Prophylactic Tamsulosin for Urinary Retention After Colorectal Surgery

(R-POUR Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tamsulosin, a medication, can prevent urinary retention (difficulty urinating) in men after colorectal surgery. The goal is to determine if taking this medication before and after surgery reduces catheter use and shortens hospital stays. Men scheduled for rectal surgery who do not take certain medications or have specific urinary conditions may qualify for this study. Participants will receive either tamsulosin or a placebo (a pill with no active medicine) to compare outcomes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that tamsulosin is generally safe for people undergoing surgery. One study found that tamsulosin effectively prevents urinary retention (difficulty peeing) in both men and women. Many previous studies have demonstrated the safety of the 0.4 mg dose used in this trial. Additionally, a review of multiple studies found that taking tamsulosin before surgery can reduce the risk of urinary problems by 39%.

These findings suggest that tamsulosin is safe for preventing urinary retention after surgery, with few side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Tamsulosin for preventing urinary retention after colorectal surgery because it offers a unique approach compared to current options. Most treatments for urinary retention focus on relieving symptoms after they occur, often through catheterization. Tamsulosin works differently by relaxing the muscles in the prostate and bladder neck, potentially preventing retention before it even starts. This proactive approach could improve patient comfort and recovery times significantly, making it an appealing option for post-surgery care.

What evidence suggests that tamsulosin might be an effective treatment for preventing urinary retention after colorectal surgery?

Research has shown that tamsulosin, which participants in this trial may receive, can help lower the risk of urination difficulties after colorectal surgery. One study found that this medication reduced the rate of urinary problems from 25% in a group not taking it to significantly lower numbers. Another review demonstrated a 39% lower risk of urinary issues with tamsulosin. In some cases, urinary problems decreased by up to 88% with various tamsulosin treatments. Overall, these findings suggest that tamsulosin effectively reduces the chances of urinary problems after surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Frédérique Beauchamp, MD

Principal Investigator

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34647159/

Prophylactic tamsulosin and urinary retention rates ... Prophylactic tamsulosin reduced POUR after colorectal surgery with the greatest effect in men 60 years or older and colonic resections.

2. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/january-7-2025-issue/tamsulosin-with-eras-protocols-reduces-rates-of-urinary-retention-after-colorectal-surgery/

Tamsulosin with ERAS Protocols Reduces Rates of Urinary ... Urinary retention was documented in 9.2% of the control group compared to 4.7% of the treatment group. The authors concluded that use of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05753670

Effect of Preoperative Tamsulosin on Postoperative Urinary ... Previous studies have demonstrated a postoperative urinary retention rate decrease of 65-88% after various tamsulosin protocols. However, the effect of single ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9684334/

Prophylactic tamsulosin can reduce the risk of urinary ... Our present systematic review and meta-analysis found that prophylactic tamsulosin was related to a 39% reduction in risk of POUR among various operation ...

5. withpower.com withpower.com/trial/phase-3-urinary-retention-7-2023-2c526

Prophylactic Tamsulosin for Urinary Retention After ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11661766/

Evaluating the Safety of Empiric Tamsulosin to Prevent ... The purpose of this study was to evaluate the safety of empiric tamsulosin in male veterans undergoing major colorectal surgery.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405857223001286

Preoperative tamsulosin effect on postoperative urinary ... Tamsulosin may be effective in preventing postoperative urinary retention (POUR), but its effectiveness in treating established POUR is uncertain.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06257576

NCT06257576 | Function of Tamsulosin in Older Males ... The 0.4 mg dose of tamsulosin that will be used in this trial has shown adequate safety and tolerability in multiple previously published studies as well as ...