BPHPhase 4IMPACTNCT04987892
Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH
A Phase 4 study testing UroLift System and Tamsulosin Hydrochloride in people with BPH, run by NeoTract, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- BPH
- What is being tested?
- UroLift System and Tamsulosin Hydrochloride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male 45 years of age or older
- Diagnosis of BPH
- Experiencing symptoms of BPH as indicated by an IPSS ≥8 and ≤30
- Willing to wash out of current BPH medication(s), as applicable
- An appropriate candidate for both BPH therapies evaluated in this study.
- Ability to understand and consent to participate in this study
- Willing and able to participate in follow-up evaluations
Who cannot join
- Use of alpha blocker for BPH unless washed-out for 30 days
- Use of daily phosphodiesterase type 5 inhibitor (PDE5i) for BPH unless washed-out for 30 days
- 5-alpha-reductase inhibitors for BPH used within 6 months of therapy initiation
- Current urinary tract infection or prostatitis
- Current gross hematuria
- Urinary incontinence presumed due to incompetent sphincter
Show all 17Show fewer
- Catheter-dependent urinary retention within 1 month prior to enrollment
- Prostate volume greater than 100 cc as measured by TRUS
- Prostate specific antigen level of greater than 10 ng/ml within one year of enrollment unless prostate cancer has been ruled out
- History of neurogenic or atonic bladder
- History prostate cancer treatment
- Known to be hypersensitive to tamsulosin HCl or any component of tamsulosin HCl capsules
- Known allergy to nickel, titanium, or stainless steel
- Prior minimally invasive or surgical intervention for BPH
- Urethral conditions that may prevent insertion of delivery system into bladder.
- Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
- History of medical, surgical or other conditions that, in the opinion of the investigator, would interfere with the treatment or evaluation of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Neotract
Pleasanton, California, 94588
Rogers Mitchell, 925-329-6493, USPLEClinicalPayments@teleflex.com
About this study
Official title: Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia
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).
Read the detailed description
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).Men 45 or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). BPH symptoms may range from mild (8) to severe (35) on the IPSS scale. All enrolled men must meet selection criteria and be candidates for therapy with both UroLift System and 0.4 mg tamsulosin HCl.
- Conditions
- BPH
- Being tested
- UroLift System, Tamsulosin Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroLift SystemDevice
Prostatic lift
Tamsulosin HydrochlorideDrug
Also called Flomax
Tamsulosin HCl 0.4mg
| Study group | Role | What they receive |
|---|---|---|
| Prostatic Lift | Active comparator | Treatment with the UroLift System Receives: Device: UroLift System |
| Medication | Active comparator | Treatment with Tamsulosin HCl 0.4mg Receives: Drug: Tamsulosin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired comparison of International Prostate Symptom Score (IPSS) percent change
The primary study analysis compares the change in BPH symptoms in the PUL Arm to the change in BPH symptoms in the MED Arm measured 3 months after BPH therapy initiation. This will be measure by International Prostate Symptom Score (IPSS) percent change. IPSS ranges from 0-35, healthier patients have lower scores than patients more effected by BPH symptoms.
Measured: 3 Months after Therapy Initiation
Secondary outcomes (1)
Change in Quality of Life (QoL)
The secondary analysis assesses the change in quality of life (QoL) due to urinary symptoms between the PUL and MED Arms measured 3 months after initiation of BPH therapy. This will be measured by change in QoL, ranging from 0-6. Healthier patients have lower scores than patients more effected by BPH symptoms.
Measured: 3 months after BPH Therapy Initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start6 Dec 2021
- Primary completionMay 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeoTract, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Roehrborn, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987892
- Sponsor's protocol ID
- CP00014
- Acronym
- IMPACT
- Status last verified
- Apr 2023
- First submitted
- 9 Jul 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04987892
- Acronym / sponsor ID
- IMPACT / CP00014
- Conditions
- BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- NeoTract, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).Men 45 or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). BPH symptoms may range from mild (8) to severe (35) on the IPSS scale. All enrolled men must meet selection criteria and be candidates for therapy with both UroLift System and 0.4 mg tamsulosin HCl.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostatic Lift | Active comparator | Device: UroLift SystemTreatment with the UroLift System |
| Medication | Active comparator | Drug: Tamsulosin HydrochlorideTreatment with Tamsulosin HCl 0.4mg |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male 45 years of age or older
- Diagnosis of BPH
- Experiencing symptoms of BPH as indicated by an IPSS ≥8 and ≤30
- Willing to wash out of current BPH medication(s), as applicable
- An appropriate candidate for both BPH therapies evaluated in this study.
Key exclusion criteria (17 listed)
- Use of alpha blocker for BPH unless washed-out for 30 days
- Use of daily phosphodiesterase type 5 inhibitor (PDE5i) for BPH unless washed-out for 30 days
- 5-alpha-reductase inhibitors for BPH used within 6 months of therapy initiation
- Current urinary tract infection or prostatitis
- Current gross hematuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UroLift SystemProstatic lift | Device | Prostatic Lift |
| Tamsulosin HydrochlorideAlso: FlomaxTamsulosin HCl 0.4mg | Drug | Medication |
Primary outcome
Paired comparison of International Prostate Symptom Score (IPSS) percent change
Time frame: 3 Months after Therapy Initiation
The primary study analysis compares the change in BPH symptoms in the PUL Arm to the change in BPH symptoms in the MED Arm measured 3 months after BPH therapy initiation. This will be measure by International Prostate Symptom Score (IPSS) percent change. IPSS ranges from 0-35, healthier patients have lower scores than patients more effected by BPH symptoms.
1 secondary outcome
Change in Quality of Life (QoL)
Time frame: 3 months after BPH Therapy Initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
Related trials for BPH
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Roehrborn, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing UroLift System and Tamsulosin Hydrochloride in people with BPH, run by NeoTract, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rogers Mitchell (805-403-7107, rogers.mitchell@neotract.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired comparison of International Prostate Symptom Score (IPSS) percent change (time frame: 3 Months after Therapy Initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.