Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum

NCT04370652 | Completed

• 1 other identifier: RECHMPL20_0202
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Peyronie Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Penile curvature angulation

  every 4 weeks for 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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°

You may not qualify if:

• Surgery for Peyronie's disease before
• Anticoagulation

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Penile Induration; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Edouard Fortier, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: May 1, 2020
• Study Start: January 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 30, 2019
• Last Updated: May 1, 2020

Record last verified: 2020-04

Locations

FR (1)