Peyronie Disease
Conditions
Keywords
collagenase clostridium histolyticum, curvature, Restorex, Xiaflex, traction, salvage
Brief summary
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.
Detailed description
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 * Medication administered on back-to-back days * Total of 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 performed ranging from 2-4 full-time and 2-4 part-time days to minimize bruising * Sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series. * 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 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. * This would be performed 9-12 months after the 4th series of injections. * The technique would be similar to the one noted above with the exception of more aggressive in-office modeling as described in our prior publication and per our ongoing randomized trial. * The men would receive up to two additional series per this protocol for a maximum number of cycles being 6 in total. 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.
Interventions
DRUGCollagenase Clostridium Histolyticum
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
DEVICERestoreX
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.
DRUGSildenafil
Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.
Sponsors
Charitable Union for the Research and Education of Peyronie's Disease
Endo USA Inc., a Keenova Therapeutics Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Investigators will be blinded to baseline curvature measurements.
Intervention model description
prospective, single-blinded clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * The patient exhibits a palpable plaque consistent with Peyronie's Disease * For partners, the only inclusion criteria is being willing to complete a questionnaire
Exclusion criteria
* Prior surgical treatment on the penis (other than circumcision) * Prior treatment with CCH injections * Any contraindications to CCH - as determined by the PI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penile Curvature | 1 year | 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 | 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penile curvature compared to more aggressive technique | 1 year | 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 | 1 year | 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 | 1 year | 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 | 1 year | 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. |
| Compliance with Therapy - Penile Curvature | 1 year | 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. |
| Satisfaction with therapy | 1 year | 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. |
| Penile length compared to more aggressive technique | 1 year | 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). |
| Penile length compared to our current salvage approach for CCH | 1 year | 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). |
| Compliance with Therapy - Penile Length | 1 year | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLandon Trost, MD
Charitable Union for the Research and Education of Peyronie's Disease
Outcome results
None listed