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

NCT05941806 | Unknown Phase 3 FDA Drug

• 1 other identifier: Projet 2023-6826
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postoperative urinary retention

  Incidence of postoperative urinary retention in men undergoing rectal resection

  During the length of hospital stay: up to two weeks

Secondary Outcomes (4)

• Length of stay

  During hospital stay: up to two weeks

• Number of urinary catheterizations

  During hospital stay: up to two weeks

• Number of urine catheter reinsertions

  During hospital stay: up to two weeks

• Total duration of urinary catheter being in-situ

  During hospital stay: up to two weeks

Study Arms (2)

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.

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.

Drug: Glucose

Interventions

pr Sandoz Tamsulosin DRUG

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

Group receiving Tamsulosin

Glucose DRUG

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

Group receiving Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Fédération des médecins résidents du Québec: collaborator

Study Sites (2)

Hotel Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Hôpital Saint-François d'Assise

Québec, G1L 3L5, Canada

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

Tamsulosin; Glucose

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Frédérique Beauchamp, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédérique Beauchamp, MD

CONTACT

4182717881; frederique.beauchamp.1@ulaval.ca

Sébastien Drolet, MD FRCSC

CONTACT

4184550900; sebastien.drolet.chx@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: July 12, 2023
• Study Start: August 1, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)