BPH-6: Comparison of the UroLift System to TURP for Benign Prostatic Hyperplasia

NeoTract

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: UroLift System; Procedure: Transurethral Resection of the Prostate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01533038

CP12317

Details and patient eligibility

About

The purpose of this study is to compare the UroLift System Treatment to Transurethral Resection of the Prostate (TURP) in improving a patient's overall quality of life, while evaluating healthcare expenditures associated with each therapy.

Full description

The study is a prospective, consecutive, multi-center, 1:1 randomized study (UroLift System:TURP). The study is intended to be conducted at up to 20 different centers in Europe and Canada to enroll up to 100 subjects.

Subject follow-up visits are at 2 weeks, 1, 3, 6, 12 and 24 months for all subjects.

Enrollment: 80 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men >50 years old with moderate-severe BPH

Exclusion criteria

• Size, width of prostate
• Other medical condition or co-morbidity contraindicative for TURP or UroLift

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

UroLift System

Active Comparator group

Description:

UroLift System procedure

Treatment:

Device: UroLift System

Transurethral Resection of the Prostate

Active Comparator group

Description:

Transurethral Resection of the Prostate surgery

Treatment:

Procedure: Transurethral Resection of the Prostate