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
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.
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.
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 →CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
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
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
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
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
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
Length of stay
Length of stay between experimental and placebo groups
Time frame: During hospital stay: up to two weeks
Number of urinary catheterizations
Number of bladder catheterization
Time frame: During hospital stay: up to two weeks
Number of urine catheter reinsertions
Number of urine catheter reinsertions
Time frame: 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
Time frame: During hospital stay: up to two weeks
Plan to share: No
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Studies of the drug tested here: Tamsulosin
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