NCT03774264|Completed
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Sponsor study identifier
observational
80
1 country
1
Study Start
September 2, 2018
Actual (reported)Primary Completion
July 2, 2021
Actual (reported)Study Completion
July 2, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2018
Actual (reported)December 3, 2018
Actual (reported)December 12, 2018
Actual (reported)July 2, 2021
Actual (reported)July 2, 2021
Actual (reported)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
International Index of Erectile Function (IIEF) Scores
52 weeks
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.
Participant with previous diagnosed Peyronie's Disease will be included into the observational study at the University of Miami, Professional Art Center.
Department of Urology, University of Miami
Miami, Florida, 33136, United States
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.
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.
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.
Ranjith Ramasamy, MD
University of Miami
80 participants (actual enrollment reported by the registry).
First Submitted
December 3, 2018
First Posted
December 12, 2018
Study Start
September 2, 2018
Actual (reported)Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
Contact the study team to confirm eligibility.
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.
Primary Completion
July 2, 2021
Actual (reported)Study Completion
July 2, 2021
Actual (reported)Last Updated
September 29, 2021
Record last verified: 2021-09
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