ProVIDE Studies Post Exit Analysis

N/ANot Yet RecruitingNCT07680543

ProVerum Medical25 enrolled

Overview

A study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.

An analysis of US based subjects who exited from the ProVIDE or ProVIDE II studies.

Study Type

OBSERVATIONAL

Enrollment

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

Interventions

ProVee Urethral Expander SystemDEVICE

ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. US based subjects previously enrolled in the ProVIDE Study or the ProVIDE II Bridging Study who had a ProVee device removed. * 2\. Subjects who withdrew consent or were withdrawn by site Study PI. * 3\. Subjects consented to make data available. Exclusion Criteria: * 1\. Incomplete records available. * 2\. Subjects who exited the studies due to restarting BPH medication while they were enrolled. * 3\. Subjects who did not receive a ProVee in the ProVIDE Study or the ProVIDE II Bridging Study. * 4\. Subjects who exited the studies due to prostate cancer.

Outcomes

Primary Outcomes

Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.

Time frame: Up to 36 months

Central Contacts

Diane Gargus

CONTACT

1-720-472-1504 diane@proverummedical.com

Data from ClinicalTrials.gov

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