Treatment Response to Xiaflex for Men With Peyronie's Disease

• ClinicalTrials.gov Identifier: NCT03774264
• Recruitment Status: Completed
• First Posted: December 12, 2018
• Last Update Posted: September 29, 2021
• Sponsor: University of Miami
• Collaborator: Endo Pharmaceuticals
• Information provided by (Responsible Party): Ranjith Ramasamy, MD, University of Miami

Study Description

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.

Condition or disease
Peyronie Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Treatment Response to Xiaflex Based on Ultrasound Characterization of Plaque for Men With Peyronie's Disease
• Actual Study Start Date: September 2, 2018
• Actual Primary Completion Date: July 2, 2021
• Actual Study Completion Date: July 2, 2021

Groups and Cohorts

Group/Cohort

Xiaflex group; 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.

Outcome Measures

Primary Outcome Measures :

1. Psychosexual changes in Peyronie's Disease Questionnaire (PDQ). [ Time Frame: 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.
2. Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ). [ Time Frame: 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.
3. Goniometer measurement to determine degree of curvature of PD. [ Time Frame: 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.

Secondary Outcome Measures :

1. International Index of Erectile Function (IIEF) Scores [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Participant with previous diagnosed Peyronie's Disease will be included into the observational study at the University of Miami, Professional Art Center.

Criteria

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

Contacts and Locations

Locations

United States, Florida

Department of Urology, University of Miami

Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Endo Pharmaceuticals

Investigators

• Principal Investigator: Ranjith Ramasamy, MD; University of Miami

More Information

Publications of Results:

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, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul;190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31. Review.

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-controlled, phase III studies. BJU Int. 2015 Oct;116(4):650-6. doi: 10.1111/bju.13096. Epub 2015 May 18.

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.

Other Publications:

Pawłowska 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.

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.

• Responsible Party: Ranjith Ramasamy, MD, Director of Male Fertility and Andrology, University of Miami, University of Miami
• ClinicalTrials.gov Identifier: NCT03774264
• Other Study ID Numbers: 20180188
• First Posted: December 12, 2018
• Last Update Posted: September 29, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Penile Induration; Penile Diseases; Connective Tissue Diseases