CompletedNot Applicable

Treatment Response to Xiaflex for Men With Peyronie's Disease

United States80 participantsStarted 2018-09-02

Plain-language summary

The purpose of this research study is to develop a database of patients with Peyronie's disease who are treated at the University of Miami. The collected data will help the researchers to better understand Peyronie's disease and its response to therapy.

Who can participate

Age range

18 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: * Age ≥18 years * Able to provide informed consent * A stable relationship for ≥3 months * PD symptoms with evidence of stable disease as determined by the investigator * Penile curvature deformity of \>30° to \<90° * Has not had previous surgery for PD * Has not had previous therapy with Xiaflex for PD Exclusion Criteria: * Ventral plaque * Active phase PD * Actively on anticoagulation during time frame of injections * Aspirin 81mg will be eligible for therapy * Hour glass deformity * Previous allergic reaction to Xiaflex * Unwilling to participate * Medically unfit for sexual intercourse as deemed by the principal investigator * Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with Xiaflex injection cycles as deemed by the PI

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

Psychosexual changes in Peyronie's Disease Questionnaire (PDQ).

Timeframe: 52 weeks

Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ).

Timeframe: 52 weeks

Goniometer measurement to determine degree of curvature of PD.

Timeframe: 52 weeks

Trial details

NCT IDNCT03774264

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-02

View on ClinicalTrials.gov More Peyronie Disease trials

Who can participate

Age range

18 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.