Prophylactic Tamsulosin for Urinary Retention After Colorectal Surgery

(R-POUR Trial)

Recruiting at 1 trial location

Overseen By Sébastien Drolet, MD FRCSC

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Alpha-blockers, Antiretrovirals, Antifungals, others

Disqualifiers: Revisional surgery, Urinary catheter, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

220 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

If you are taking alpha-blocker medication or any of the listed drugs with potential interactions, you cannot participate in the trial. The protocol does not specify if you need to stop other medications, but it seems likely that you may need to stop taking those specific drugs.

What data supports the effectiveness of the drug Tamsulosin for preventing urinary retention after colorectal surgery?

Research shows that Tamsulosin, an alpha blocker that relaxes bladder neck muscles, can significantly reduce urinary retention rates after surgeries, including colorectal and pelvic surgeries. A systematic review and meta-analysis found that prophylactic use of Tamsulosin effectively lowers the risk of urinary retention in male patients after surgery. ^{1 2 3 4 5}

Is tamsulosin generally safe for humans?

Tamsulosin has been studied for various conditions and is generally considered safe for humans. An 8-year study found it to be a safe and effective treatment for reducing the risk of acute urinary retention in patients with prostatic adenoma, with a low incidence of side effects. ^{1 2 5 6 7}

How does the drug tamsulosin differ from other treatments for preventing urinary retention after colorectal surgery?

Tamsulosin is unique because it is an alpha blocker that relaxes the muscles in the bladder neck, which helps prevent urinary retention after surgery. Unlike other treatments, it is used preemptively to reduce the risk of urinary retention, which can lead to fewer complications like urinary tract infections and shorter hospital stays. ^{1 2 3 8 9}

Research Team

Frédérique Beauchamp, MD

Principal Investigator

Eligibility Criteria

This trial is for male patients aged 18 or older who are scheduled for rectal resection. It's not open to those with urinary tract trauma, epidural anesthesia during surgery, revisional surgeries, past urinary tract surgeries, current alpha-blocker medication use, indwelling catheters post-surgery over 24 hours, or intolerance to alpha-blockers.

Inclusion Criteria

I am scheduled for surgery to remove part of my rectum.

I am a man aged 18 or older.

Exclusion Criteria

You are not expected to have a urinary catheter for more than 24 hours after surgery.

You have a tube in your bladder to help you pee.

I will have surgery that involves my urinary system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-operative Treatment

Participants receive 0.4 mg tamsulosin or placebo capsules once a day for 5 days before surgery

1 week

Daily self-administration

Surgery and Immediate Post-operative Care

Participants undergo rectal resection surgery and immediate post-operative care including foley catheter management

1-2 weeks

Inpatient hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of postoperative urinary retention

4 weeks

Logbook and medical record review

Treatment Details

Interventions

• Tamsulosin

Trial Overview The study tests if Tamsulosin can prevent urinary retention after rectum resection in men. It's a phase III trial where participants are randomly given either Tamsulosin or a placebo without knowing which one they receive (double-blind). Hospital stay length and number of catheterizations will also be compared.

Participant Groups

Group I: Group receiving Tamsulosin Active Control 1 Intervention

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.

Group II: Group receiving Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Fédération des médecins résidents du Québec

Collaborator

Trials

2

Recruited

270+

Findings from Research

A study of 185 men undergoing pelvic surgery found that preemptive use of tamsulosin significantly reduced urinary retention rates from 25% in the control group to 6.7% in the tamsulosin group, indicating its efficacy in preventing this complication.

The research suggests that using tamsulosin before and after surgery can be particularly beneficial for patients with distal rectal cancer, as it was identified as a strong predictor of urinary retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. Poylin, V., Curran, T., Cataldo, T., et al.[2018]

In a study of 157 male patients over 50 undergoing elective colorectal surgery, early catheter removal on postoperative day 2 was associated with a decreased urinary tract infection (UTI) rate of 5.13%.

Urinary retention (UR) occurred in 11.46% of patients, which is consistent with existing literature, and was significantly linked to postoperative ileus, while the use of tamsulosin did not show an effect on UR in this cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary retention in early urinary catheter removal after colorectal surgery. Ghuman, A., Kasteel, N., Karimuddin, AA., et al.[2019]

In an 8-year study involving 665 men with stage I prostatic adenoma, those treated with tamsulosin (Omnic) had a significantly lower incidence of acute urinary retention (6.45%) compared to those using herbal preparations (36.2%).

Tamsulosin not only reduced the risk of acute urinary retention by 5.6 times but also decreased the need for surgical intervention from 27.8% to 6.3%, demonstrating its safety and efficacy as a long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[INCIDENCE OF ACUTE URINARY RETENTION IN PATIENTS WITH PROSTATIC ADENOMA AND 8-YEAR LONG TAMSULOSIN THERAPY]. Davidov, MI., Lokshin, KL., Gorbunova, IS.[2018]

In a study involving 116 men who underwent transurethral resection of the prostate (TURP), the addition of tamsulosin hydrochloride (TAM) or a combination of TAM and solifenacin succinate (SOL) did not significantly improve overall lower urinary tract symptoms compared to TURP alone during the early recovery period.

While there were some minor improvements in specific scores (like the IPSS storage and voiding scores) for the groups receiving TAM and SOL, these changes were not substantial enough to indicate a clear benefit over TURP alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tamsulosin hydrochloride 0.2 mg and combination of tamsulosin hydrochloride 0.2 mg plus solifenacin succinate 5 mg after transurethral resection of the prostate: a prospective, randomized controlled trial. Shin, YS., Zhang, LT., You, JH., et al.[2018]

In a study of 90 men with acute urinary retention due to benign prostatic hyperplasia, tamsulosin showed a slightly higher success rate in catheter removal (43.2%) compared to alfuzosin (35.2%) and placebo (26.3%), although these differences were not statistically significant.

Both tamsulosin and alfuzosin were found to be equally effective in facilitating successful trial without catheter (TWOC), suggesting that the choice between these two medications may not significantly impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study on the use of tamsulosin versus alfuzosin in spontaneous micturition recovery after transurethral catheter removal in patients with benign prostatic growth. Maldonado-Ávila, M., Manzanilla-García, HA., Sierra-Ramírez, JA., et al.[2021]

In a randomized, double-blind trial involving 130 patients undergoing colporrhaphy, prophylactic tamsulosin significantly reduced the incidence of acute urinary retention and decreased post-void residual (PVR) urine volume compared to a placebo.

Tamsulosin also improved urine flow diameter, indicating its efficacy in alleviating obstructive urinary symptoms following surgery, although not all urinary symptoms showed significant differences between the treatment and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery. Shokrpour, M., Shakiba, E., Sirous, A., et al.[2022]

In a study involving 158 adults undergoing elective abdominal surgery, preoperative administration of tamsulosin did not significantly reduce the incidence of postoperative urinary retention (POUR) compared to a placebo, with rates of 26% in the tamsulosin group versus 31% in the placebo group.

Secondary outcomes, including the need for catheterization and urinary tract infections, also showed no significant differences between the tamsulosin and placebo groups, indicating that tamsulosin is not effective for preventing POUR in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention: A Randomized Controlled Trial. Papageorge, CM., Howington, B., Leverson, G., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Prophylactic tamsulosin and urinary retention rates following elective colorectal surgery: a retrospective cohort study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Urinary retention in early urinary catheter removal after colorectal surgery. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Prophylactic tamsulosin can reduce the risk of urinary retention after surgery in male patients: A systematic review and meta-analysis. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[INCIDENCE OF ACUTE URINARY RETENTION IN PATIENTS WITH PROSTATIC ADENOMA AND 8-YEAR LONG TAMSULOSIN THERAPY]. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tamsulosin hydrochloride 0.2 mg and combination of tamsulosin hydrochloride 0.2 mg plus solifenacin succinate 5 mg after transurethral resection of the prostate: a prospective, randomized controlled trial. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A comparative study on the use of tamsulosin versus alfuzosin in spontaneous micturition recovery after transurethral catheter removal in patients with benign prostatic growth. [2021]

8. India pubmed.ncbi.nlm.nih.gov

Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention: A Randomized Controlled Trial. [2021]