Treatment Response to Xiaflex for Men With Peyronie's Disease

Peyronie Disease Clinical Trial

Official title:

Treatment Response to Xiaflex Based on Ultrasound Characterization of Plaque for Men With Peyronie's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774264
• Other study ID #: 20180188
• Status: Completed
• Start date: September 2, 2018
• Est. completion date: July 2, 2021

Study information

• Verified date: September 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Penile Induration
• Peyronie Disease

Locations

Country	Name	City	State
United States	Department of Urology, University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gelbard M, Goldstein I, Hellstrom WJ, McMahon CG, Smith T, Tursi J, Jones N, Kaufman GJ, Carson CC 3rd. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, rando — View Citation

Kalokairinou K, Konstantinidis C, Domazou M, Kalogeropoulos T, Kosmidis P, Gekas A. US Imaging in Peyronie's Disease. J Clin Imaging Sci. 2012;2:63. doi: 10.4103/2156-7514.103053. Epub 2012 Oct 31. — View Citation

Levine L, Rybak J, Corder C, Farrel MR. Peyronie's disease plaque calcification--prevalence, time to identification, and development of a new grading classification. J Sex Med. 2013 Dec;10(12):3121-8. doi: 10.1111/jsm.12334. Epub 2013 Oct 4. — View Citation

Lipshultz LI, Goldstein I, Seftel AD, Kaufman GJ, Smith TM, Tursi JP, Burnett AL. Clinical efficacy of collagenase Clostridium histolyticum in the treatment of Peyronie's disease by subgroup: results from two large, double-blind, randomized, placebo-contr — View Citation

Pawlowska E, Bianek-Bodzak A. Imaging modalities and clinical assesment in men affected with Peyronie's disease. Pol J Radiol. 2011 Jul;76(3):33-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosexual changes in Peyronie's Disease Questionnaire (PDQ).	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.	52 weeks
Primary	Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ).	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.	52 weeks
Primary	Goniometer measurement to determine degree of curvature of PD.	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.	52 weeks
Secondary	International Index of Erectile Function (IIEF) Scores	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.	52 weeks