Urinary RetentionPhase 3R-POURNCT05941806
Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection
A Phase 3 study testing pr Sandoz Tamsulosin and Glucose in people with Urinary Retention and Colorectal Surgery, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
The study will be a phase III double-blind randomized clinical trial. Participants will be recruited from the Department of General Surgery of the CHU de Québec - Saint-François-d'Assise and Hôtel-Dieu de Québec. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention, Colorectal Surgery, Rectal Resection
- What is being tested?
- pr Sandoz Tamsulosin and Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2023to 30 Jul 2028
- Phase
- Phase 3
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients
- 18 years and older
- Scheduled for rectal resection during the study period.
Who cannot join
- Patients undergoing revisional surgery
- Patients taking alpha-blocker medication,
- Patients who have an indwelling urinary catheter,
- Patients who have undergone urinary tract surgery,
- Patients who will have an intraoperative trauma of the urinary tract,
- Patients who will keep their urinary catheter for more than 24 hours after surgery,
- Patients who have an intolerance to alpha-blocking drugs or who take one of the following drugs (potential interaction): anti-retroviral, antifungal, clarithromycin, erythromycin, paroxetine, terbinafine, cimetidine, coumadin or phosphodiesterase inhibitors.
- Patients who will have an epidural anesthesia
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
Hôpital Saint-François d'Assise
Québec, Quebec, G1L 3L5
Beauchamp Frédérique, MD, 4182717881, frederique.beauchamp.1@ulaval.ca
About this study
Official title: Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection: a Double-blind Placebo-controlled Clinical Trial
The study will be a phase III double-blind randomized clinical trial. Participants will be recruited from the Department of General Surgery of the CHU de Québec - Saint-François-d'Assise and Hôtel-Dieu de Québec. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication.The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.
Read the detailed description
Participants will be recruited consecutively during their preoperative visit to the outpatient clinic. Participants will be followed by a logbook throughout the follow-up period, as well as by their surgical and research teams. Follow-up will begin on the first day of pre-operative medication and will end 30 days after surgery. Patients randomized to the intervention group will receive 0.4 mg tamsulosin capsules, administered orally, once a day for 5 days before surgery, the morning of surgery and the day after surgery. Patients assigned to the placebo group will receive glucose capsules according to the same protocol. The glucose capsules will be manufactured by the pharmacy of the CHU de Quebec. All patients will have a foley catheter inserted for surgery. Their urinary catheter (foley catheter) will be removed at 6:00 AM the day after their surgery (post-operative day 1). The diagnosis of urinary retention will be suspected by a member of the patient's medical team if a patient has no miction for 8 hours or more or 4 hours or more after removal of foley catheter or after the surgery. In these cases, a portable bladder scanner will be used. The diagnosis of post-operative urinary retention (POUR) will be confirmed in two situations: 1. If there is 500ml of urine or more in the bladder 2. If there is 300ml or urine or more with at least 1 of the following symptoms: urge to urinate with inability to urinate, suprapubic pain or signs and symptoms of delirium. When the diagnosis of POUR will be made, urine will be removed from the bladder using an in/out bladder catheterization. After using a bladder catheterization, a portable bladder scanner will be used again if a patient has no spontaneous urination for the first 4 hours after catheterization. A second bladder catheterization will be done once again in the same two situations as described above. At the third bladder catheterization, a urinary (foley) catheter will be inserted. The catheter will be left in place for 24h before attempting a trial of void. A member of the medical team will then collect the information in the patient's logbook and medical record. Adherence to drug intake will be self-reported to the patient's diary. The patient can indicate why he missed one or more doses of the drug. Patients will receive a list of potential side effects of tamsulosin with their logbook. The side effects will be self-reported by the patient to the logbook each day. The patients' logbook will be analysed by the research team. Two independent reviewers of the research team will collect the other variables. They will perform a standardized retrospective revision of the medical records according to a pre-established data collection grid. We will perform an intention-to-treat analysis in this prospective randomized study. Postoperative urinary retention remains a frequent complication and causes significant discomfort in men undergoing rectal resection. The decrease in its incidence could then significantly reduce the number of bladder catheterizations required postoperatively, and thus reduce the incidence of complications associated with it. The prevention of POUR will allow patients a more harmonious postoperative recovery, limited in inconvenience and side effects, and an earlier return home. Ultimately, the health care costs associated with this postoperative complication may be reduced.
- Conditions
- Urinary Retention, Colorectal Surgery, Rectal Resection, Post-operative Urinary Retention, Tamsulosin
- Being tested
- pr Sandoz Tamsulosin, Glucose
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pr Sandoz TamsulosinDrug
Also called Tamsulosin hydrochloride
Sandoz Tamsulosin, the study drug, is an alpha1-adrenergic blocking agent approved by Health Canada for men with bladder outlet obstruction symptoms associated with benign prostatic hyperplasia.
GlucoseDrug
Patients assigned to the placebo group will receive glucose capsules according to the same protocol. The glucose capsules will be manufactured by the pharmacy of the CHU de Quebec
| Study group | Role | What they receive |
|---|---|---|
| Group receiving Tamsulosin | Active comparator | Patients randomized to the intervention group will receive 0.4 mg tamsulosin capsules, administered orally, once a day for 5 days before surgery, the morning of surgery and the day after surgery. The steady-state plasma concentration of tamsulosin is reached after 4 to 5 consecutive doses, which justify the administration duration of 5 days preoperatively. The total duration of administration of tamsulosin was established at 7 days since the study of Patel et al. showed a significant reduction in POUR after 7 days of administration. Receives: Drug: pr Sandoz Tamsulosin |
| Group receiving Placebo | Placebo comparator | Patients assigned to the placebo group will receive glucose capsules according to the same protocol. The glucose capsules will be manufactured by the pharmacy of the CHU de Quebec. Receives: Drug: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative urinary retention
Incidence of postoperative urinary retention in men undergoing rectal resection
Measured: During the length of hospital stay: up to two weeks
Secondary outcomes (4)
Length of stay
Length of stay between experimental and placebo groups
Measured: During hospital stay: up to two weeks
Number of urinary catheterizations
Number of bladder catheterization
Measured: During hospital stay: up to two weeks
Number of urine catheter reinsertions
Number of urine catheter reinsertions
Measured: During hospital stay: up to two weeks
Total duration of urinary catheter being in-situ
Number of days a foley catheter will be in place
Measured: During hospital stay: up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start10 Nov 2023
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- 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
- Model description
- Our study will be a phase III double-blind randomized clinical trial. A period of 12 to 24 months is planned for recruitment. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication. The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération des médecins résidents du Québec
- Responsible party
- Sponsor
- Investigators
- Frédérique Beauchamp, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941806
- Sponsor's protocol ID
- Projet 2023-6826
- Acronym
- R-POUR
- Status last verified
- Sep 2026
- First submitted
- 12 May 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection: a Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05941806
- Acronym / sponsor ID
- R-POUR / Projet 2023-6826
- Conditions
- Urinary Retention, Colorectal Surgery, Rectal Resection, Post-operative Urinary Retention, Tamsulosin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Fédération des médecins résidents du Québec
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 12 Jul 2023 (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 study will be a phase III double-blind randomized clinical trial. Participants will be recruited from the Department of General Surgery of the CHU de Québec - Saint-François-d'Assise and Hôtel-Dieu de Québec. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication.The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.
Detailed description
Participants will be recruited consecutively during their preoperative visit to the outpatient clinic. Participants will be followed by a logbook throughout the follow-up period, as well as by their surgical and research teams. Follow-up will begin on the first day of pre-operative medication and will end 30 days after surgery. Patients randomized to the intervention group will receive 0.4 mg tamsulosin capsules, administered orally, once a day for 5 days before surgery, the morning of surgery and the day after surgery. Patients assigned to the placebo group will receive glucose capsules according to the same protocol. The glucose capsules will be manufactured by the pharmacy of the CHU de Quebec. All patients will have a foley catheter inserted for surgery. Their urinary catheter (foley catheter) will be removed at 6:00 AM the day after their surgery (post-operative day 1). The diagnosis of urinary retention will be suspected by a member of the patient's medical team if a patient has no miction for 8 hours or more or 4 hours or more after removal of foley catheter or after the surgery. In these cases, a portable bladder scanner will be used. The diagnosis of post-operative urinary retention (POUR) will be confirmed in two situations: 1. If there is 500ml of urine or more in the bladder 2. If there is 300ml or urine or more with at least 1 of the following symptoms: urge to urinate with inability to urinate, suprapubic pain or signs and symptoms of delirium. When the diagnosis of POUR will be made, urine will be removed from the bladder using an in/out bladder catheterization. After using a bladder catheterization, a portable bladder scanner will be used again if a patient has no spontaneous urination for the first 4 hours after catheterization. A second bladder catheterization will be done once again in the same two situations as described above. At the third bladder catheterization, a urinary (foley) catheter will be inserted. The catheter will be left in place for 24h before attempting a trial of void. A member of the medical team will then collect the information in the patient's logbook and medical record. Adherence to drug intake will be self-reported to the patient's diary. The patient can indicate why he missed one or more doses of the drug. Patients will receive a list of potential side effects of tamsulosin with their logbook. The side effects will be self-reported by the patient to the logbook each day. The patients' logbook will be analysed by the research team. Two independent reviewers of the research team will collect the other variables. They will perform a standardized retrospective revision of the medical records according to a pre-established data collection grid. We will perform an intention-to-treat analysis in this prospective randomized study. Postoperative urinary retention remains a frequent complication and causes significant discomfort in men undergoing rectal resection. The decrease in its incidence could then significantly reduce the number of bladder catheterizations required postoperatively, and thus reduce the incidence of complications associated with it. The prevention of POUR will allow patients a more harmonious postoperative recovery, limited in inconvenience and side effects, and an earlier return home. Ultimately, the health care costs associated with this postoperative complication may be reduced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Our study will be a phase III double-blind randomized clinical trial. A period of 12 to 24 months is planned for recruitment. The primary outcomes are the incidence of postoperative urinary retention in men undergoing rectal resection and the efficacy of prophylactic tamsulosin to prevent this type of complication. The secondary outcomes are the length of stay between experimental and placebo groups, the number of urinary catheterizations, the number of urine catheter reinsertions and total duration of urinary catheter being in-situ.
| Arm | Type | Receives |
|---|---|---|
| Group receiving Tamsulosin | Active comparator | Drug: pr Sandoz TamsulosinPatients randomized to the intervention group will receive 0.4 mg tamsulosin capsules, administered orally, once a day for 5 days before surgery, the morning of surgery and the day after surgery. The steady-state plasma concentration of tamsulosin is reached after 4 to 5 consecutive doses, which justify the administration duration of 5 days preoperatively. The total duration of administration of tamsulosin was established at 7 days since the study of Patel et al. showed a significant reduction in POUR after 7 days of administration. |
| Group receiving Placebo | Placebo comparator | Drug: GlucosePatients assigned to the placebo group will receive glucose capsules according to the same protocol. The glucose capsules will be manufactured by the pharmacy of the CHU de Quebec. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients
- 18 years and older
- Scheduled for rectal resection during the study period.
Key exclusion criteria (8 listed)
- Patients undergoing revisional surgery
- Patients taking alpha-blocker medication,
- Patients who have an indwelling urinary catheter,
- Patients who have undergone urinary tract surgery,
- Patients who will have an intraoperative trauma of the urinary tract,
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 |
|---|---|---|
| pr Sandoz TamsulosinAlso: Tamsulosin hydrochlorideSandoz Tamsulosin, the study drug, is an alpha1-adrenergic blocking agent approved by Health Canada for men with bladder outlet obstruction symptoms associated with benign prostatic hyperplasia. | Drug | Group receiving Tamsulosin |
| GlucosePatients assigned to the placebo group will receive glucose capsules according to the same protocol. The glucose capsules will be manufactured by the pharmacy of the CHU de Quebec | Drug | Group receiving Placebo |
Primary outcome
Postoperative urinary retention
Time frame: During the length of hospital stay: up to two weeks
Incidence of postoperative urinary retention in men undergoing rectal resection
4 secondary outcomes
Length of stay
Time frame: During hospital stay: up to two weeks
Number of urinary catheterizations
Time frame: During hospital stay: up to two weeks
Number of urine catheter reinsertions
Time frame: During hospital stay: up to two weeks
Total duration of urinary catheter being in-situ
Time frame: During hospital stay: up to two weeks
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 10 Sep 2026.
- 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.
Frédérique Beauchamp, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pr Sandoz Tamsulosin and Glucose in people with Urinary Retention and Colorectal Surgery, run by CHU de Quebec-Universite Laval 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 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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 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?
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 Frédérique Beauchamp, MD (4182717881, frederique.beauchamp.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative urinary retention (time frame: During the length of hospital stay: up to two weeks). 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 10 Sep 2026.