Tamsulosin for Urinary Tract Infections

(FOLI Trial)

Recruiting at 2 trial locations

Overseen By Shishir K. Maithel

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Emory University

Must not be taking: Tamsulosin, PDE5 inhibitors

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

212 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tamsulosin, a medication, can reduce urination issues after surgery. Often, people struggle to urinate properly once their catheter is removed, causing discomfort and possible infections. The trial includes two groups: one takes tamsulosin after surgery, while the other receives standard care without medication. Men over 50 scheduled for elective surgery might be suitable candidates, especially if they are concerned about post-surgery urinary problems. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment validation.

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.

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

Research has shown that tamsulosin, also known as Flomax, is generally safe for use. A large study conducted over six months found that tamsulosin was as safe as a placebo (a harmless pill used to compare effects in drug tests). Another study revealed that patients who took tamsulosin for up to six years continued to do well, with only a few experiencing dizziness when standing up quickly.

The most common side effects of tamsulosin include urinary tract infections, vomiting, fever, and headaches, affecting at least 5% of users. However, the likelihood of serious side effects remains low, making tamsulosin a relatively safe choice for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for urinary tract infections?

Researchers are excited about using tamsulosin for urinary tract infections (UTIs) because it offers a unique approach compared to traditional antibiotics. Most treatments for UTIs involve antibiotics that target the bacteria causing the infection. However, tamsulosin works differently by relaxing the muscles in the urinary tract, which could help alleviate symptoms more quickly and potentially reduce the risk of infection recurrence. This different mechanism of action may provide faster relief and an alternative for patients who cannot use or do not respond well to antibiotics.

What evidence suggests that tamsulosin might be an effective treatment for postoperative urinary retention and catheter-associated urinary tract infections?

Research has shown that tamsulosin, which participants in this trial may receive, can improve urine flow and ease symptoms related to urinary issues. Other studies found that people taking tamsulosin experienced better urine flow and an improved quality of life concerning urinary problems. Tamsulosin relaxes muscles in the urinary system, helping to prevent issues like difficulty urinating after surgery. Although typically used for prostate issues, this muscle-relaxing effect might also reduce the risk of urinary tract infections linked to catheters. Overall, tamsulosin shows promise in easing urinary symptoms, making it a possible option for those facing these challenges after surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Kenneth Cardona, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Tamsulosin

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Flomax for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Approved in United States as Flomax for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

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+

Published Research Related to This Trial

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 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]

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 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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11743300/

Tamsulosin for treating lower urinary tract symptoms ... Conclusions: Tamsulosin improves lower urinary tract symptoms and flow. Its effectiveness was similar to that of other alpha-antagonists, increasing slightly at ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6676853/

Predictive value of the immediate effect of first dose ... The first dose of tamsulosin improves UFM and predicts the mid-term change in UFM as well as IPSS and QoL indices in the treatment of BPH-related LUTS.

3. withpower.com withpower.com/trial/phase-3-urinary-tract-infections-1-2024-6abf6

Tamsulosin for Urinary Tract Infections (FOLI Trial) Research suggests that Tamsulosin, commonly used for prostate issues, may help with urinary tract problems by relaxing muscles in the urinary system, ...

4. mayoclinic.org mayoclinic.org/drugs-supplements/tamsulosin-oral-route/description/drg-20068275

Tamsulosin (oral route) - Side effects & dosage This may help increase the flow of urine or decrease the symptoms. However, tamsulosin will not shrink the prostate. The prostate may continue to get larger.

5. urotoday.com urotoday.com/volume-2-2009/vol-2-issue-1/26733-longterm-efficacy-of-tamsulosin-in-the-treatment-of-lower-urinary-tract-symptoms-suggestive-of-benign-prostatic-hyperplasia-in-reallife-practice-2219640.html

Long-Term Efficacy of Tamsulosin in the Treatment ... Results: Of these patients, 72 (64%) remained on tamsulosin (12 to 48 months of treatment) and 41 (36%) withdrew after a mean of 17.4 months on average. Reasons ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2014481/

A 6-month large-scale study into the safety of tamsulosin We conclude that tamsulosin has a good safety profile relative to AE rates in the placebo arms of previous studies on tamsulosin even in the presence of most ...

7. 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.

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 primary outcome was any incident of tamsulosin discontinuation during the index hospital stay. Secondary outcomes included rates of POUR, rates of urinary ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf

Flomax - accessdata.fda.gov The most frequently reported adverse events (≥5%) from the pooled data of both studies were urinary tract infection, vomiting, pyrexia, headache ...