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NCT Number: NCT06649539

Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

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.

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Key information

Conditions

Peyronie Disease Connective Tissue Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Penile Induration Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagenase Clostridium Histolyticum

Drug

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

Other names: Xiaflex, CCH

RestoreX

Device

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.

Sildenafil

Drug

Men will be prescribed sildenafil 25 mg nightly beginning treatment day 2 until 6 weeks after final injection of the final series.

Other names: Viagra

Primary outcomes

  1. Penile Curvature

    Time frame: 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.

  2. Penile Length

    Time frame: 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 outcomes

  1. Penile curvature compared to more aggressive technique

    Time frame: 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.

  2. Penile curvature compared to our current salvage approach for CCH

    Time frame: 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.

  3. Adverse Events

    Time frame: 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.

  4. Partner Support

    Time frame: 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.

  5. Compliance with Therapy - Penile Curvature

    Time frame: 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.

  6. Satisfaction with therapy

    Time frame: 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.

  7. Penile length compared to more aggressive technique

    Time frame: 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).

  8. Penile length compared to our current salvage approach for CCH

    Time frame: 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).

  9. Compliance with Therapy - Penile Length

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Holli Burgon

CONTACT

[email protected]

801-691-4714

Landon Trost, MD

CONTACT

[email protected]

801-655-0015

Sponsors and collaborators

Lead sponsor

Charitable Union for the Research and Education of Peyronie's Disease

Other

Collaborators

  • Endo USA Inc., a Keenova Therapeutics Company

Registry information

Official study title

Efficacy of a Step-wise Protocol in Optimizing CCH Outcomes in Men With Peyronie's Disease

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 18, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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