Benign Prostatic Hyperplasia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUroLift System
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.
OTHERCystoscopy
The Control Group will undergo cystoscopy.
DEVICECrossover
Subjects crossed over and received the UroLift System from the Control Group.
Sponsors
NeoTract, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)
Exclusion criteria
* Size, volume,length of prostate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of Post-treatment Catheterization for Safety | Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days | 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. |
| Comparison of IPSS for Efficacy | 3 month | 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 |
| Mean UroLift Improvement in IPSS at 12 Months | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function | 12 Months | 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. |
Countries
Australia, Canada, United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 140 |
| Cystoscopy Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure. | 66 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 2 |
Baseline characteristics
| Characteristic | Cystoscopy | Total | UroLift System |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 8 | 66 years STANDARD_DEVIATION 8.6 | 67 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 199 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 62 Participants | 193 Participants | 131 Participants |
| Region of Enrollment Australia | 11 participants | 37 participants | 26 participants |
| Region of Enrollment Canada | 10 participants | 30 participants | 20 participants |
| Region of Enrollment United States | 45 participants | 139 participants | 94 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 66 Participants | 206 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 140 | 4 / 53 | 0 / 13 |
| other Total, other adverse events | 133 / 140 | 49 / 53 | 0 / 13 |
| serious Total, serious adverse events | 52 / 140 | 19 / 53 | 0 / 13 |
Outcome results
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.
Time frame: Cath within first 3 days post-procedure which extended beyond 7 days, up to 12 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UroLift System | Collection of Post-treatment Catheterization for Safety | 2 participants |
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
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UroLift System | Comparison of IPSS for Efficacy | 11.1 IPSS total score | Standard Deviation 7.67 |
| Cystoscopy | Comparison of IPSS for Efficacy | 5.9 IPSS total score | Standard Deviation 7.66 |
p-value: 0.003t-test, 2 sided
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%.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UroLift System | Mean UroLift Improvement in IPSS at 12 Months | 45.5 % IPSS Score Improvement |
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.
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UroLift System | Sexual Function | 0.0 % of Subjects |