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Completed

NCT Number: NCT03774264

Treatment Response to Xiaflex for Men With Peyronie's Disease

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.

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Key information

Conditions

Peyronie Disease Connective Tissue Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Penile Induration Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Department of Urology, University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study title

Treatment Response to Xiaflex Based on Ultrasound Characterization of Plaque for Men With Peyronie's Disease

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2018
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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