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Completed

NCT Number: NCT04370652

Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum

Peyronie's disease is the appearance of a fibrosis plaque on the albuginea of the corpora cavernosa, which produces mechanical traction at the time of erection, inducing a deformation/curvature of the erect penis. The physiopathology is largely unknown.

There is a significant sexual and psychological impact on patients. Historically, the only possible treatment was surgical. The only drug treatment that was FDA approved for this disease was Collagenase from Clostridium Histolyticum marketed under the name Xiapex® until 31/12/2019 by Sobi laboratory. Marketing was stopped on that date for economic reasons and restricted to the US market only.

The investigators propose a retrospective evaluation of the largest French monocentric series of this treatment from the perspective of the sexual and psychological evaluation of patients.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old
  • Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution
  • Angle of penis deformation ≥ 30°

Exclusion criteria

  • Surgery for Peyronie's disease before
  • Anticoagulation

Treatment and study plan

Primary outcomes

  1. Peyronie's Disease Questionnaire (PDQ)

    Time frame: every 4 weeks for 2 years

    Peyronie's Disease Questionnaire (PDQ) : Change in baseline Peyronie's Disease Questionnaire Score each 4 weeks, i.e. before each new injection ; for up 2 years

Secondary outcomes

  1. Penile curvature angulation

    Time frame: every 4 weeks for 2 years

    Penile curvature angulation : Change in baseline penile curvature angulation each 4 weeks, i.e. before each new injection ; for up 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum (CCH or Xiapex®): Sexual and Psychological Impact and Results From 156 Patients' Questionnaires Data

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 1, 2020
Registry last updated
May 1, 2020

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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