Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH.
The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data.
Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2.
The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.
Men with Peyronie's Disease
Older than 18 years old
Curvature ≥30 degrees
Ability to achieve an erection satisfactory for intercourse with or without phosphodiesterase-5 (PDE5) inhibitors
Prior surgical treatment on the penis (other than circumcision)
Prior treatment with CCH injections
Any contraindications to CCH - as determined by the PI
Single group
Collagenase Clostridium Histolyticum
Drug4 Series given to each participant, 6 weeks apart. Medication administered on back-to-back days. If failing to achieve an adequate response, men may receive up to 2 additional series 9-12 months after the 4th series. Total of 0.9 mg administered with each series, diluted to 0.8 mL
RestoreX
DeviceRestorex initiated beginning on post-injection day 3 or as soon as tolerated - 30 min daily, continuing until 6 weeks after final injection of the final CCH series.
Sildenafil
DrugMen will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Penile Curvature
Compare penile curvature between baseline and post-treatment in men 1 year after completing the final injection series. A goniometer (protractor) will be used to measure from the penile angulation during a full erection in two planes (dorsal/ventral and lateral). Measurements will be in degrees.
Penile Length
Compare penile length between baseline and post-treatment in men 1 year after completing the final injection series. Measurements will be performed using a ruler, with measurements obtained from the pubic symphysis to the corona of the glans penis (measured in cm).
Penile curvature compared to more aggressive technique
Compare curvature outcomes to our historical series of men treated up-front with the more aggressive technique. This will be done using a goniometer (protractor) with a full erection and measured in two planes (dorsal/ventral and lateral). The curvature will be measured using degrees.
Penile curvature compared to our current salvage approach for CCH
Compare curvature changes to those in our ongoing randomized, controlled trial (NCT05108558) evaluating the salvage approach in men who previously failed 6-8 CCH injections. This will be done using a goniometer (protractor) with a full erection and measured in two planes (dorsal/ventral and lateral). The curvature will be measured using degrees.
Adverse Events
Report subjectively noted adverse events (AE) at 1 year following the final injection series. Patients will be able to write-in specific adverse events, and absolute occurrences of each of the written responses will be summed and reported.
Partner Support
Evaluate partner support as a predictor of whether the patient continues with treatment. Support will be assessed using a non-validated question, "How supportive are you of your partner's decision to undergo Xiaflex treatments?" This will be measured using the selectable options: Very Supportive, Somewhat Supportive, Neutral, Somewhat Unsupportive, and Very Unsupportive.
Click on the lead sponsor to view all of their trials.
Charitable Union for the Research and Education of Peyronie's Disease
Lead sponsor
Endo USA Inc., a Keenova Therapeutics Company
Collaborator
