Surgery vs. Medication for Benign Prostatic Hyperplasia
(IMPACT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: NeoTract, Inc.
Must not be taking: Alpha blockers, PDE5 inhibitors
Disqualifiers: Urinary infection, Prostate cancer, others
No Placebo Group
Prior Safety Data
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.12345
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.13567
How does the drug Tamsulosin differ from other treatments for benign prostatic hyperplasia?
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.
See 4 more
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.
See 14 more
Trial 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 (Alpha Blocker)
- UroLift System (Procedure)
Trial OverviewThe 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
2Treatment groups
Active Control
Group I: Prostatic LiftActive Control1 Intervention
Treatment with the UroLift System
Group II: MedicationActive Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NeotractPleasanton, CA
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Who Is Running the Clinical Trial?
NeoTract, Inc.Lead Sponsor
References
[Clinical evaluation of tamsulosin hydrochloride on bladder outlet obstruction associated with benign prostatic hyperplasia: effect on urethral pressure profile and cystometrogram]. [2018]The efficacy and safety of tamsulosin hydrochloride were evaluated in 54 patients with bladder outlet obstruction associated with benign prostatic hyperplasia. Oral tamsulosin hydrochloride 0.2 mg was administered once daily for 7 weeks. The international prostate symptom score, residual urine, uroflowmetrogram, urethral pressure profile and cystometrogram were obtained before and after treatment. The international prostate symptom score improved significantly, and the residual urine volume and ratio of residual urine decreased significantly. In uroflometry, voided volume, maximum flow rate and average flow rate increased significantly. In urethral pressure profile, prostatic urethral pressure decreased significantly. In cystometry, bladder capacity at the first sensation increased significantly. No adverse reactions except for slight elevation in laboratory data in 3 patients were observed. In conclusion, tamsulosin hydrochloride is a useful drug in the treatment of bladder outlet obstruction associated with benign prostatic hyperplasia.
Efficacy of tamsulosin and tadalafil in relieving benign prostatic hyperplasia related symptoms: A randomized double blind placebo controlled cross-over study. [2023]Tadalafil and Tamsulosin have both been approved for use in the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). This study compared the differential effects of these two on BPH-LUTS using a cross over study design.
[Experience in long term use of tamsulosin (Omnik) in patients with chronic prostatitis]. [2018]Tamsulosin (omnik), a selective adrenoreceptor blocker-alpha 1A/D, was used in a long-term regimen of chronic prostatitis (CP) treatment conducted in 39 patients. Tamsulosin was given in a standard dose of 0.4 mg once a day for 1 year. The IPSS total scores, quality of life (Qol, Q max) and size of the prostate were assessed. Tamsulosin proved highly effective in symptoms of the lower urinary tracts (SLUT) and CP. In patients with exacerbation of CP and with SLUT combination of tamsulosin with antibacterial, antiinflammatory, immunomodulating and symptomatic therapy raises the treatment efficiency. Tamsulosin monotherapy can be recommended for treatment of micturition disorders in patients with nonaggravated CP.
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]To compare the treatment outcome of tamsulosin 0.4 mg (TAM) with or without solifenacin 5 mg (SOL) for the most bothersome symptom in male lower urinary tract symptoms (LUTS) with overactive bladder (OAB).
PERSONAL: Feasibility Study Protocol for Placebo-Controlled, Randomized n-of-1 Trials of Tamsulosin for Lower Urinary Tract Symptoms. [2021]Background: Lower urinary tract symptoms (LUTS) affect more than half of men over age 70 and contribute to both poor health-related quality of life and polypharmacy. Tamsulosin hydrochloride, a selective α1-blocker, is the most common medication used to treat LUTS due to presumed benign prostatic hyperplasia and is often prescribed indefinitely, although not all men benefit from long-term therapy. N-of-1 trials allow for individualized estimates of benefit and harm and could facilitate decisions regarding chronic tamsulosin therapy for LUTS, particularly among older men. Our team developed the PERSONAL (PlacEbo-controlled, Randomized, patient-Selected Outcomes, N-of-1 triALs) app to track daily urinary symptoms and medication side effects for n-of-1 trials among older men with LUTS. Materials and Methods: We will conduct a feasibility study of 20 individual randomized n-of-1 trials using the PERSONAL app to compare tamsulosin (0.4 or 0.8 mg) vs. placebo among older men taking tamsulosin for LUTS. We will include men over age 65 with a smartphone for whom temporary discontinuation of tamsulosin is safe, (e.g., no history of acute retention). Participants will work with research staff to prospectively identify the most important urinary symptoms and medication side effects that they would like to digitally track. Men will then be randomized to 2-week treatment periods of tamsulosin or placebo followed by a 1-week wash-out with placebo, for 4 distinct treatment periods and 3 wash-out periods, totaling 11 weeks. Study medications will be blinded using over-encapsulation of tamsulosin pills and matching placebo. Our primary outcomes for this study will be recruitment and retention of eligible men, completion rates of n-of-1 trials and daily questionnaires using the PERSONAL app, and participants' perceived usefulness of their n-of-1 trial for determining whether tamsulosin is effective for them. Linear mixed effects models with individual-specific intercepts and intervention effects will also be used to estimate within-individual effects of tamsulosin. Discussion: The goal of this innovative study is to establish feasibility and acceptability of using a mobile health app and n-of-1 trials to provide older men with individualized estimates of benefits and harms of chronic tamsulosin therapy for LUTS.
[INCIDENCE OF ACUTE URINARY RETENTION IN PATIENTS WITH PROSTATIC ADENOMA AND 8-YEAR LONG TAMSULOSIN THERAPY]. [2018]This report introduces results of an 8-year study estimating the risk of acute urinary retention in patients with stage I prostatic adenoma. Patients were randomly assigned into two groups. The first group consisted of 331 men was regularly taking Omnic (tamsulosin) 0.4 mg 1 time daily for 8 years as a means of medical therapy. The second group consisted of 334 patients treated with herbal preparations (Gentos, Tadenan or Speman). In the case of acute urinary retention patients were taken to the urological department to release urine from the urinary bladder by catheterization or by the surgical procedure. The incidence of acute urinary retention in group 1 ranged from 0.3 to 1.2% per year and, for a total of 8 years of follow-up was 6.45%. In the second group, it ranged from 1.8 to 7.3% per year, making a total of 36.2%. Therefore, the risk of acute urinary retention in patients receiving Omnic (tamsulosin) was reduced by 5.6 times in comparison with the group of patients treated with herbal medications. Thus, the need for surgery decreased from 27.8 to 6.3%. According to the results of an 8-year long tamsulosin was found as a safe and highly effective means to reduce the risk of acute urinary retention.
Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder. [2021]Tamsulosin is available on prescription as a modified release capsule in the US (Flomax), and in most European countries for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The pharmacokinetics of tamsulosin hydrochloride (HCl) have been extensively studied in adults, but no pharmacokinetic data for paediatrics have been published to date.
Long-term efficacy and safety of tamsulosin for benign prostatic hyperplasia. [2022]The treatment approach for recent benign prostatic hyperplasia has changed since the recent introduction of medical therapies with evidence-based efficacy. The choice of treatment to achieve symptom relief must take into account factors such as clinical benefits, potential for morbidity, probable long-term efficacy, and costs. alpha(1)1-Adrenergic receptor antagonists are the primary therapy for patients with benign prostatic hyperplasia presenting with lower urinary tract symptoms and are used by 80% of physicians as the first-line agent to treat this common condition in the aging male. Tamsulosin has been available in the United States since 1997 and has demonstrated its efficacy. Of patients completing 6 years of treatment, 80.7% demonstrated consistent positive response with extremely low incidence of orthostasis, the response being greatest during the first year and largely maintained over the following 5 years.
Comparison of tamsulosin efficacy in subgroups of patients with lower urinary tract symptoms. [2019]We have compared the results of treatment with tamsulosin (0.4 mg once daily) in subgroups of patients with lower urinary tract symptoms suggestive of benign prostatic obstruction, based on two large-scale, open-label, observational studies. Improvements of IPSS or Q(max) were largely unaffected by patient age. Patients with severe symptoms benefited at least as much from treatment as those with mild or moderate symptoms, and the majority of patients with severe symptoms were shifted to the moderate or even mild symptoms group. We conclude that tamsulosin is effective in patients of all age groups, and should be considered as an alternative to surgery even in patients with severe symptoms.