 35338, begumh@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-operative urinary retention (POUR) (time frame: 0-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04159077, which also lists 5 linked publications.
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 25 Feb 2021.