Tamsulosin for Postoperative Urinary Retention

Recruiting at 3 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

Trial Summary

What is the purpose of this trial?

This is a feasibility study looking at whether the use of Tamsulosin could lower the high incidence of postoperative urinary retention (POUR) in older men who undergo an oncological thoracic surgical procedure for suspected or confirmed cancer. In addition, the study will try to identify the time of resumption of presurgical urinary function post Tamsulosin administration.

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.

What data supports the effectiveness of the drug Tamsulosin for preventing postoperative urinary retention?

Research shows that Tamsulosin, an alpha blocker, helps relax bladder neck muscles, reducing the risk of urinary retention after surgeries. Studies have found it effective in preventing urinary retention in both men and women after various types of surgeries, including pelvic and urologic procedures. ^{1 2 3 4 5}

Is Tamsulosin safe for humans?

Tamsulosin has been studied for various conditions and is generally considered safe for humans. 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. ^{2 3 4 5 6}

How does the drug tamsulosin differ from other treatments for postoperative urinary retention?

Tamsulosin is unique because it is a selective alpha blocker that specifically targets alpha-1A and alpha-1B-adrenoceptors, which helps relax the muscles in the bladder neck and reduce bladder outlet resistance. This makes it effective in preventing postoperative urinary retention, especially when used preemptively, unlike other treatments that may not specifically target these receptors. ^{1 2 7 8 9}

Research Team

Thomas L. Bauer

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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 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 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 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]

References

1. 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]

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

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

3. Brazil 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. [2018]

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

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

5. 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]

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

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

8. 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]

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

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