Preoperative Tamsulosin for Urinary Retention After Thoracic Surgery

(POUR Trial)

Recruiting at 1 trial location

Overseen By Daniel Mansour, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Hackensack Meridian Health

Must be taking: Flomax

Must not be taking: Alpha blockers, Alpha agonists

Disqualifiers: Congestive heart failure, Valvular heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

127 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking Tamsulosin, a medication that aids urination, before chest surgery can prevent post-surgery urination problems. Such issues often occur after surgery and can cause discomfort and longer hospital stays. The trial examines two timing options for starting the medication: one week or three days before surgery. Men aged 50 or older planning certain chest surgeries may qualify if they aren't already using Tamsulosin or similar medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial requires that you stop taking Flomax and any alpha blockers or alpha agonists before participating.

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

Research has shown that tamsulosin is generally a safe option for treating urinary retention. The FDA has approved it to improve urine flow in individuals with enlarged prostates. Studies have found that using tamsulosin preventatively can reduce the risk of urinary retention after surgery by 39%. Specifically, one study showed a 65% decrease in urinary retention when tamsulosin was taken for 10 days, including 3 days before surgery. Tamsulosin is well-tolerated, with few reports of side effects, making it a reliable choice for preventing urinary problems after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Tamsulosin preoperatively to prevent urinary retention after thoracic surgery because it offers a targeted approach by relaxing muscles in the urinary tract, which can help reduce post-surgery complications. Unlike standard treatments that manage symptoms after they appear, Tamsulosin's proactive use may prevent the issue from arising in the first place. This approach could lead to quicker recovery times and fewer hospital resources used in managing urinary retention, making it a promising option compared to reactive treatments.

What evidence suggests that Tamsulosin might be an effective treatment for urinary retention after thoracic surgery?

Research has shown that tamsulosin can help reduce urination problems after surgery. In this trial, participants will receive either a 1-week or a 3-day pre-operative administration of tamsulosin. One study found that taking tamsulosin before surgery lowered the need for a catheter, a tube used to drain urine. Another study discovered that tamsulosin reduced the chance of urinary retention by 65-88%. Additionally, tamsulosin lowered urinary retention rates by about 39% in various surgeries. Overall, these findings suggest that tamsulosin may help prevent urination issues after surgery, especially for men over 60. ^{2 5 6 7 8}

Who Is on the Research Team?

Daniel Mansour, MD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for men over 50 who are scheduled for minimally invasive chest surgery (like lung tissue removal or pleural biopsy) in at least 3 days. It's not for those already on Flomax, with allergies to it or sulfa drugs, using certain blood pressure medications, having very low blood pressure, severe heart conditions, or a history of prostate surgery.

Inclusion Criteria

I am 50 or older and scheduled for a minor chest surgery.

I am male.

My surgery is scheduled for more than 3 days after I give consent.

Exclusion Criteria

I am allergic to Flomax or sulfa drugs.

Your blood pressure when you're not moving around is less than 100.

I have had surgery on my prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive Tamsulosin (Flomax) 0.4mg/day for 1 week before surgery

1 week

Post-operative Treatment

Participants continue Tamsulosin (Flomax) until normal voiding resumes post-surgery

Variable, until normal voiding resumes

Follow-up

Participants are monitored for urinary retention and other complications after surgery

8 hours

What Are the Treatments Tested in This Trial?

Interventions

• Tamsulosin

Trial Overview The study tests if taking Tamsulosin (Flomax), which relaxes the prostate and improves urine flow, can prevent urinary retention when started either one week before or three days prior to thoracic surgery. The goal is to reduce complications like catheter-related issues.

How Is the Trial Designed?

Group I: 3 days Pre-operative Tamsulosin administration Experimental Treatment 1 Intervention

Group II: 1 week Pre-operative Tamsulosin administration Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Published Research Related to This Trial

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]

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 236 patients undergoing robot-assisted laparoscopic radical prostatectomy, tamsulosin treatment significantly reduced the rate of acute urinary retention after early catheter removal, with a rate of 7.3% compared to 17.4% in the control group.

Tamsulosin treatment was associated with a 0.30-fold lower risk of developing acute urinary retention, indicating its efficacy in preventing this complication without worsening urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tamsulosin on urinary retention following early catheter removal after robot-assisted laparoscopic radical prostatectomy: a prospective randomized controlled trial. Jeong, IG., You, D., Yoon, JH., et al.[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 clinical trial involving 610 male patients aged 50 to 85 undergoing elective spine surgery, preoperative administration of tamsulosin did not significantly reduce the rate of postoperative urinary retention compared to a placebo (9.4% vs 9.9%).

The study found no significant differences in adverse events between the tamsulosin and placebo groups, indicating that tamsulosin may not be effective for this purpose and does not support its routine use in preventing urinary retention after spine surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does tamsulosin decrease postoperative urinary retention in spine surgery? A double-blind, randomized controlled trial. Rughani, A., Cushing, D., Lary, CW., et al.[2022]

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]

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 involving 425 cystograms, tamsulosin significantly reduced the incidence of acute urinary retention from 10% to 2.6% after early catheter removal following radical retropubic prostatectomy.

The results indicate that administering tamsulosin for 7 days around the time of catheter removal can improve outcomes, as shown by a higher percentage of patients with no extravasation (93.5% in the tamsulosin group compared to 75% in the control group).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tamsulosin reduces the incidence of acute urinary retention following early removal of the urinary catheter after radical retropubic prostatectomy. Patel, R., Fiske, J., Lepor, H.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24642148/

Effectiveness of tamsulosin in prevention of post-operative ... This study suggests that short perioperative treatment with tamsulosin can reduce the incidence of urinary retention and the need for catheterization.

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2287888222000782

Comparing effects of alpha-blocker management on acute ... Alpha blockers may increase the success rate of TWOC. This study evaluated the priority of the effect of several alpha-blocker regimens on AUR related to BPH.

4. 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 ...

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.930707/full

Prophylactic tamsulosin can reduce the risk of urinary ... The results showed that prophylactic tamsulosin could reduce the risk of POUR by a statistically significant 39% in a range of surgical procedures. The ...

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12182465/

Effect of Preoperative Tamsulosin on Postoperative Urinary ... These results suggest that single-dose preoperative tamsulosin might not have an effect on postoperative urinary retention after MUS placement.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04232683

Preoperative Tamsulosin to Prevent Postoperative Urinary ... Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females ...