Benign Prostatic Hyperplasia (BPH)
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEUroLift System procedure
Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
Sponsors
NeoTract, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enlarged median lobe (ML) contributing to obstruction of the prostate * BPH
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. | 6 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). 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up | 12 Months | Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up |
| Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up | 12 Months | 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). |
| Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up | 12 Months | 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). |
| Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up | 12 Months | 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. |
| Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up | 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). 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 Peak Flow Rate Scores at Baseline and 12 Month Follow-up | 12 Months | 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. |
| Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up | 12 Months | 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. |
| Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up | 12 Months | 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. |
| Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up | 12 Months | 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. |
| Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up | 12 Months | Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UroLift Arm Subjects that undergo the UroLift System procedure. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | UroLift Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| IPSS Baseline | 24.2 Scores on a scale STANDARD_DEVIATION 4.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 36 / 45 |
| serious Total, serious adverse events | 5 / 45 |
Outcome results
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.
Time frame: 6 months
Population: Intent to treat Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift System Procedure | At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%. | 57.7 percent change |
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
Time frame: 12 Months
Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift System Procedure | Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up | -70.4 percent change |
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.
Time frame: 12 Months
Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UroLift System Procedure | Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up | Baseline BPHII | 7.7 BPHII score | Standard Deviation 2.8 |
| UroLift System Procedure | Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up | 12 Month BPHII | 2.1 BPHII score | Standard Deviation 2.5 |
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
Time frame: 12 Months
Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift System Procedure | Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up | -55.1 percent change |
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.
Time frame: 12 Months
Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UroLift System Procedure | Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up | Baseline IPSS | 24.1 Score on a scale | Standard Deviation 5 |
| UroLift System Procedure | Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up | 12 Month IPSS | 10.6 Score on a scale | Standard Deviation 7 |
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.
Time frame: 12 Months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift System Procedure | Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up | 108.4 percent change |
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.
Time frame: 12 Months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UroLift System Procedure | Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up | Baseline Qmax | 7.1 mL/sec | Standard Deviation 2.7 |
| UroLift System Procedure | Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up | 12 Month Qmax | 13.5 mL/sec | Standard Deviation 7.6 |
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.
Time frame: 12 Months
Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift System Procedure | Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up | -4.8 percent change |
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.
Time frame: 12 Months
Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UroLift System Procedure | Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up | Baseline PVR | 108.5 mL | Standard Deviation 80.5 |
| UroLift System Procedure | Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up | 12 Month PVR | 69.9 mL | Standard Deviation 77 |
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).
Time frame: 12 Months
Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| UroLift System Procedure | Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up | -61.1 percent change |
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).
Time frame: 12 Months
Population: 44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UroLift System Procedure | Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up | Baseline QOL | 4.9 score on a scale | Standard Deviation 0.8 |
| UroLift System Procedure | Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up | 12 Month QOL | 1.9 score on a scale | Standard Deviation 1.3 |