Treatment Response to Xiaflex for Men With Peyronie's Disease

NCT03774264 | Completed

• 1 other identifier: 20180188
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Peyronie Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• International Index of Erectile Function (IIEF) Scores

  52 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

Department of Urology, University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (5)

• 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.

  PMID: 22802839 BACKGROUND

• 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.

  PMID: 24119147 BACKGROUND

• 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.

  PMID: 23376148 RESULT

• 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.

  PMID: 25711400 RESULT

• 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.

  PMID: 23230545 RESULT

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ranjith Ramasamy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Male Fertility and Andrology, University of Miami

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 12, 2018
• Study Start: September 2, 2018
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)