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The Safety and Effectiveness of UroLift: LIFT Pivotal Study (LIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01294150
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : August 13, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
NeoTract, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Benign Prostatic Hyperplasia
Interventions Device: UroLift System
Other: Cystoscopy
Device: Crossover
Enrollment 206
Recruitment Details The first subject was enrolled into the L.I.F.T. clinical study on February 8, 2011. Study enrollment was completed on December 14, 2011 and the final subject reached the 12-month study endpoint on December 5, 2012.
Pre-assignment Details Washout of for 3 months (5ARI) and 2 week (alpha blocker) required before baseline questionnaires.
Arm/Group Title UroLift System Cystoscopy (Control/Sham)
Hide Arm/Group Description The treatment group subjects underwent the UroLift (UL)system procedure. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to be retreated with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months were considered treatment failures, but started their follow-up schedule over. All subjects will be followed at a minimum of 5 years per the assessment schedule. The control group subjects underwent a cystoscopy procedure. The subject was blinded as to whether he was randomized to the control or treatment group. Unblinding occurred at 3 months post procedure after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo procedure with the UroLift system, provided he met the inclusion and exclusion criteria. Subjects crossing over are then to be followed for 5 years post-treatment. If subject did not crossover, his participation was not required beyond the 12 month visit.
Period Title: Overall Study
Started 140 66
Completed 138 64
Not Completed 2 2
Reason Not Completed
Physician Decision             2             2
Arm/Group Title UroLift System Cystoscopy Total
Hide Arm/Group Description Average of 4.9 implants per prostate implanted. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction. Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure. Total of all reporting groups
Overall Number of Baseline Participants 140 66 206
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 66 participants 206 participants
67  (8.6) 65  (8.0) 66  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 66 participants 206 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
140
 100.0%
66
 100.0%
206
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 66 participants 206 participants
Hispanic or Latino
2
   1.4%
3
   4.5%
5
   2.4%
Not Hispanic or Latino
136
  97.1%
63
  95.5%
199
  96.6%
Unknown or Not Reported
2
   1.4%
0
   0.0%
2
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 66 participants 206 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
5
   3.6%
0
   0.0%
5
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.5%
1
   0.5%
Black or African American
2
   1.4%
3
   4.5%
5
   2.4%
White
131
  93.6%
62
  93.9%
193
  93.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   1.4%
0
   0.0%
2
   1.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 66 participants 206 participants
United States 94 45 139
Canada 20 10 30
Australia 26 11 37
1.Primary Outcome
Title Collection of Post-treatment Catheterization for Safety
Hide Description The primary safety endpoint is an assessment of the rate of extended post-operative urinary catheterization in the subjects randomized to the UroLift group of the study in the ITT group. The extended post-operative urinary catheterization rate is defined as including those subjects who required catheterization within the first 3 days as part of post-operative management for inability to void, and required the catheter for more than 7 days. 2/140 met this endpoint.
Time Frame Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UroLift System
Hide Arm/Group Description:
The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
Overall Number of Participants Analyzed 140
Measure Type: Number
Unit of Measure: participants
2
2.Primary Outcome
Title Comparison of IPSS for Efficacy
Hide Description

The UroLift system will be considered superior to the Control if the mean International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 months demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for cystoscopy alone.

The IPSS is an 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).

SCORING:

0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic

Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UroLift System Cystoscopy
Hide Arm/Group Description:
The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
Overall Number of Participants Analyzed 140 66
Mean (Standard Deviation)
Unit of Measure: IPSS total score
11.1  (7.67) 5.9  (7.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection UroLift System, Cystoscopy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Assuming unequal variances comparing mean improvement in the UL group to 125% of the mean improvement in the Control group. A p-value of 0.025 or less associated with UL is considered evidence of statistical significance
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Mean UroLift Improvement in IPSS at 12 Months
Hide Description 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). Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. To meet co-primary effectiveness endpoint, the lower bound of a one-sided 97.5% confidence interval of IPSS mean percent change from baseline at Month 12 in the UroLift group must be greater than or equal to 30%.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UroLift System
Hide Arm/Group Description:
The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
Overall Number of Participants Analyzed 140
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: % IPSS Score Improvement
45.5 [1] 
(38.3 to NA)
[1]
This was a one-sided confidence interval
4.Secondary Outcome
Title Sexual Function
Hide Description Over the 12 month follow-up period, the proportion of UroLift patients who experience de novo sustained erectile dysfunction and retrograde ejaculation will be reported. Control subjects are not included in this analysis since controls could crossover option opened at 3 months.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title UroLift System
Hide Arm/Group Description:
The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
Overall Number of Participants Analyzed 140
Measure Type: Number
Unit of Measure: % of Subjects
0.0
Time Frame Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit.
Adverse Event Reporting Description All reported AEs are presented, including unrelated to device/procedure. The majority of the non-serious adverse events were deemed mild or moderate. No UADEs were reported through 5 Year Visit.
 
Arm/Group Title UroLift System Crossover Cystoscopy
Hide Arm/Group Description The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months. The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
All-Cause Mortality
UroLift System Crossover Cystoscopy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/140 (6.43%)      4/53 (7.55%)      0/13 (0.00%)    
Hide Serious Adverse Events
UroLift System Crossover Cystoscopy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/140 (37.14%)      19/53 (35.85%)      0/13 (0.00%)    
Cardiac disorders       
Atrial fibrillation  1 [1]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Coronary artery disease  1 [2]  2/140 (1.43%)  2 1/53 (1.89%)  1 0/13 (0.00%)  0
Ischaemic cardiomyopathy  1 [3]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Myocardial infarction  1  7/140 (5.00%)  7 0/53 (0.00%)  0 0/13 (0.00%)  0
Angina pectoris  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Cardiac arrest  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Endocrine disorders       
Thyroid disorder  1  2/140 (1.43%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders       
Pancreatitis  1  2/140 (1.43%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Pancreatitis chronic  1 [4]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
General disorders       
Chills  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Hepatobiliary disorders       
Hepatic cirrhosis  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Infections and infestations       
Respiratory tract infection  1  1/140 (0.71%)  1 1/53 (1.89%)  1 0/13 (0.00%)  0
Sepsis  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Urinary tract infection  1  2/140 (1.43%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Cellulitis  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Diverticulitis  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Injury, poisoning and procedural complications       
Hip fracture  1 [5]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Post procedural haemorrhage  1 [6]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Whiplash injury  1 [7]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Abscess  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Facial bones fracture  1 [8]  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Road traffic accident  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Testicular injury  1 [9]  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  3/140 (2.14%)  3 1/53 (1.89%)  1 0/13 (0.00%)  0
Back pain  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Spinal osteoarthritis  1 [10]  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Gastrointestinal stromal tumour  1  2/140 (1.43%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Leukaemia  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Metastatic renal cell carcinoma  1 [11]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Metastatic squamous cell carcinoma  1 [12]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Pancreatic carcinoma  1 [13]  2/140 (1.43%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Prostate cancer  1  2/140 (1.43%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Renal cancer  1  2/140 (1.43%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Thyroid cancer  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Head and neck cancer  1 [14]  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Multiple myeloma  1 [15]  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Other, L2 Paraganglioma WHO grade 1  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Nervous system disorders       
Cerebral haemorrhage  1 [16]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Dementia  1 [17]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Haemorrhage intracranial  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Renal cancer metastatic  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Transient global amnesia  1 [18]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Transient ischaemic attack  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Carotid artery stenosis  1 [19]  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Renal and urinary disorders       
Calculus urinary  1  3/140 (2.14%)  3 1/53 (1.89%)  1 0/13 (0.00%)  0
Nephrolithiasis  1 [20]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Residual urine  1  1/140 (0.71%)  1 1/53 (1.89%)  1 0/13 (0.00%)  0
Nocturia  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Urine flow decreased  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Embolism pulmonary  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Nasal septum deviation  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Pneumonia aspiration  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Pneumothorax  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Respiratory failure  1  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Surgical and medical procedures       
Haematuria  1 [21]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Cataract operation  1  1/140 (0.71%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Coronary artery bypass  1 [22]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Hip arthroplasty  1 [23]  1/140 (0.71%)  2 0/53 (0.00%)  0 0/13 (0.00%)  0
Joint arthroplasty  1 [5]  1/140 (0.71%)  1 1/53 (1.89%)  2 0/13 (0.00%)  0
Transurethral prostatectomy  1  3/140 (2.14%)  3 2/53 (3.77%)  2 0/13 (0.00%)  0
Knee arthroplasty  1 [24]  0/140 (0.00%)  0 1/53 (1.89%)  1 0/13 (0.00%)  0
Coronary Arterial Stent Insertion  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Vascular disorders       
Arteriosclerosis  1  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Arteriovenous fistula  1 [25]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Deep vein thrombosis  1 [26]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
Peripheral vascular disorder  1 [27]  1/140 (0.71%)  1 1/53 (1.89%)  1 0/13 (0.00%)  0
Venous insufficiency  1 [28]  1/140 (0.71%)  1 0/53 (0.00%)  0 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
[1]
Cardiac Arrythmia
[2]
1 = Shortness of breath
[3]
ischemic cardiomyopathy related to class II heart failure
[4]
Metastatic Pancreatic Cancer
[5]
right hip fracture
[6]
Post-operative hemorrhage from a laparoscopic right inguinal hernia
[7]
whiplash/headbump
[8]
Fractured Nose
[9]
Epididymitis
[10]
Lumbar spondylosis
[11]
Recurrent renal cell carcinoma with metastasis
[12]
Metastatic Poorly Differentiated Squamous Cell Carcinoma
[13]
Diagnosis of pancreatic cancer
[14]
Pinna Cancer
[15]
mulitple myeloma with metastatic disease to bones
[16]
Brain Hemorrhage
[17]
frontotemporal dementia
[18]
Episode of apparent partial transient global amnesia
[19]
Severe Right Carotid Artery Stenosis
[20]
renal stone left side
[21]
Highly probable related to procedure and device
[22]
Coronary artery disease
[23]
Left Hip Replacement Right Hip Replacement
[24]
rt knee replacement
[25]
cognard dural fistula
[26]
Blood Clot in Right Leg
[27]
Peripheral vascular disease - Right lower limb
[28]
Chronic venous insufficiency - bilateral leg vein ligations
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
UroLift System Crossover Cystoscopy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   133/140 (95.00%)      49/53 (92.45%)      0/13 (0.00%)    
Gastrointestinal disorders       
Constipation  1  1/140 (0.71%)  1 3/53 (5.66%)  3 0/13 (0.00%)  0
Infections and infestations       
Urinary tract infection  1  13/140 (9.29%)  15 8/53 (15.09%)  11 0/13 (0.00%)  0
Investigations       
Prostatic specific antigen increased  1  10/140 (7.14%)  10 5/53 (9.43%)  6 0/13 (0.00%)  0
Renal and urinary disorders       
Dysuria  1  54/140 (38.57%)  57 21/53 (39.62%)  21 0/13 (0.00%)  0
Haematuria  1  47/140 (33.57%)  52 15/53 (28.30%)  15 0/13 (0.00%)  0
Micturation Urgency  1  20/140 (14.29%)  20 10/53 (18.87%)  11 0/13 (0.00%)  0
Pelvic Pain  1  28/140 (20.00%)  32 11/53 (20.75%)  12 0/13 (0.00%)  0
Urinary Incontinence  1  21/140 (15.00%)  21 4/53 (7.55%)  4 0/13 (0.00%)  0
Urinary Retention  1  10/140 (7.14%)  10 4/53 (7.55%)  4 0/13 (0.00%)  0
Calculus urinary  1  19/140 (13.57%)  19 11/53 (20.75%)  11 0/13 (0.00%)  0
Nocturia  1  10/140 (7.14%)  10 2/53 (3.77%)  2 0/13 (0.00%)  0
Pollakiuria  1  10/140 (7.14%)  10 5/53 (9.43%)  5 0/13 (0.00%)  0
Residual urine  1  7/140 (5.00%)  7 1/53 (1.89%)  1 0/13 (0.00%)  0
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator agreements restricted data disclosure until written agreement by or publication by Sponsor. The first publication appeared in the Journal of Urology, June 2013. "The Prostatic Urethral Lift for the Treatment of Lower Urinary Tract Symptoms Associated with Prostate Enlargement Due to Benign Prostatic Hyperplasia: The L.I.F.T. Study " Claus G. Roehrborn, Steven N. Gange, Neal D. Shore, Jonathan L. Giddens, et al. The Vol. 190, Issue 6, Pages 2161-2167.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emily Hergenreter Director of Clinical Affairs
Organization: NeoTract
Phone: 650-739-5570
EMail: ehergenreter@neotract.com
Layout table for additonal information
Responsible Party: NeoTract, Inc.
ClinicalTrials.gov Identifier: NCT01294150    
Other Study ID Numbers: 1012CP
First Submitted: February 7, 2011
First Posted: February 11, 2011
Results First Submitted: April 1, 2014
Results First Posted: August 13, 2015
Last Update Posted: September 5, 2018