Clinical trial NCT01876706: UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Official title: L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: UroLift System
Lead sponsor: NeoTract, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-13
Enrollment: 51
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.

Detailed description: The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.

Eligibility criteria: Inclusion Criteria:

* Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH)

Exclusion Criteria:

* Size, volume,length of prostate

Primary outcomes:
measure: Quality of Recovery
timeFrame: 1 Month
Secondary outcomes:
measure: IPSS Scores at Baseline and 12 Month Follow-up
timeFrame: 12 Months
measure: IPSS 12 Month Change From Baseline
timeFrame: 12 Months
measure: IPSS 12 Month Percent (%) Change From Baseline
timeFrame: 12 Months
measure: BPH II Scores at Baseline and 12 Month Follow-up
timeFrame: 12 Month
measure: BPH II 12 Month Percent (%) Change From Baseline
timeFrame: 12 Months
measure: BPH II 12 Month Change From Baseline
timeFrame: 12 Months
measure: Qmax Scores at Baseline and 12 Month Follow-up
timeFrame: 12 Month
measure: QMAX 12 Month Change Minus Baseline
timeFrame: 12 Months
measure: QMAX 12 Month Percent (%) Change in mL/Sec From Baseline
timeFrame: 12 Months
measure: Pain Tolerability Throughout the UroLift System Procedure
timeFrame: 12 Month
measure: BPHII Baseline and 12 Month Median Score, 95% CI
timeFrame: 12 Month
measure: IPSS at Baseline and 12 Months, Median , 95% CI
timeFrame: 12 Month
measure: QMAX Median at Baseline and 12 Months With CI 95%
timeFrame: 12 Month
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Genesis Research LLC
state: California
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology
state: Florida
city: Baltimore
country: United States
facility: Chesapeake Urology
state: Maryland
city: Las Vegas
country: United States
facility: Sheldon J. Freedman, M.D., Ltd.
state: Nevada
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Grand Strand Urology
name: Neal D Shore, MD
role: PRINCIPAL_INVESTIGATOR
References: