The Safety and Effectiveness of UroLift: LIFT Pivotal Study (LIFT)
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| ClinicalTrials.gov Identifier: NCT01294150 |
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Recruitment Status :
Completed
First Posted : February 11, 2011
Results First Posted : August 13, 2015
Last Update Posted : September 5, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Benign Prostatic Hyperplasia | Device: UroLift System Other: Cystoscopy Device: Crossover | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 206 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | July 5, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: UroLift System
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.
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Device: UroLift 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. |
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Sham Comparator: Cystoscopy
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.
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Other: Cystoscopy
The Control Group will undergo cystoscopy. |
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Active Comparator: Crossover
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.
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Device: Crossover
Subjects crossed over and received the UroLift System from the Control Group. |
- Collection of Post-treatment Catheterization for Safety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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%.
- Sexual Function [ Time Frame: 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.
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294150
Show 19 study locations
| Principal Investigator: | Claus Roehrborn, MD | University of Texas Southwestern Medical Center |
| Responsible Party: | NeoTract, Inc. |
| ClinicalTrials.gov Identifier: | NCT01294150 |
| Other Study ID Numbers: |
1012CP |
| First Posted: | February 11, 2011 Key Record Dates |
| Results First Posted: | August 13, 2015 |
| Last Update Posted: | September 5, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Prostatic Hyperplasia Hyperplasia Pathologic Processes Prostatic Diseases |