Benign Prostatic HyperplasiaUDSNCT04271020
Urodynamic Feasibility Study Utilizing the UroLift® System
A study testing UroLift in people with Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 1 site in United States.
Trial summary
UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and… 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
- Benign Prostatic Hyperplasia
- What is being tested?
- UroLift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 27 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 gender
- Diagnosis of symptomatic BPH
- Age ≥ 45 years
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urine flow rate ≤ 12 ml/sec, voided volume ≥ 125 ml
- Prostate volume ≤ 80 cc per ultrasound
Who cannot join
- Current urinary retention
- Post void residual (PVR) urine > 250 ml
- Have an obstructive or protruding median lobe of the prostate
- Active urinary tract infection at time of treatment
- Current gross hematuria
- Previous BPH surgical procedure
Show all 32Show fewer
- Previous pelvic surgery or irradiation
- History of neurogenic or atonic bladder
- Stress urinary incontinence
- Biopsy of the prostate within the past 6 weeks
- Life expectancy estimated to be less than 1 year
- History of prostate or bladder cancer
- Elevated Prostate-Specific Antigen (PSA) without ruling out prostate cancer
- History of compromised renal function or upper tract disease
- Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
- Use of the following medications pre-screening (uroflow, questionnaires):
- Within 4 months of baseline assessment: estrogen, any drug producing androgen suppression, or anabolic steroids
- Within 3 months of baseline assessment: 5-alpha-reductase inhibitors
- Within 2 weeks of baseline assessment: alpha-blockers, gonadotropin-releasing hormonal analogs, anticholinergics or cholinergic medication or phenylephrine, pseudoephedrine, or imipramine medications
- Within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and antispasmodics
- Cystolithiasis within the prior 3 months
- History of co-morbidities that would affect having an elective urological procedure including: prostatitis, conditions that preclude the insertion of the UroLift System.
- Other co-morbidities that could impact the study results such as:
- Severe cardiac arrhythmias uncontrolled by medications or pacemaker
- Congestive heart failure New York Heart Assocation (NYHA) III or IV
- History of uncontrolled diabetes mellitus
- Significant respiratory disease in which hospitalization may be required
- Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
- A known allergy to nickel, titanium, or stainless steel
- Unable or unwilling to complete all required questionnaires and follow up assessments
- Unable or unwilling to sign informed consent form
- Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urodynamic Feasibility Study (UDS)
UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- UroLift
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroLiftDevice
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).
During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
| Study group | Role | What they receive |
|---|---|---|
| UroLift | Experimental | Not described Receives: Device: UroLift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qmax Assessed Using Urodynamic Testing (Cystometry)
Qmax is the the maximum urinary flow rate measured in ml/s.
Measured: 3 Month
Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)
Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.
Measured: 3 Month
Pdetmax Assessed Using Urodynamic Testing (Cystometry)
Pdetmax is the maximum void pressure measured in cm H2O.
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start25 Oct 2018
- Primary completion22 Apr 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoTract, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Mazzarella, MD, Principal investigator, Midtown Urology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271020
- Sponsor's protocol ID
- CP00009
- Acronym
- UDS
- Status last verified
- May 2020
- First submitted
- 4 Feb 2020
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urodynamic Feasibility Study (UDS)
- ClinicalTrials.gov ID
- NCT04271020
- Acronym / sponsor ID
- UDS / CP00009
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NeoTract, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 22 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UroLift | Experimental | Device: UroLift |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male gender
- Diagnosis of symptomatic BPH
- Age ≥ 45 years
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urine flow rate ≤ 12 ml/sec, voided volume ≥ 125 ml
Key exclusion criteria (32 listed)
- Current urinary retention
- Post void residual (PVR) urine > 250 ml
- Have an obstructive or protruding median lobe of the prostate
- Active urinary tract infection at time of treatment
- 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 |
|---|---|---|
| UroLiftThe UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra. | Device | UroLift |
Primary outcome
Qmax Assessed Using Urodynamic Testing (Cystometry)
Time frame: 3 Month
Qmax is the the maximum urinary flow rate measured in ml/s.
Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)
Time frame: 3 Month
Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.
Pdetmax Assessed Using Urodynamic Testing (Cystometry)
Time frame: 3 Month
Pdetmax is the maximum void pressure measured in cm H2O.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Brian Mazzarella, MD principal investigator
Midtown Urology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UroLift in people with Benign Prostatic Hyperplasia, 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 6 inclusion and 32 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: finished, as of the sponsor's last update on 11 Jun 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qmax Assessed Using Urodynamic Testing (Cystometry) (time frame: 3 Month). The study lists 3 primary outcomes in all. 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 11 Jun 2020.