Tamsulosin for Postoperative Urinary Retention

Recruiting at 4 trial locations

Overseen By Denise Theiler, RN

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Hackensack Meridian Health

Must not be taking: Tamsulosin, Boceprevir

Disqualifiers: Hypotension, CHF, Prostate surgery, 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: 1

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking Tamsulosin before surgery can reduce urinary problems in older men after chest surgery for cancer. Tamsulosin typically eases urination. The study will also examine how quickly men return to normal urination patterns post-surgery. Eligible participants have scheduled chest surgery for cancer and are not currently taking Tamsulosin. As an Early Phase 1 trial, this research aims to understand Tamsulosin's effects in people, offering participants a chance to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already using Tamsulosin or Boceprevir.

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

Research has shown that tamsulosin is generally safe for individuals undergoing surgery. In a study involving male veterans undergoing major colorectal surgery, tamsulosin proved safe, with most participants not experiencing serious side effects. However, some individuals might experience mild reactions such as dizziness or headaches.

The FDA has also approved tamsulosin for treating an enlarged prostate, indicating it has passed safety tests for that condition. This approval further supports its safety. Overall, these findings suggest tamsulosin is generally safe for preventing urinary retention after surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for postoperative urinary retention typically involve catheterization to help patients urinate after surgery. However, Tamsulosin is unique because it is a medication that can be taken before surgery to prevent this issue from occurring. Researchers are excited about Tamsulosin because it works by relaxing the muscles in the prostate and bladder neck, making it easier to urinate. This preemptive approach could reduce the need for catheterization and improve recovery time, offering a more comfortable and less invasive option for patients undergoing surgery.

What evidence suggests that Tamsulosin might be an effective treatment for postoperative urinary retention?

Research shows that Tamsulosin can help prevent postoperative urinary retention (POUR). In this trial, participants will receive Tamsulosin before surgery. Studies have found that this greatly reduces the risk of POUR and improves urine flow. Specifically, patients who used Tamsulosin experienced a 65-88% drop in POUR rates. The medication works by relaxing the muscles in the bladder and prostate, making urination easier. While this trial focuses on older men undergoing cancer-related surgery, Tamsulosin's benefits for urinary issues have been observed in various types of surgeries. ^{5 6 7 8 9}

Who Is on the Research Team?

Thomas L. Bauer

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for men aged 55 or older who are scheduled to have thoracic cancer surgery and haven't used Tamsulosin before. They shouldn't have low blood pressure, a history of heart failure, valvular heart disease, or previous prostate surgery.

Inclusion Criteria

I am scheduled for a minimally invasive chest cancer surgery.

My surgery is scheduled for more than a week after I give consent.

I am a man aged 55 or older.

Exclusion Criteria

You are allergic to Tamsulosin or sulfa drugs.

I am currently taking Boceprevir.

Your blood pressure drops significantly when you stand up from sitting, as measured after standing for 2 minutes.

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 for 7 days prior to scheduled thoracic oncological surgery

1 week

1 visit (in-person) for prescription and instructions

Post-operative Monitoring

Participants are monitored for postoperative urinary retention (POUR) and undergo bladder scanning

1 day

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tamsulosin

Trial Overview The study tests if Tamsulosin can reduce the high rates of urinary retention after thoracic cancer surgery in older men and how quickly it helps resume normal urinary function post-surgery.

How Is the Trial Designed?

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

Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery for thoracic cancer. Tamsulosin dose is set at 0.4mg/day and should be taken daily for seven days prior to their planned surgery date. Study subjects will also be given a diary to record their daily usage. Study subjects should take Tamsulosin on the day of the surgery with a sip of water.

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Published Research Related to This Trial

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 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 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 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 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 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]

In a study of 180 males undergoing elective urologic surgery under spinal anaesthesia, both tamsulosin and alfuzosin significantly reduced the incidence of postoperative urinary retention (POUR) compared to a placebo, with only 5% and 6.7% of patients needing catheterization, respectively, versus 25% in the placebo group.

The effectiveness of tamsulosin and alfuzosin in preventing POUR was similar, indicating that either medication can be a viable option for reducing urinary retention complications after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. Akkoc, A., Aydin, C., Topaktas, R., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8421999/

Preventive effects of tamsulosin for postoperative urinary ... Tamsulosin administration immediately after lower limb arthroplasty reduced the incidence of urinary retention and diminished the need for long-term ...

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

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

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36445826/

Tamsulosin for prevention of postoperative urinary retention Conclusion: Administration of tamsulosin before and/or after surgery significantly reduced the risk of POUR and improved maximum urinary flow ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02486653

Prevention of Post-operative Urinary Retention (POUR) The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery.

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

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 efficacy ...

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. journals.lww.com journals.lww.com/aosopen/fulltext/2024/12000/evaluating_the_safety_of_empiric_tamsulosin_to.17.aspx

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.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10389420/

Can prophylactic tamsulosin reduce the risk of urinary ... The current meta-analysis suggested that prophylactic tamsulosin contributed to the prevention of postoperative urinary retention. Younger ...