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RecruitingNCT05941806R-POURUpdated Sep 10, 2026

Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection

A Phase 3 interventional study of pr Sandoz Tamsulosin and Glucose in Urinary Retention, Colorectal Surgery and Rectal Resection, sponsored by CHU de Quebec-Universite Laval. Recruiting at 1 site in Canada. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by CHU de Quebec-Universite Laval · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Urinary Retention
  • Colorectal Surgery
  • Rectal Resection
  • Post-operative Urinary Retention
  • Tamsulosin

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03

In context

Urinary Retention

241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.

This study's planned enrollment of 220 is above the median of 90 across 187 interventional studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male patients
  • 18 years and older
  • Scheduled for rectal resection during the study period.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
220 participants (estimated)

Study arms

  • Active comparator
    Group receiving Tamsulosin

    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.

    Drug: pr Sandoz Tamsulosin

  • Placebo comparator
    Group receiving Placebo

    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.

    Drug: Glucose

Interventions

  • 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.

    Also known as: Tamsulosin hydrochloride

  • DrugGlucose

    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

06

What researchers measure

Primary outcomes

  1. Postoperative urinary retention

    Incidence of postoperative urinary retention in men undergoing rectal resection

    Time frame: During the length of hospital stay: up to two weeks

Secondary outcomes

  1. Length of stay

    Length of stay between experimental and placebo groups

    Time frame: During hospital stay: up to two weeks

  2. Number of urinary catheterizations

    Number of bladder catheterization

    Time frame: During hospital stay: up to two weeks

  3. Number of urine catheter reinsertions

    Number of urine catheter reinsertions

    Time frame: During hospital stay: up to two weeks

  4. Total duration of urinary catheter being in-situ

    Number of days a foley catheter will be in place

    Time frame: During hospital stay: up to two weeks

07

Study locations

1 of 1 sites recruiting
  • Hôpital Saint-François d'Assise
    Québec, Quebec G1L 3L5, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05941806
Collaborators
Fédération des médecins résidents du Québec
Responsible party
Sponsor
First posted
Jul 12, 2023
Start date
Nov 10, 2023
Primary completion
Jul 30, 2027 (estimated)
Completion
Jul 30, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Frédérique Beauchamp, MD
Contact
frederique.beauchamp.1@ulaval.ca
4182717881
Sébastien Drolet, MD FRCSC
Contact
sebastien.drolet.chx@gmail.com
4184550900
Frédérique Beauchamp, MD
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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