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

Trial Summary

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.

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

Research shows that Tamsulosin, a drug that relaxes bladder muscles, effectively reduces urinary retention after surgeries like prostate and pelvic surgeries. This suggests it might also help prevent urinary retention after thoracic surgery. ^{1 2 3 4 5}

Is tamsulosin safe for use in humans?

Tamsulosin has been studied for various conditions and is generally considered safe for human use. An 8-year study showed that it effectively reduced the risk of acute urinary retention with a low incidence of side effects, making it a safe option for long-term use. ^{3 4 6 7 8}

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

Tamsulosin is unique because it is an alpha blocker that specifically targets and relaxes the muscles in the bladder neck, which helps reduce bladder outlet resistance and prevent urinary retention. Unlike other treatments, it is used preoperatively to prevent urinary retention, a common issue after surgeries, by addressing the problem before it occurs. ^{1 3 5 8 9}

What is the purpose of this trial?

Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.

Research Team

Daniel Mansour, MD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

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]

References

1. Australia 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. [2018]

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

Tamsulosin reduces the incidence of acute urinary retention following early removal of the urinary catheter after radical retropubic prostatectomy. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. 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]

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

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

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

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

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

Does tamsulosin decrease postoperative urinary retention in spine surgery? A double-blind, randomized controlled trial. [2022]