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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04370652

Enrollment

156

Registered

2020-05-01

Start date

2015-01-01

Completion date

2019-12-30

Last updated

2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peyronie Disease

Keywords

Collagenase Clostridium Histolyticum, Xiapex®, Peyronie's Disease Questionnaire (PDQ), Sexual dysfunction

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Peyronie's Disease Questionnaire (PDQ)	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

Measure	Time frame	Description
Penile curvature angulation	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

Countries

France

Outcome results