Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum

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

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.

Study Overview

• Status: Completed
• Conditions: Peyronie Disease

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Peyronie's disease stable for more than 3 months after 12 to 18 months of evolution

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peyronie's Disease Questionnaire (PDQ)	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	every 4 weeks for 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penile curvature angulation	Penile curvature angulation : Change in baseline penile curvature angulation each 4 weeks, i.e. before each new injection ; for up 2 years	every 4 weeks for 2 years

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Sexual dysfunction; Collagenase Clostridium Histolyticum; Xiapex®; Peyronie's Disease Questionnaire (PDQ)
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Penile Diseases; Penile Induration
• Other Study ID Numbers: RECHMPL20_0202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No