Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).
Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe.
Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study.
Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UroLift System procedure | Experimental | All eligible,enrolled subjects will undergo a UroLift procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UroLift System procedure | Device | Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH |
|
| Measure | Description | Time Frame |
|---|---|---|
| At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. | The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up | The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dan B. Rukstalis, M.D. | Wake Forest | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | UroLift System Procedure | All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent to Treat (analysis population)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | UroLift Arm | Subjects that undergo the UroLift System procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. | The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. | Intent to treat Population | Posted | Mean | 95% Confidence Interval | percent change | 6 months |
|
12 Months
Adverse Events reported from Index Procedure through 12 Months follow-up; No Unexpected Adverse Device Events
Not provided
| 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 Procedure | All eligible,enrolled subjects will undergo a UroLift procedure UroLift System procedure: Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia/Heartblock | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhage urinary tract | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment | blood clot in urine |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Hergenreter, Sr. Director of Clinical Affairs | NeoTract/Teleflex | 650-793-5570 | Emily.Hergenreter@Teleflex.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2018 | Oct 2, 2018 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 Months |
| Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up | Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up | 12 Months |
| Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up | Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible). | 12 Months |
| Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up | Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible). | 12 Months |
| Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up | BPHII (Benign Prostatic Hyperplasia Impact Index) is used to assess the impact of BPH symptoms on subject health and functioning. The BPHII is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities. Scores for each question range from 0 to 4, with higher score indicating greater impact. Maximum score is 16. | 12 Months |
| Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up | Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up | 12 Months |
| Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up | Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate. | 12 Months |
| Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up | Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate. | 12 Months |
| Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up | Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner. | 12 Months |
| Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up | Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner. | 12 Months |
| Participants |
|
| 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 |
|
| IPSS Baseline | The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. | Mean | Standard Deviation | Scores on a scale |
|
|
|
| Secondary | Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up | The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic. | 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow up visit. | Posted | Mean | Standard Deviation | Score on a scale | 12 Months |
|
|
|
| Secondary | Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up | Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up | 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. | Posted | Mean | 95% Confidence Interval | percent change | 12 Months |
|
|
|
| Secondary | Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up | Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible). | 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
|
|
|
| Secondary | Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up | Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible). | 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. | Posted | Mean | 95% Confidence Interval | percent change | 12 Months |
|
|
|
| Secondary | Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up | BPHII (Benign Prostatic Hyperplasia Impact Index) is used to assess the impact of BPH symptoms on subject health and functioning. The BPHII is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities. Scores for each question range from 0 to 4, with higher score indicating greater impact. Maximum score is 16. | 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. | Posted | Mean | Standard Deviation | BPHII score | 12 Months |
|
|
|
| Secondary | Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up | Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up | 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. | Posted | Mean | 95% Confidence Interval | percent change | 12 Months |
|
|
|
| Secondary | Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up | Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate. | 37/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. Includes only cases where voided volume is at least 125ml. | Posted | Mean | Standard Deviation | mL/sec | 12 Months |
|
|
|
| Secondary | Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up | Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate. | 37/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. Includes only cases where voided volume is at least 125ml. | Posted | Mean | 95% Confidence Interval | percent change | 12 Months |
|
|
|
| Secondary | Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up | Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner. | 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. | Posted | Mean | Standard Deviation | mL | 12 Months |
|
|
|
| Secondary | Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up | Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner. | 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. | Posted | Mean | 95% Confidence Interval | percent change | 12 Months |
|
|
|
| 0 |
| 45 |
| 5 |
| 45 |
| 36 |
| 45 |
| Cervical spinal stenosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment | cervical spinal stenosis cord compression |
|
| Pain in hip | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment | Right Hip Pain |
|
| Urinary tract infection | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Aspiration pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
|
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment | Urinary urgency |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
Not provided
| D052801 |
| Male Urogenital Diseases |