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

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ClinicalTrials.gov Identifier: NCT01294150

Recruitment Status : Completed

First Posted : February 11, 2011

Results First Posted : August 13, 2015

Last Update Posted : September 5, 2018

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

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)
Arm/Group Description	The treatment group subjects underw...	The control group subjects underwen...
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

Baseline Characteristics

Arm/Group Title		UroLift System	Cystoscopy	Total
Arm/Group Description		Average of 4.9 implants per prostat...	Sham treatment entailed rigid cysto...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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

Outcome Measures

1.Primary Outcome


Title	Collection of Post-treatment Catheterization for Safety
Description	The primary safety endpoint is an assessment of the rate of extended p...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	UroLift System
Arm/Group Description:	The treatment group subjects underw...
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
Description	The UroLift system will be considered superior to the Control if the m...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	UroLift System	Cystoscopy
Arm/Group Description:	The treatment group subjects underw...	The control group subjects underwen...
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)

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
Description	The International Prostate Symptom Score (IPSS) is a standardized 8 qu...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	UroLift System
Arm/Group Description:	The treatment group subjects underw...
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
Description	Over the 12 month follow-up period, the proportion of UroLift patients...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	UroLift System
Arm/Group Description:	The treatment group subjects underw...
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

Adverse Events

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
Arm/Group Description	The treatment group subjects underw...		Between 3 and 12 month follow-up as...		The control group subjects underwen...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

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