Not Yet RecruitingNot Applicable

ProVIDE Studies Post Exit Analysis

25 participantsStarted 2026-07-14

Plain-language summary

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

Who can participate

Age range

45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Subjects who withdrew consent or were withdrawn by site Study PI.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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 36 months

Trial details

NCT IDNCT07680543

SponsorProVerum Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-07-31

Contact for this trial

Diane Gargus

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

View on ClinicalTrials.gov More BPH With Symptomatic Lower Urinary Tract Symptoms trials