Clinical trial NCT03774264: Treatment Response to Xiaflex for Men With Peyronie's Disease
Official title: Treatment Response to Xiaflex Based on Ultrasound Characterization of Plaque for Men With Peyronie's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peyronie Disease
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2018-12-12
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Psychosexual changes in Peyronie's Disease Questionnaire (PDQ).
timeFrame: 52 weeks
measure: Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ).
timeFrame: 52 weeks
measure: Goniometer measurement to determine degree of curvature of PD.
timeFrame: 52 weeks
Secondary outcomes:
measure: International Index of Erectile Function (IIEF) Scores
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Department of Urology, University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Ranjith Ramasamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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-controlled, phase III studies. BJU Int. 2015 Oct;116(4):650-6. doi: 10.1111/bju.13096. Epub 2015 May 18.
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.