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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two treatments for men with benign prostatic hyperplasia (BPH), a condition causing symptoms like frequent urination. Participants will either undergo a Prostatic Urethral Lift, a procedure that lifts and holds the enlarged prostate tissue away, or take the medication tamsulosin (also known as Flomax or Omnic). The trial aims to determine which treatment better improves symptoms. Men diagnosed with BPH and experiencing symptoms such as frequent urination may be suitable for this study. As a Phase 4 trial, the treatments have already received FDA approval and proven effective, providing an opportunity to assess their benefits for more patients.

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 is the safety track record for these treatments?

Research shows that both the UroLift System and tamsulosin are generally safe for treating benign prostatic hyperplasia (BPH).

The UroLift System, a simple procedure approved by the FDA, works well and is easy to tolerate over time, according to studies. Patients often feel better within weeks, and this improvement can last up to a year. While the procedure is usually safe, it may have some risks or side effects that a doctor can explain.

Tamsulosin, also known as Flomax, is a pill approved for BPH. Long-term studies have shown it is safe and easy to tolerate for up to six years. Most people do not experience serious side effects, although some might feel mild dizziness because the medication can affect blood pressure.

Both treatments are well-established options for BPH, and their safety is well-documented. Always consult a healthcare professional to determine which option is best. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for Benign Prostatic Hyperplasia (BPH) because they offer novel approaches to managing the condition. The UroLift System is distinctive as it physically lifts and holds the enlarged prostate tissue out of the way, thus relieving urinary symptoms without cutting or removing tissue. This is different from traditional medications like Tamsulosin Hydrochloride, which works by relaxing the muscles in the prostate and bladder neck to improve urine flow. The UroLift procedure is minimally invasive and can potentially provide immediate symptom relief, reducing the need for long-term medication.

What evidence suggests that this trial's treatments could be effective for benign prostatic hyperplasia?

This trial will compare the effectiveness of the UroLift System and Tamsulosin Hydrochloride in treating benign prostatic hyperplasia (BPH). Research has shown that the UroLift System effectively treats an enlarged prostate, with studies finding a 62% improvement in symptoms just two months after treatment. Most patients also experienced better urine flow, with benefits lasting up to four years. Importantly, this treatment does not cause new sexual problems, which is a significant advantage.

For Tamsulosin Hydrochloride, another treatment option in this trial, research has demonstrated its long-term effectiveness in relieving BPH symptoms. About 80% of patients had consistent positive results over six years. It starts working quickly after the first dose and is generally safe and well-tolerated. Both treatments provide reliable options for managing BPH symptoms. ^{1 3 5 6 7}

Who Is on the Research Team?

Claus Roehrborn, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. 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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21362308/

Long-term efficacy and safety of tamsulosin hydrochloride ... Background: Tamsulosin hydrochloride can significantly improve benign prostatic hyperplasia (BPH) symptoms after the first dose and achieve long-term efficacy ...

3. auajournals.org auajournals.org/doi/10.1097/01.ju.0000076140.68657.fd

Long-term Safety and Efficacy of Tamsulosin for the ... Tamsulosin provided sustained relief of symptoms and urine flow for up to 6 years with high levels of safety and tolerability, and no decrease in the drug ...

4. urotoday.com urotoday.com/volume-6-2013/vol-6-issue-2/57989-a-randomized-clinical-study-to-compare-the-efficacy-and-safety-of-naftopidil-versus-tamsulosin-in-symptomatic-benign-prostatic-hyperplasia.html

A Randomized Clinical Study to Compare the Efficacy and ... Conclusions: The management of symptomatic BPH, with either naftopidil or tamsulosin, appeared to be equally effective, safe, and well tolerated. Naftopidil ...

5. nature.com nature.com/articles/s41598-024-61977-5

Comparative efficacy and safety of alpha-blockers as ... Our study revealed that among all the α-blocker monotherapy, tamsulosin 0.4 mg is more effective in improving the IPSS, PVR and Qmax, compared ...

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

Tamsulosin (oral route) - Side effects & dosage However, tamsulosin will not shrink the prostate. The prostate may continue to get larger. This may cause the symptoms to become worse over time ...

7. proudp.com proudp.com/post/tamsulosin-long-term-safety

Flomax long-term safety: How many years is it safe? Learn about the long-term safety of tamsulosin (Flomax). Data shows persistence drops from 37% at 1 year to 18% at 5 years.