Treatment Response to Xiaflex for Men With Peyronie's Disease

University of Miami

Status: Completed

Conditions: Peyronie Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03774264

20180188

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Xiaflex group

Description:

Patients will be evaluated in our urology clinic at baseline for possible inclusion in our study. All patients at baseline evaluation will be evaluated for duration of symptoms, relationship stability, IIEF and PDQ. All patients will obtain a penile Doppler ultrasound with the aid of a vasoactive substance by a specially trained technician. During this visit, plaque measurements will be taken: location of plaque, distance of plaque from the tip of the penis, degree of curvature measured by goniometer. Ultrasound characteristics will be documented: Type (Type 1: The plaque appears as a thickening of the tunica albuginea without acoustic shadowing. Type 2: A moderately calcified plaque with a typical ultrasound shadow. Type 3: A severely calcified plaque with typical ultrasound shadowing) and Grade of calcification (grade 1 (\<0.3 cm), grade 2 (\>0.3 cm, \<1.5 cm), grade 3 (\>1.5 cm; or ≥ 2 plaques \>1.0 cm). Sample data sheet attached as appendix 2.