rodynamic changes after placement of the NeoTract® UroLift® System

Phase 4

Completed

• Conditions: 10004994; benign enlargement of the prostate; prostate hyperplasia

• Registration Number: NL-OMON43093
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

•Male gender >=50 years of age
•Prostate volume <= 60 cc per ultrasound
•International Prostate Symptom Score (IPSS) >= 13
•URA of > 29 on PF plot

Exclusion Criteria

Obstructive median lobe
Intravesicle prostatic protrusion > 5mm (identified with TRUS or cystoscopy)
Hypocontractile bladders ( when bladder contractility index (BCI): PdetQmax + 5.Qmax < 100)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The changes in urodynamica parameters (URA, Opening pressure, PdetQmax ) after<br /><br>Urolift therapy</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Symptomatic response and patient satisfaction</p><br>