Treatment Response to Xiaflex for Men With Peyronie's Disease

Completed

• Conditions: Peyronie Disease

• Registration Number: NCT03774264
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-02
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Primary Completion: 2021-07-02
• Study Completion: 2021-07-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ).	52 weeks	The PDQ is highly responsive to treatment-related change in men with PD. It measures penile pain in patients with PD. It is intended for men who have had vaginal intercourse in the past 3 months, which evaluate the levels of pain or discomfort based on last erection or vaginal intercourse. The range of scores is from 0-30 points, with higher scores signifying greater penile pain or discomfort.
Goniometer measurement to determine degree of curvature of PD.	52 weeks	Evaluate the total degree change of curvature improvement after treatment with Xiaflex measured by goniometer, an instrument that measures the angle of the curvature to determine the degree of the PD.
Psychosexual changes in Peyronie's Disease Questionnaire (PDQ).	52 weeks	The PDQ is highly responsive to treatment-related change in men with PD. It is self-administered, that measures psychosexual consequences after the presentation of PD. It is intended for men who have had vaginal intercourse in the past 3 months. The range of scores is from 0-24 points, with higher scores signifying greater psychosexual consequences from PD.

Secondary Outcome Measures

Name	Time	Method
International Index of Erectile Function (IIEF) Scores	52 weeks	The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi- dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions, with a range of scores from 0-75, with lower scores signifying poorer erectile function.

Trial Locations

Locations (1)

Department of Urology, University of Miami; 🇺🇸 Miami, Florida, United States