Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum

Peyronie Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370652
• Other study ID #: RECHMPL20_0202
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Penile Induration
• Peyronie Disease

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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