Not yet recruiting NCT07680543

ProVIDE Studies Post Exit Analysis

— Observational BPH With Symptomatic Lower Urinary Tract Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: ProVee Urethral Expander System.
Who it may be relevant to: Registry conditions: BPH With Symptomatic Lower Urinary Tract Symptoms. Basic parameters: from 45 years · Male.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Detailed description

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

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

Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy. [Time frame: Up to 36 months]

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 Subjects who withdrew consent or were withdrawn by site Study PI.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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Center list to be confirmed — check the primary protocol.

NCT: NCT07680543 · CIP-004