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The purpose of the study is to evaluate the safety and effectiveness of the UroLift(R) System when used in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the improvement of International Prostate Symptom Score (IPSS) and safety will be reviewed based on pertinent adverse events.
The randomized portion of the study is a prospective, multicenter, multinational, 2:1 randomized, single-blinded controlled clinical trial comparing the IPSS of the treatment group to the IPSS of the control group at the 3 month follow-up. Subjects in the active treatment group undergo UroLift system treatment. Subjects in the control group undergo a cystoscopy procedure.
All subjects will be followed through 12 months, and through 5 years for those that receive the investigational device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UroLift System | Active Comparator | The treatment group subjects underwent the UroLift system procedure. The subject was blinded to his randomization into control or treatment group. Unblinding will occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to retreat 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 started their follow-up schedule over and were considered treatment failures. All UL subjects will be followed a minimum of 5 years. |
|
| Cystoscopy | Sham Comparator | The control group subjects underwent a cystoscopy procedure. The subject was blinded to his randomization into the control or treatment group. Unblinding will 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 a UL procedure if he met crossover inclusion and exclusion criteria. Subjects crossing over will then be followed for 5 years post-treatment. The subject can also be treated by other approved therapies, or receive no treatment at all, which would require participation through 12 months. |
|
| Crossover | Active Comparator | Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo a UL procedure if he met crossover inclusion and exclusion criteria. Subjects crossing over will then be followed for 5 years post-treatment. The subject can also be treated by other approved therapies, or receive no treatment at all, which would require participation through 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UroLift System | Device | The NeoTract UroLift System is a medical device approved for sale in the United States, European Union, and several other countries (see www.urolift.com). It was developed for the treatment of lower urinary tract symptoms (LUTS) associated with 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of Post-treatment Catheterization for Safety | 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. | Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days |
| Comparison of IPSS for Efficacy | 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 | 3 month |
| Mean UroLift Improvement in IPSS at 12 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). 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%. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Function | 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. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Roehrborn, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Research LLC | San Diego | California | 92123 | United States | ||
| Shahram S. Gholami MD - A Professional Corp. |
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Washout of for 3 months (5ARI) and 2 week (alpha blocker) required before baseline questionnaires.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | UroLift System | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cystoscopy | Other | The Control Group will undergo cystoscopy. |
|
| Crossover | Device | Subjects crossed over and received the UroLift System from the Control Group. |
|
| San Jose |
| California |
| 95124 |
| United States |
| Urology Associates of Denver | Englewood | Colorado | 80113 | United States |
| Advanced Urology Institute | Daytona Beach | Florida | 32114 | United States |
| Pinellas Urology | St. Petersburg | Florida | 33710 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Chesapeake Urology | Baltimore | Maryland | 21237 | United States |
| Sheldon J. Freedman, M.D., Ltd. | Las Vegas | Nevada | 89144 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Scott and White Healthcare | Temple | Texas | 76504 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| Figtree Private Hospital | Figtree | New South Wales | 2525 | Australia |
| Austin Hospital | Heidelberg | Victoria | Australia |
| Port Macquarie Urology Centre | Port Macquarie | 2444 | Australia |
| Oakville Trafalgar Memorial Hospital | Oakville | Ontario | L6J 3L7 | Canada |
| Cam Am HIFU | Toronto | Ontario | MSG 1E2 | Canada |
| FG001 | Cystoscopy (Control/Sham) | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | UroLift System | 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. |
| BG001 | Cystoscopy | Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Collection of Post-treatment Catheterization for Safety | 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. | Posted | Number | participants | Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days |
|
|
| |||||||||||||||||||||||||||
| Primary | Comparison of IPSS for Efficacy | 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 | Posted | Mean | Standard Deviation | IPSS total score | 3 month |
| ||||||||||||||||||||||||||||
| Primary | Mean UroLift Improvement in IPSS at 12 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). 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%. | Posted | Number | 97.5% Confidence Interval | % IPSS Score Improvement | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Sexual Function | 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. | Posted | Number | % of Subjects | 12 Months |
|
|
Comparison safety data between two cohorts (we are listing 3 arms UroLift system, Cystoscopy and Crossover) at Index procedure through 5 Year Visit.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UroLift System | 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. | 9 | 140 | 52 | 140 | 133 | 140 |
| EG001 | Crossover | 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. | 4 | 53 | 19 | 53 | 49 | 53 |
| EG002 | Cystoscopy | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematuria | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment | Highly probable related to procedure and device |
|
| Arteriosclerosis | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (13.1) | Systematic Assessment | cognard dural fistula |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (13.1) | Systematic Assessment | Cardiac Arrythmia |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (13.1) | Systematic Assessment | Brain Hemorrhage |
|
| Chills | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Coronary artery bypass | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment | Coronary artery disease |
|
| Coronary artery disease | Cardiac disorders | MedDRA (13.1) | Systematic Assessment | 1 = Shortness of breath |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (13.1) | Systematic Assessment | Blood Clot in Right Leg |
|
| Dementia | Nervous system disorders | MedDRA (13.1) | Systematic Assessment | frontotemporal dementia |
|
| Embolism pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment | Left Hip Replacement Right Hip Replacement |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment | right hip fracture |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (13.1) | Systematic Assessment | ischemic cardiomyopathy related to class II heart failure |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment | right hip fracture |
|
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment | Recurrent renal cell carcinoma with metastasis |
|
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment | Metastatic Poorly Differentiated Squamous Cell Carcinoma |
|
| Myocardial infarction | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment | renal stone left side |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment | Diagnosis of pancreatic cancer |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment | Metastatic Pancreatic Cancer |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA (13.1) | Systematic Assessment | Peripheral vascular disease - Right lower limb |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment | Post-operative hemorrhage from a laparoscopic right inguinal hernia |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Renal cancer metastatic | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Residual urine | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Thyroid disorder | Endocrine disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA (13.1) | Systematic Assessment | Episode of apparent partial transient global amnesia |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA (13.1) | Systematic Assessment | Chronic venous insufficiency - bilateral leg vein ligations |
|
| Whiplash injury | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment | whiplash/headbump |
|
| Abscess | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (13.1) | Systematic Assessment | Severe Right Carotid Artery Stenosis |
|
| Cellulitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment | Fractured Nose |
|
| Head and neck cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment | Pinna Cancer |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment | rt knee replacement |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment | mulitple myeloma with metastatic disease to bones |
|
| Nocturia | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment | Lumbar spondylosis |
|
| Testicular injury | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment | Epididymitis |
|
| Urine flow decreased | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Other, L2 Paraganglioma WHO grade 1 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Coronary Arterial Stent Insertion | Surgical and medical procedures | MedDRA (13.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysuria | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Micturation Urgency | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pelvic Pain | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (13.1) | Systematic Assessment |
| |
| Residual urine | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Hergenreter Director of Clinical Affairs | NeoTract | 650-739-5570 | ehergenreter@neotract.com |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| D018592 | Cross-Over Studies |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Canada |
|
| Australia |
|
|
|
|
|
|