Surgery vs. Medication for Benign Prostatic Hyperplasia

(IMPACT Trial)

Overseen By Rogers Mitchell

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: NeoTract, Inc.

Must not be taking: Alpha blockers, PDE5 inhibitors

Disqualifiers: Urinary infection, Prostate cancer, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).

Will I have to stop taking my current medications?

Yes, you may need to stop taking your current BPH medications. If you are using an alpha blocker or a daily phosphodiesterase type 5 inhibitor for BPH, you must stop for 30 days before joining the trial. If you are using 5-alpha-reductase inhibitors, you must not have used them within 6 months of starting the trial.

What data supports the effectiveness of the drug Tamsulosin Hydrochloride for treating benign prostatic hyperplasia?

Research shows that Tamsulosin Hydrochloride significantly improves symptoms of benign prostatic hyperplasia, such as reducing residual urine and increasing urine flow rate, with minimal side effects. It is also effective in managing lower urinary tract symptoms in chronic prostatitis, enhancing quality of life. ^{1 2 3 4 5}

Is tamsulosin safe for treating benign prostatic hyperplasia?

Tamsulosin, also known as Flomax or Omnic, has been studied for its safety in treating benign prostatic hyperplasia and related conditions. Long-term studies show it is generally safe, with a low risk of serious side effects, although some patients may experience slight changes in lab results. It is effective in reducing urinary symptoms and the risk of acute urinary retention, which is a sudden inability to urinate. ^{1 3 5 6 7}

How does the drug Tamsulosin differ from other treatments for benign prostatic hyperplasia?

Tamsulosin is a drug that works by relaxing the muscles in the prostate and bladder neck, making it easier to urinate. It is taken orally once a day and is effective for long-term management of symptoms, offering a non-surgical option for patients with benign prostatic hyperplasia. ^{1 2 3 8 9}

Research Team

Claus Roehrborn, MD

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

This trial is for males aged 45 or older with symptoms of benign prostatic hyperplasia (BPH), indicated by an IPSS score between 8 and 30. Participants must be willing to stop current BPH medications if needed, have no history of certain prostate treatments, and not suffer from conditions like urinary tract infections or severe allergies to specific metals.

Inclusion Criteria

I am a suitable candidate for the BPH treatments being studied.

I am a man aged 45 or older.

I am willing and able to attend follow-up appointments.

Exclusion Criteria

I currently have a urinary tract infection or prostatitis.

Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint

My PSA level is over 10 ng/ml, but prostate cancer has been ruled out.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Prostatic Urethral Lift procedure or Tamsulosin HCl 0.4mg

3 months

Follow-up

Participants are monitored for changes in quality of life and BPH symptoms after treatment

3 months

Treatment Details

Interventions

• Tamsulosin Hydrochloride
• UroLift System

Trial Overview The study compares two BPH therapies: the UroLift System procedure versus tamsulosin hydrochloride medication. It's a randomized controlled trial where participants are assigned randomly to either treatment group in equal numbers across multiple US sites.

Participant Groups

Group I: Prostatic Lift Active Control 1 Intervention

Treatment with the UroLift System

Group II: Medication Active Control 1 Intervention

Treatment with Tamsulosin HCl 0.4mg

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?

NeoTract, Inc.

Lead Sponsor

Trials

11

Recruited

3,400+

Findings from Research

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 40 men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), both Tadalafil and Tamsulosin significantly improved symptoms and quality of life, with no significant differences in effectiveness between the two drugs.

Tadalafil was found to provide better improvements in erectile function compared to Tamsulosin, and patients who did not respond to one medication often showed improvement when switched to the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tamsulosin and tadalafil in relieving benign prostatic hyperplasia related symptoms: A randomized double blind placebo controlled cross-over study. Pattanaik, S., Sandhu, HS., Mavuduru, RS., et al.[2023]

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 male patients with lower urinary tract symptoms and overactive bladder, combining tamsulosin (TAM) with solifenacin (SOL) significantly improved symptoms and quality of life for those with storage symptoms compared to TAM alone, based on a study of 172 participants.

Conversely, for patients with voiding symptoms, tamsulosin alone was more effective than the combination with solifenacin, highlighting the importance of tailoring treatment based on the specific bothersome symptom.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we decide the optimal initial treatment for male lower urinary tract symptoms patients with overactive bladder by the most bothersome symptom? A randomized, prospective, open-label study. Yun, JH., Kim, JH., Kim, JH., et al.[2018]

This study aims to evaluate the feasibility of using the PERSONAL app to conduct individualized n-of-1 trials for older men with lower urinary tract symptoms (LUTS) currently taking tamsulosin, allowing for personalized assessments of treatment effectiveness and side effects.

By involving 20 participants aged over 65 in a structured trial comparing tamsulosin to placebo over 11 weeks, the research seeks to determine the acceptability and usefulness of this approach in making informed decisions about long-term tamsulosin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PERSONAL: Feasibility Study Protocol for Placebo-Controlled, Randomized n-of-1 Trials of Tamsulosin for Lower Urinary Tract Symptoms. Bauer, SR., Breyer, BN., Oni-Orisan, A., et al.[2021]

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]

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]

Alpha(1)1-adrenergic receptor antagonists, particularly tamsulosin, are the first-line treatment for benign prostatic hyperplasia (BPH) symptoms, used by 80% of physicians due to their proven efficacy.

In a study of patients treated with tamsulosin for 6 years, 80.7% showed a consistent positive response with a very low incidence of orthostatic hypotension, indicating both effectiveness and safety over the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of tamsulosin for benign prostatic hyperplasia. Narayan, P., Tunuguntla, HS.[2022]

Tamsulosin (0.4 mg once daily) effectively improves lower urinary tract symptoms in patients of all ages, showing significant benefits regardless of age group.

Patients with severe symptoms experienced substantial improvements, often moving to moderate or mild symptom categories, suggesting tamsulosin is a viable alternative to surgery even for those with severe symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of tamsulosin efficacy in subgroups of patients with lower urinary tract symptoms. Michel, MC., Mehlburger, L., Bressel, HU., et al.[2019]

References

1. 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]

2. India pubmed.ncbi.nlm.nih.gov

Efficacy of tamsulosin and tadalafil in relieving benign prostatic hyperplasia related symptoms: A randomized double blind placebo controlled cross-over study. [2023]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Can we decide the optimal initial treatment for male lower urinary tract symptoms patients with overactive bladder by the most bothersome symptom? A randomized, prospective, open-label study. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

PERSONAL: Feasibility Study Protocol for Placebo-Controlled, Randomized n-of-1 Trials of Tamsulosin for Lower Urinary Tract Symptoms. [2021]

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

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

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

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

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

Long-term efficacy and safety of tamsulosin for benign prostatic hyperplasia. [2022]

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

Comparison of tamsulosin efficacy in subgroups of patients with lower urinary tract symptoms. [2019]