A Phase 4 interventional study of Collagenase Clostridium Histolyticum and RestoreX in Peyronie Disease, sponsored by Charitable Union for the Research and Education of Peyronie's Disease. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Charitable Union for the Research and Education of Peyronie's Disease · Phase 4, Interventional, and Treatment
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.
The current study would prospectively follow 40 men through the following treatment protocol:
Men would receive 4 series of CCH injections according to the protocol below, which represents a modified version of our most recently published technique.13
If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol.
At the time of initial enrollment, partners of study participants will be invited to enroll in the study and will be administered non-validated questionnaires designed to assess the partner's overall support for the ongoing treatment protocol.
Assessments and study questionnaires will be administered at baseline, with the 1st injection of each series, 6 weeks after completing the 4th series of CCH injections, and 1 year after completion of the final series of CCH injections.
45 studies on the registry are indexed under Penile Induration; 10 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 38 interventional studies indexed under Penile Induration.
Browse Penile Induration studies →Charitable Union for the Research and Education of Peyronie's Disease is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Men would receive 4 series of CCH injections: * Administered on back-to-back days * 0.9 mg administered with each series, diluted to 0.8 mL * Mild in-office modeling performed on treatment day 2 of each series * Wraps applied 2-4 full-time and 2-4 part-time days * Sildenafil 25 mg nightly and Restorex beginning treatment day 2 (sildenafil) or 3 (Restorex - 30 min/day) until 6 weeks after final injection of the final series. Note that men may stop sooner if they are satisfied before completing the 4 series. If the patient is not satisfied with outcomes by the end of the 4th series, they would be permitted to enter the 'salvage' phase of the treatment protocol. * Performed 9-12 months after the 4th series of injections. * The technique would incorporate more aggressive, in-office modeling. * Men would receive up to two additional series per this protocol.
Drug: Collagenase Clostridium Histolyticum · Device: RestoreX · Drug: Sildenafil
4 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
Also known as: Xiaflex, CCH
Restorex 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.
Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Also known as: Viagra
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.
Time frame: 1 year
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).
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Compliance with Therapy - Penile Curvature
Evaluate compliance with therapy as a predictor of penile curvature improvements during the study. A daily diary will be maintained by the patient to track actual device utilization. Patients will record how many minutes that they used the device daily. This information will be used to try to correlate penile curvature outcomes with actual device utilization.
Time frame: 1 year
Satisfaction with therapy
Report patient-outcome measures related to satisfaction with therapy. This measure will be evaluated using a non-standardized question, "How would you rate your overall satisfaction with Xiaflex?" Patients will be able to select from the following responses: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Very Dissatisfied.
Time frame: 1 year
Penile length compared to more aggressive technique
Compare penile length changes to our historical series of men treated up-front with the more aggressive technique. Measurements will be performed using a ruler, with measurements obtained from the pubic symphysis to the corona of the glans penis (measured in cm).
Time frame: 1 year
Penile length compared to our current salvage approach for CCH
Compare penile length changes to our ongoing randomized, controlled trial (NCT05108558) evaluating the salvage approach in men who previously failed 6-8 CCH injections. Measurements will be performed using a ruler, with measurements obtained from the pubic symphysis to the corona of the glans penis (measured in cm).
Time frame: 1 year
Compliance with Therapy - Penile Length
Evaluate compliance with therapy as a predictor of penile length changes during the study. A daily diary will be maintained by the patient to track actual device utilization. Patients will record how many minutes that they used the device daily. This information will be used to try to correlate penile length outcomes with actual device utilization.
Time frame: 1 year
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Charitable Union for the Research and Education of Peyronie's Disease