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Treatment Response to Xiaflex for Men With Peyronie's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774264
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

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

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 2, 2021
Estimated Study Completion Date : December 2, 2021

Resource links provided by the National Library of Medicine


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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774264


Contacts
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Contact: Manuel Molina, MD 305-243-4873 m.molina.leyba@miami.edu
Contact: Ranjith Ramasamy, MD 305-243-4562 ramasamy@miami.edu

Locations
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United States, Florida
Department of Urology, University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Madhumita Parmar    305-243-4873    m.parmar@med.miami.edu   
Principal Investigator: Ranjith Ramasamy, MD         
Sponsors and Collaborators
University of Miami
Endo Pharmaceuticals
Investigators
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Principal Investigator: Ranjith Ramasamy, MD University of Miami
Publications of Results:
Other Publications:
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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    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Penile Induration
Penile Diseases
Connective Tissue Diseases