NCT04271020

Brief Summary

UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 22, 2020

Completed
Last Updated

June 11, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

February 4, 2020

Results QC Date

April 23, 2020

Last Update Submit

May 26, 2020

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (3)

  • Qmax Assessed Using Urodynamic Testing (Cystometry)

    Qmax is the the maximum urinary flow rate measured in ml/s.

    3 Month

  • Pdet at Qmax Assessed Using Urodynamic Testing (Cystometry)

    Pdet is detrusor pressure at Qmax (maximum urinary flow rate) measured in cm H2O.

    3 Month

  • Pdetmax Assessed Using Urodynamic Testing (Cystometry)

    Pdetmax is the maximum void pressure measured in cm H2O.

    3 Month

Study Arms (1)

UroLift

EXPERIMENTAL
Device: UroLift

Interventions

UroLiftDEVICE

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to 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.

UroLift

Eligibility Criteria

Age45 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPatients must be male. The study is evaluation the population of men diagnosed with benign prostatic hyperplasia.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male gender
  • Diagnosis of symptomatic BPH
  • Age ≥ 45 years
  • International Prostate Symptom Score (IPSS) ≥ 13
  • Peak urine flow rate ≤ 12 ml/sec, voided volume ≥ 125 ml
  • Prostate volume ≤ 80 cc per ultrasound

You may not qualify if:

  • Current urinary retention
  • Post void residual (PVR) urine \> 250 ml
  • Have an obstructive or protruding median lobe of the prostate
  • Active urinary tract infection at time of treatment
  • Current gross hematuria
  • Previous BPH surgical procedure
  • Previous pelvic surgery or irradiation
  • History of neurogenic or atonic bladder
  • Stress urinary incontinence
  • Biopsy of the prostate within the past 6 weeks
  • Life expectancy estimated to be less than 1 year
  • History of prostate or bladder cancer
  • Elevated Prostate-Specific Antigen (PSA) without ruling out prostate cancer
  • History of compromised renal function or upper tract disease
  • Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midtown Urology Associates

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Emily Friedland, Director, Global Clinical Affairs
Organization
NeoTract, Inc.
emily.friedland@teleflex.com
1-610-331-7299

Study Officials

  • Brian Mazzarella, MD

    Midtown Urology Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 17, 2020

Study Start

October 25, 2018

Primary Completion

April 22, 2019

Study Completion

November 27, 2019

Last Updated

June 11, 2020

Results First Posted

May 22, 2020

Record last verified: 2020-05

Locations

US(1)