Benign Prostatic Hyperplasia (BPH)NCT02625545
Study of Median Lobe Prostatic UroLift Procedure
A study testing UroLift System procedure in people with Benign Prostatic Hyperplasia (BPH), run by NeoTract, Inc..
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- UroLift System procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 17 Feb 2016to 19 Dec 2017
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enlarged median lobe (ML) contributing to obstruction of the prostate
- BPH
Who cannot join
- -
About this study
The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).
Read the detailed description
Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe.
Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study.
Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- UroLift System procedure
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UroLift System procedureDevice
Also called Prostatic UroLift (PUL)
Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
| Study group | Role | What they receive |
|---|---|---|
| UroLift System procedure | Experimental | All eligible,enrolled subjects will undergo a UroLift procedure Receives: Device: UroLift System procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.
The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.
Measured: 6 months
Secondary outcomes (10)
Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up
The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.
Measured: 12 Months
Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up
Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up
Measured: 12 Months
Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up
Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible).
Measured: 12 Months
Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up
Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible).
Measured: 12 Months
Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up
BPHII (Benign Prostatic Hyperplasia Impact Index) is used to assess the impact of BPH symptoms on subject health and functioning. The BPHII is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities. Scores for each question range from 0 to 4, with higher score indicating greater impact. Maximum score is 16.
Measured: 12 Months
Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up
Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up
Measured: 12 Months
Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up
Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate.
Measured: 12 Months
Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up
Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate.
Measured: 12 Months
Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up
Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner.
Measured: 12 Months
Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up
Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start17 Feb 2016
- Primary completion30 May 2017
- Study completion19 Dec 2017
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 Hyperplasia (BPH)Studies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoTract, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan B. Rukstalis, M.D., Principal investigator, Wake Forest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625545
- Sponsor's protocol ID
- CP00001
- Status last verified
- Feb 2019
- First submitted
- 5 Dec 2015
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Median Lobe Prostatic UroLift Procedure
- ClinicalTrials.gov ID
- NCT02625545
- Acronym / sponsor ID
- CP00001
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- NeoTract, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).
Detailed description
Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe.
Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study.
Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UroLift System procedure | Experimental | Device: UroLift System procedureAll eligible,enrolled subjects will undergo a UroLift procedure |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enlarged median lobe (ML) contributing to obstruction of the prostate
- BPH
Key exclusion criteria (1 listed)
- -
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 System procedureAlso: Prostatic UroLift (PUL)Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH | Device | UroLift System procedure |
Primary outcome
At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.
Time frame: 6 months
The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.
10 secondary outcomes
Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up
Time frame: 12 Months
Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dan B. Rukstalis, M.D. principal investigator
Wake Forest
Questions about this trial
What is this clinical trial studying?
A study testing UroLift System procedure in people with Benign Prostatic Hyperplasia (BPH), run by NeoTract, Inc..
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 2 inclusion and 1 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 26 Feb 2019). 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?
At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. (time frame: 6 months). 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 26 Feb 2019.