Tamsulosin for Urinary Retention

(PrePOURTS Trial)

Overseen By Deb Lewis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lawson Health Research Institute

Must not be taking: Alpha-blockers, CYP3A4 inhibitors

Disqualifiers: BPH, Urological disorders, Neurological, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called tamsulosin to determine if it can reduce urinary retention (trouble peeing) after chest surgery. The goal is to compare the effectiveness of tamsulosin against a placebo (a pill with no medicine) in addressing this issue. Men aged 40 or older with conditions such as diabetes or past urinary problems may be suitable for this study. Participants should not be taking certain medications or have specific medical conditions like active urinary infections or severe kidney issues. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking tamsulosin or other alpha-blockers at least 3 weeks before joining. If you're on certain medications that affect liver enzymes (like ketoconazole or erythromycin), you may not be eligible to participate.

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

Research has shown that tamsulosin is generally safe for treating urinary retention. In one study, patients taking tamsulosin experienced a very low rate of dizziness when standing up, even after six years of use. Another study found that both men and women tolerated tamsulosin well, indicating it can safely help reduce urinary problems.

Tamsulosin has also been studied in various surgeries, such as those involving the abdomen and colon. These studies demonstrated that it effectively lowers the risk of urinary retention after surgery without causing major side effects. Overall, tamsulosin appears to be a well-tolerated treatment with a good safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tamsulosin is unique because it targets urinary retention by relaxing muscles in the bladder and prostate, making it easier to urinate. Unlike some current treatments that may focus on other mechanisms or require invasive procedures, Tamsulosin offers a non-invasive option that is specifically designed to improve urine flow quickly. Researchers are excited about Tamsulosin because it has the potential to provide faster relief with fewer side effects, improving quality of life for those dealing with urinary retention.

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

Research shows that tamsulosin, which participants in this trial may receive, can help reduce urination problems after surgery. One study found that short-term use of tamsulosin lowered the need for a catheter by easing urination difficulties. Another study reported that only 4.7% of patients taking tamsulosin experienced trouble urinating, compared to 9.2% of those who did not. Additionally, some research indicates a 65-88% decrease in urination problems with various tamsulosin treatments. These findings suggest that tamsulosin could significantly alleviate urinary issues after surgery. ^{2 4 6 7 8}

Who Is on the Research Team?

Rahul Nayal

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Are You a Good Fit for This Trial?

This trial is for men aged 40 or older who have had urinary retention before, a prostate symptom score of at least 1, diabetes, and are using thoracic epidural analgesia. They can't join if they're allergic to tamsulosin, recently took alpha-blockers, have a UTI or BPH being treated, neurological bladder issues, past urological surgery or disorders like strictures or cancer.

Inclusion Criteria

International Prostate Specific Score greater than or equal to 1

I am male.

I am using a thoracic epidural for pain management.

Exclusion Criteria

Hypersensitivity or allergy to tamsulosin HCL

I am currently being treated for an enlarged prostate.

I am currently taking or have taken an alpha-blocker like tamsulosin within the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tamsulosin or placebo to assess efficacy in reducing post-operative urinary retention

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and catheter-related outcomes

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Tamsulosin Hydrochloride

Trial Overview

The study tests whether Tamsulosin Hydrochloride can prevent urinary retention after lung surgery compared to a placebo. Participants will be randomly assigned to receive either the medication or an inactive substance.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Tamsulosin

Group II: Placebo Placebo Group 1 Intervention

Placebo

Tamsulosin Hydrochloride is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Flomax for:

• Benign prostatic hyperplasia (BPH)

Approved in European Union as Omnic for:

• Benign prostatic hyperplasia (BPH)

Approved in Canada as Tamsulosin Hydrochloride for:

• Benign prostatic hyperplasia (BPH)

Approved in Japan as Tamsulosin Hydrochloride for:

• Benign prostatic hyperplasia (BPH)

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Published Research Related to This Trial

Several medications, including sulfasalazine and various mesalamine formulations, are effective first-line treatments for mildly to moderately active ulcerative colitis and help maintain remission.

Higher doses of these medications do not show increased efficacy beyond 1.5 g, and sulfasalazine is associated with more side effects compared to other options, making once-daily dosing of mesalamine a preferable choice for better patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of ulcerative colitis with oral mesalamine: advances in drug formulation, efficacy expectations and dose response, compliance, and chemoprevention. Sandborn, WJ.[2013]

A population pharmacokinetic model for tamsulosin hydrochloride (HCl) was developed in 189 pediatric patients aged 2-16 years, showing that body weight and alpha(1)-acid glycoprotein significantly influence the drug's clearance and distribution.

The study found no major differences in the pharmacokinetics of tamsulosin HCl between pediatric patients and adults when adjusted for body weight, indicating that weight-based dosing can achieve similar drug exposure levels in children as seen in healthy adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder. Tsuda, Y., Tatami, S., Yamamura, N., et al.[2021]

In a study of 160 patients with acute urinary retention due to benign prostatic hyperplasia, both tamsulosin and silodosin were found to be similarly effective for trial without catheter, with success rates of 67.5% and 60%, respectively.

While tamsulosin showed a slightly higher efficacy for trial without catheter, there were no significant differences in patient outcomes measured by the international prostate symptom score (IPSS), post void residual volume (PVR), and peak flow rate (PFR) between the two medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of tamsulosin and silodosin in the management of acute urinary retention secondary to benign prostatic hyperplasia in patients planned for trial without catheter. A prospective randomized study. Patil, SB., Ranka, K., Kundargi, VS., 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]

In two large phase III trials involving men with benign prostatic hyperplasia, tamsulosin (0.4 and 0.8 mg daily) showed significant improvements in urinary symptoms and flow rates compared to placebo over 13 weeks.

Tamsulosin was well tolerated with minimal side effects, showing no significant changes in blood pressure or other health indicators, indicating its safety and rapid onset of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two phase III multicenter, placebo-controlled studies of tamsulosin in BPH. Narayan, P., Bruskewitz, R.[2019]

Tegaserod, a medication for irritable bowel syndrome with constipation, has been found to be safe for women under 65 years old who do not have a history of cardiovascular ischemic events and have one or fewer cardiovascular risk factors, based on evaluations of 18,645 patients.

In two independent external reviews, only a small percentage of patients on tegaserod experienced cardiovascular events, and those who did had multiple risk factors, indicating that the drug does not pose significant cardiovascular risks in the appropriate patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-evaluation of the Cardiovascular Safety Profile of Tegaserod: A Review of the Clinical Data. Lacy, BE., Brenner, DM., Chey, WD.[2022]

In a review of 46 randomized trials, mesalazine, olsalazine, and balsalazide were all found to be safe in the short term for treating ulcerative colitis, with no significant increase in adverse events compared to placebo.

Mesalazine and balsalazide showed significantly fewer adverse events and withdrawals compared to sulfasalazine, indicating they may be better tolerated options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: short-term adverse effects of 5-aminosalicylic acid agents in the treatment of ulcerative colitis. Loftus, EV., Kane, SV., Bjorkman, D.[2022]

Elderly individuals (over 60 years) are at a significantly higher risk for adverse drug reactions, particularly gastrointestinal and hepatic issues, due to multi-morbidity and poly-pharmacy, with reactions being at least twice as common compared to younger adults.

Common medications like NSAIDs and antibiotics can lead to serious side effects in the elderly, including gastrointestinal injuries and hepatotoxicity, which is four times more prevalent in this age group, highlighting the need for more clinical studies focused on drug safety in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal and liver side effects of drugs in elderly patients. Triantafyllou, K., Vlachogiannakos, J., Ladas, SD.[2016]

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 of 54 patients with bladder outlet obstruction due to benign prostatic hyperplasia, tamsulosin hydrochloride significantly improved symptoms, as shown by a notable reduction in the international prostate symptom score and decreased residual urine volume after 7 weeks of treatment.

Tamsulosin also enhanced urinary flow rates and bladder capacity, with minimal side effects reported, indicating it is a safe and effective option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of tamsulosin hydrochloride on bladder outlet obstruction associated with benign prostatic hyperplasia: effect on urethral pressure profile and cystometrogram]. Murayama, K., Katsumi, T., Tajika, E., et al.[2018]

In a study of 39 patients with chronic prostatitis, tamsulosin, taken at a standard dose of 0.4 mg daily for one year, significantly improved symptoms related to lower urinary tract issues and chronic prostatitis.

Combining tamsulosin with other treatments like antibiotics and anti-inflammatory medications enhanced treatment effectiveness, while tamsulosin alone is effective for micturition disorders in patients without exacerbated symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience in long term use of tamsulosin (Omnik) in patients with chronic prostatitis]. D'iakov, VV., Govorov, AV.[2018]

In a study of 149 men with acute urinary retention (AUR) due to benign prostatic hyperplasia (BPH), those treated with tamsulosin were significantly more likely to successfully void after catheter removal compared to those receiving a placebo (48% vs 26%).

The side effects of tamsulosin were similar to those of the placebo, indicating a favorable safety profile, which supports its use in reducing the need for re-catheterization in men with AUR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia. Lucas, MG., Stephenson, TP., Nargund, V.[2022]

Adverse drug reactions (ADRs) are a significant issue in pharmacotherapy, costing the U.S. healthcare system up to $30.1 billion annually, with about 10% of ADRs affecting the gastrointestinal tract.

Common ADRs include xerostomia in the oral cavity, esophageal irritation from NSAIDs, and drug-induced diarrhea from antibiotics and laxatives, highlighting the importance of physician awareness to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tract as a side-effect target of medications. Domagała-Rodacka, R., Cibor, D., Szczeklik, K., et al.[2018]

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.

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.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002961024006792

Does prophylactic tamsulosin use with ERAS protocol ...

Tamsulosin significantly reduced urinary retention in colorectal surgery (4.7 ​% vs. 9.2 ​%, p ​= ​0.01). · Length of hospital stay was shorter with tamsulosin ( ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC1477608/

Long-Term Efficacy and Safety of Tamsulosin for Benign ...

Of patients completing 6 years of treatment, 80.7% demonstrated consistent positive response with extremely low incidence of orthostasis.

6.

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 ...

7.

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.

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.