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

Trial Summary

What is the purpose of this trial?

The objectives of this study are to determine the feasibility of conducting a full-scale randomized control trial comparing the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention in people undergoing elective thoracic surgery.

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.

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

Research shows that Tamsulosin significantly reduces the risk of acute urinary retention in patients with prostatic adenoma, with an 8-year study indicating a 5.6 times lower risk compared to herbal treatments. Additionally, it improves urinary symptoms and flow rates in patients with bladder outlet obstruction due to benign prostatic hyperplasia. ^{1 2 3 4 5}

Is Tamsulosin generally safe for humans?

There is no specific safety data for Tamsulosin in the provided research articles. ^{6 7 8 9 10}

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

Tamsulosin is unique because it significantly reduces the risk of acute urinary retention compared to herbal treatments, decreasing the need for surgery. It is a prescription drug that works by relaxing muscles in the prostate and bladder, making it easier to urinate. ^{1 3 11 12 13}

Research Team

Rahul Nayal

Principal Investigator

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

Eligibility Criteria

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

I am currently being treated for an enlarged prostate.

Hypersensitivity or allergy to tamsulosin HCL

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

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 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 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]

References

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

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

2. Japan 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]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder. [2021]

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

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

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

[Experience in long term use of tamsulosin (Omnik) in patients with chronic prostatitis]. [2018]

6. Poland pubmed.ncbi.nlm.nih.gov

Gastrointestinal tract as a side-effect target of medications. [2018]

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

Re-evaluation of the Cardiovascular Safety Profile of Tegaserod: A Review of the Clinical Data. [2022]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Systematic review: short-term adverse effects of 5-aminosalicylic acid agents in the treatment of ulcerative colitis. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Gastrointestinal and liver side effects of drugs in elderly patients. [2016]

11. 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]

12. Poland 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. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia. [2022]