Clinical trial NCT04786106: Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's
Official title: Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Peyronie's Disease
Keywords: collagenase clostridium histolyticum
RestoreX
plication
incision and grafting
surgery
Lead sponsor: Charitable Union for the Research and Education of Peyronie's Disease
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2021-03-08
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of Peyronie's Disease.

Detailed description: After eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile traction therapy (CCH + PTT) group or to the surgery + penile traction therapy (surgery + PTT) group. Those in the CCH + PTT group will receive the full 4 series of 8 Xiaflex injections with 1-3 days between each set of 2 injections and 6 weeks prior to the next series. Patients would then use the RestoreX traction device throughout the series to 3 months post-treatment. Those that were assigned the surgery + PTT treatment protocol would undergo surgery using either penile plication or incision and grafting, depending on the degree of curvature and erectile function. Traction using RestoreX will also be prescribed to these men 2-4 weeks post-operatively until 3 months post-treatment. Key clinical outcomes of both treatment protocols will be compared.

Eligibility criteria: Inclusion Criteria:

* Men with PD
* \>18 years old
* Curvature ≥30 degrees
* Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors

Exclusion Criteria:

* Prior treatment with CCH or surgery
* Moderate (shadowing) or severe (\>1 cm) penile calcification
* Any contraindications to CCH, PTT, or surgery - as determined by the PI

Primary outcomes:
measure: Overall satisfaction with treatment
timeFrame: 1 year
measure: Subjective reporting of erectile dysfunction post treatment
timeFrame: 1 year
measure: Subjective reporting of changes in penile sensation post treatment
timeFrame: 1 year
measure: Subjective reporting of changes in penile length post treatment
timeFrame: 1 year
measure: International Index of Erectile Function, Erectile Function Domain (IIEF) Scores
timeFrame: 1 year
Secondary outcomes:
measure: Peyronie's Disease Questionnaire (PDQ) Scores
timeFrame: 1 year
measure: International Index of Erectile Function (IIEF) Scores
timeFrame: 1 year
measure: Beck's Depression Inventory (BDI) Scores
timeFrame: 1 year
measure: Penile Curvature
timeFrame: 1 year
measure: Objective measurements of penile length post treatment (compared to pre-treatment)
timeFrame: 1 year
measure: Interventions required
timeFrame: 1 year
measure: Hospitalizations
timeFrame: 1 year
measure: Non-standardized questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Orem
country: United States
facility: The Male Fertility and Peyronie's Clinic
state: Utah
Study officials:
References: