Benign Prostatic HyperplasiaLOCALNCT01876706

UroLift System TOlerability and ReCovery When Administering Local Anesthesia

A study testing UroLift® System in people with Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: UroLift® System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 7 sitesUnited States
Study dates: Apr 2013to 4 Sep 2018
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

Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Who cannot join

Size, volume,length of prostate

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Chesapeake Urology
Baltimore, Maryland, 21237
Advanced Urology Institute
Daytona Beach, Florida, 32114
Sheldon J. Freedman, M.D., Ltd.
Las Vegas, Nevada, 89144
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Jean Brown Research
Salt Lake City, Utah, 84124
Genesis Research LLC
San Diego, California, 92123
Pinellas Urology
St. Petersburg, Florida, 33710

Other trials in United States

About this study

Official title: L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia

The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.

Read the detailed description

The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.

Conditions: Benign Prostatic Hyperplasia
Being tested: UroLift® System
Keywords: UroLift System
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® SystemDevice
The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. 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 groups in NCT01876706
Study group	Role	What they receive
UroLift® System	Experimental	Single-arm of qualified subjects receiving UroLift® System intervention. Receives: Device: UroLift® System

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Recovery
Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.
Measured: 1 Month

Secondary outcomes (13)

IPSS Scores at Baseline and 12 Month Follow-up
The International Prostate Symptom Score (IPSS) is an 7 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). Lower scores are indicative of less symptoms.
Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
Measured: 12 Months
IPSS 12 Month Change From Baseline
The International Prostate Symptom Score (IPSS) is an 7 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) using a total score from 0 - 35.
The larger number for Change in IPSS Score 12 Month Follow-up from Baseline, demonstrate the improvement in IPSS.
Measured: 12 Months
IPSS 12 Month Percent (%) Change From Baseline
The International Prostate Symptom Score (IPSS) is an 7 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) using a total score from 0 - 35.
The larger Percent (%) Change in IPSS Score at 12 Month Follow-up from Baseline, demonstrates the improvement in IPSS (the mean score was change by X %). Note: Percent (%) Change: is the mean % change of each subject.
Measured: 12 Months
BPH II Scores at Baseline and 12 Month Follow-up
BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.
Questions 1-4:
1. Over the past month how much physical discomfort did any urinary problems cause you? \&
2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.
Measured: 12 Month
BPH II 12 Month Percent (%) Change From Baseline
BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.
Questions 1-4:
1. Over the past month how much physical discomfort did any urinary problems cause you? \&
2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.
Measured: 12 Months
BPH II 12 Month Change From Baseline
BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.
Questions 1-4:
1. Over the past month how much physical discomfort did any urinary problems cause you? \&
2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.
Measured: 12 Months
Qmax Scores at Baseline and 12 Month Follow-up
QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra.
Measured: 12 Month
QMAX 12 Month Change Minus Baseline
QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger number for Change of the QMAX value at 12 Month Follow-up minus Baseline, demonstrate the improvement in QMAX
Measured: 12 Months
QMAX 12 Month Percent (%) Change in mL/Sec From Baseline
QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger Percent (%) Change of the QMAX value at 12 Month Follow-up from Baseline, demonstrate the improvement in QMAX. Note: Percent (%) Change: is the average %change of each subject
Measured: 12 Months
Pain Tolerability Throughout the UroLift System Procedure
Pain Tolerability using questionnaire pelvic pain Visual Analog Scale (VAS) 0-10. A score of 0 (zero) would equal no pain while a score of 10 would equate to pain as bad as patient could imagine. This scale was assessed at different times during procedure as specified in results section.
Measured: 12 Month
BPHII Baseline and 12 Month Median Score, 95% CI
BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.
Questions 1-4:
1. Over the past month how much physical discomfort did any urinary problems cause you? \&
2. Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.
3. Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.
4. Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time.
Measured: 12 Month
IPSS at Baseline and 12 Months, Median , 95% CI
The International Prostate Symptom Score (IPSS) is an 7 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). Lower scores are indicative of less symptoms.
Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
Measured: 12 Month
QMAX Median at Baseline and 12 Months With CI 95%
QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate is obstructive.
Measured: 12 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20134 Sep 2018

First posted13 Jun 2013 (estimated)
Study startApr 2013
Primary completionOct 2014
Study completion4 Sep 2018

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: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01876706
Sponsor's protocol ID: CP12911
Acronym: LOCAL
Status last verified: Mar 2019
First submitted: 6 May 2013
Last updated: 20 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
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Recruiting
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RecruitingObservational study
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Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia
ClinicalTrials.gov ID: NCT01876706
Acronym / sponsor ID: LOCAL / CP12911
Conditions: Benign Prostatic Hyperplasia
Keywords: UroLift System
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: NeoTract, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Oct 2014 (actual)
Study completion: 4 Sep 2018 (actual)
First posted: 13 Jun 2013 (estimated)
Results: Posted 25 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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	Experimental	Device: UroLift® SystemSingle-arm of qualified subjects receiving UroLift® System intervention.

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Key exclusion criteria (1 listed)

Size, volume,length of prostate

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® SystemThe NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. 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® System

Primary outcome

Quality of Recovery
Time frame: 1 Month
Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.

13 secondary outcomes

IPSS Scores at Baseline and 12 Month Follow-up
Time frame: 12 Months
IPSS 12 Month Change From Baseline
Time frame: 12 Months
IPSS 12 Month Percent (%) Change From Baseline
Time frame: 12 Months
BPH II Scores at Baseline and 12 Month Follow-up
Time frame: 12 Month
BPH II 12 Month Percent (%) Change From Baseline
Time frame: 12 Months
BPH II 12 Month Change From Baseline
Time frame: 12 Months
Qmax Scores at Baseline and 12 Month Follow-up
Time frame: 12 Month
QMAX 12 Month Change Minus Baseline
Time frame: 12 Months
QMAX 12 Month Percent (%) Change in mL/Sec From Baseline
Time frame: 12 Months
Pain Tolerability Throughout the UroLift System Procedure
Time frame: 12 Month
BPHII Baseline and 12 Month Median Score, 95% CI
Time frame: 12 Month
IPSS at Baseline and 12 Months, Median , 95% CI
Time frame: 12 Month
QMAX Median at Baseline and 12 Months With CI 95%
Time frame: 12 Month

Results and safety

Results posted to the registry on 25 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UroLift Arm	51	26

Primary outcome: Quality of Recovery

Time frame: 1 Month. Number. Unit: participants

Measure	UroLift Arm n = 51
90 - 100 Score	28
80 - 89 Score	16

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 Years;. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UroLift Arm	12 of 51 (23.5%)	47 of 51 (92.2%)	3 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Benign Prostatic Hyperplasia

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.

Neal D Shore, MD principal investigator

Grand Strand Urology

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing UroLift® System in people with Benign Prostatic Hyperplasia, run by NeoTract, Inc. at 7 sites 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 1 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 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 25 Nov 2015). 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?

Quality of Recovery (time frame: 1 Month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01876706.

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 20 Mar 2019.