Tamsulosin for Urinary Tract Infections

(FOLI Trial)

Recruiting at 2 trial locations

Overseen By Shishir K. Maithel

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Emory University

Must not be taking: Tamsulosin, PDE5 inhibitors

Disqualifiers: Female, Age <50, Renal impairment, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is being done to answer the question: What is the impact of a medication called tamsulosin (also called Flomax) on the rate of postoperative urinary retention (POUR) and catheter-associated urinary tract infection (UTI)? One of the most common complications following surgery and associated with Foley catheters is post-operative urinary retention (POUR) after the catheter is removed. This is defined as being unable to urinate spontaneously within 8 hours following the removal of the indwelling Foley catheter (the catheter that sits in your bladder to drain urine after surgery). When this happens, it requires intermittent straight catheterization of the bladder (placing a temporary catheter in the bladder to drain the buildup of urine), which can cause a lot of discomfort and anxiety, as well as increase the risk of catheter-associated urinary tract infection (CAUTI).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking daily phosphodiesterase 5 (PDE5) inhibitors, you cannot participate in the trial.

What data supports the effectiveness of the drug Tamsulosin for urinary tract infections?

Research suggests that Tamsulosin, commonly used for prostate issues, may help with urinary tract problems by relaxing muscles in the urinary system, potentially aiding women with recurrent urinary tract infections and dysfunctional voiding. ^{1 2 3 4 5}

Is tamsulosin generally safe for humans?

Tamsulosin, also known as Flomax and other names, has been studied for safety in treating urinary symptoms related to benign prostatic hyperplasia (BPH). Research shows it is generally safe for adults, with studies confirming its safety in managing lower urinary tract symptoms. ^{2 3 5 6 7}

How is the drug Tamsulosin unique for treating urinary tract infections?

Tamsulosin is unique for treating urinary tract infections because it is primarily used to treat lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH), but it is being explored for use in women with recurrent urinary tract infections due to its ability to relax muscles in the urinary tract, potentially improving urine flow and reducing infection risk. ^{3 4 5 8 9}

Research Team

Kenneth Cardona, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for older males who are undergoing surgery and will have a Foley catheter. Participants should not be able to urinate on their own within 8 hours after the catheter is removed. The study excludes those with specific medical conditions or taking certain medications that could interfere with the trial.

Inclusion Criteria

I am scheduled for surgery, which could be for any reason and might involve an open or minimally invasive method.

I am a man and at least 50 years old.

I am considered physically fit for surgery.

Exclusion Criteria

Baseline creatinine >1.5x upper limit of normal

I am under 50 years old.

I am female.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive tamsulosin postoperatively for two days

2 days

Follow-up

Participants are monitored for postoperative urinary retention (POUR) and catheter-associated urinary tract infections (CAUTI)

5 days

Treatment Details

Interventions

• Tamsulosin (Alpha-1 Blocker)

Trial Overview The study tests if tamsulosin (Flomax) can reduce problems like being unable to pee (postoperative urinary retention) and bladder infections linked to catheters, compared to a control group without this medication.

Participant Groups

Group I: Tamusolin Experimental Treatment 1 Intervention

Participants will receive tamsulosin postoperatively for two days.

Group II: Control Group Experimental Treatment 1 Intervention

Participants will be randomized to the standard of care, with no medication given.

Tamsulosin is already approved in Canada, Japan, Switzerland for the following indications:

Approved in Canada as Tamsulosin for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Approved in Japan as Tamsulosin for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Approved in Switzerland as Tamsulosin for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

ABRAHAM J & PHYLLIS KATZ FOUNDATION

Collaborator

Trials

1

Recruited

210+

Findings from Research

In a study of 33 patients with benign prostatic hyperplasia, the combination of tamsulosin and chlormadinone acetate (CMA) showed significant improvement in lower urinary tract symptoms as early as 4 weeks, while tamsulosin alone did not show significant improvement until later.

The combination treatment also significantly increased the average peak urinary flow rate from 10.4 ml/s to 15.6 ml/s, compared to an increase from 8.5 ml/s to 10.5 ml/s with tamsulosin alone, indicating that this combination therapy is effective for both symptom relief and urinary flow improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A randomized long-term comparative study of clinical efficacy of alpha 1-blocker with or without antiandrogen therapy for benign prostatic hyperplasia: focusing on improvement of I-PSS]. Ohtani, M., Kikuchi, K., Tsuchiya, A., 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]

Tamsulosin is primarily used to treat lower urinary tract symptoms caused by benign prostatic hyperplasia, but it is also effective for other genitourinary conditions in both men and women.

As a third-generation selective alpha(1A) adrenoceptor-blocking agent, tamsulosin offers a safer and simpler alternative to traditional surgical treatments for managing urinary symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tamsulosin MR and OCAS (modified release and oral controlled absorption system): current therapeutic uses. Nargund, VH., Grey, AD.[2018]

In a study of 155 women with recurrent urinary tract infections and dysfunctional voiding, the combination of tamsulosin (an α1-adrenoceptor antagonist) and uroflowmetry biofeedback significantly improved urinary symptoms and quality of life over a 12-month follow-up period.

The treatment led to a notable decrease in urinary tract infections and improved urodynamic parameters, such as increased flow rates and decreased post-void residual urine, particularly in patients receiving the combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

α1-Blockers for the treatment of recurrent urinary tract infections in women with dysfunctional voiding: a prospective randomized study. Minardi, D., Pellegrinelli, F., Conti, A., et al.[2018]

Tamsulosin OCAS 0.4 mg effectively improves lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and maintains these benefits over the long term, making it a reliable treatment option.

Tamsulosin OCAS is better tolerated than the traditional tamsulosin MR formulation, with a comparable efficacy profile and a lower risk of cardiovascular side effects, suggesting it should be the preferred choice for symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Schulman, CC.[2019]

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 494 patients with benign prostatic hyperplasia (BPH), tamsulosin 0.4 mg significantly improved lower urinary tract symptoms (LUTS) more than tamsulosin 0.2 mg and placebo, with a notable reduction in the International Prostate Symptom Score (IPSS).

Both doses of tamsulosin were well-tolerated, with no serious adverse effects reported, indicating that tamsulosin 0.4 mg is a safe and effective option for treating symptomatic BPH in Asian men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial. Chung, JH., Oh, CY., Kim, JH., et al.[2022]

In a study of 51 Thai patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), Tamsulosin OCAS® significantly reduced symptoms, as shown by a decrease in the International Prostate Symptom Score (IPSS) from 19.52 to 6.08 after 8 weeks (p < 0.001).

The treatment also improved quality of life and nocturia episodes, with only mild side effects reported, indicating that Tamsulosin OCAS® is both effective and safe for managing LUTS in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of oral Tamsulosin controlled absorption system (OCAS) for the treatment of lower urinary tract symptoms due to bladder outlet obstruction associated with benign prostatic hyperplasia: an open-label preliminary study. Lojanapiwat, B., Permpongkosol, S.[2022]

In a study of 100 men with benign prostatic hyperplasia (BPH), both alfuzosin and tamsulosin significantly improved lower urinary tract symptoms (LUTS) and urinary flow rates, showing their efficacy in treating BPH-related issues.

Switching between alfuzosin and tamsulosin within the same individuals led to similarly favorable outcomes, suggesting that if one medication is ineffective, the other may provide better relief without affecting prostate-specific antigen (PSA) levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized crossover comparison of tamsulosin and alfuzosin in patients with urinary disturbances caused by benign prostatic hyperplasia. Karadağ, E., Öner, S., Budak, YU., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[A randomized long-term comparative study of clinical efficacy of alpha 1-blocker with or without antiandrogen therapy for benign prostatic hyperplasia: focusing on improvement of I-PSS]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Tamsulosin MR and OCAS (modified release and oral controlled absorption system): current therapeutic uses. [2018]

4. Australia pubmed.ncbi.nlm.nih.gov

α1-Blockers for the treatment of recurrent urinary tract infections in women with dysfunctional voiding: a prospective randomized study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia. [2019]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

The efficacy and safety of oral Tamsulosin controlled absorption system (OCAS) for the treatment of lower urinary tract symptoms due to bladder outlet obstruction associated with benign prostatic hyperplasia: an open-label preliminary study. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized crossover comparison of tamsulosin and alfuzosin in patients with urinary disturbances caused by benign prostatic hyperplasia. [2022]