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NCT Number: NCT06065436

Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

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Key information

Conditions

Peyronie Disease Connective Tissue Diseases Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Penile Diseases Penile Induration Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Wyatt H Anians, CCRP

CONTACT

[email protected]

507-538-6151

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with PD
  • Palpable penile plaque
  • Dorsal, lateral, or dorsolateral penile curvature
  • Penile curvature > 30 degrees and < 90 degrees as measured using goniometer during objective curvature assessment
  • Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)
  • "Stable PD symptoms' defined as PD symptom duration > 6-months or stable symptoms > 3-months

Exclusion criteria

  • Prior intralesional injections or surgery for PD.
  • Severe baseline penile pain.
  • Moderate or severe baseline ED based on IIEF-EF domain.
  • History of low intensity shockwave therapy for sexual dysfunction (ED or PD).
  • Ventral (downward) or ventrolateral penile curvature.
  • Moderate or severe (grade 2/3) plaque calcification as determined by PDDU.
  • Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.

Treatment and study plan

Collagenase Clostridium Histolyticum

Drug

Total of 8 Intralesional injection (0.90 mg), administered as four separate injection series. Within each series, subjects will receive two injections, administered approximately 1-7 days apart.

Other names: Xiaflex

Storz Duolith LiSWT

Device

Single low intensity shockwave therapy consistent of 1,500 shocks at a rate of 120 shocks/minute and using a power setting of 0.09 mJ/mm2. These treatments will occur four separate times, before each of the four separate CCH injection series.

Primary outcomes

  1. Change in symptom bother

    Time frame: Baseline, 6 weeks

    Measured using the validated Peyronie's Disease Questionnaire (PDQ) subdomain symptom bother. Four questions to evaluate pain or discomfort during vaginal intercourse: responses include "not at all bothered", "a little bit bothered" , "moderately bothered", "very bothered", "extremely bothered"

  2. Change in penetrative sexual intercourse

    Time frame: Baseline, 6 weeks

    Measured using self-reported question: "Over the past 4 weeks: When you attempted intercourse, how often were you able to penetrate (enter) your partner?" Responses include "no sexual activity", "almost never or never" , "a few times (less than half the time)", "sometimes (about half the time)", "Most times (more than half the time)", "almost always or always.

  3. Surgical straightening intervention

    Time frame: 6 weeks

    Number of subjects to require surgical straightening

  4. Change in erectile function

    Time frame: Baseline, 6 weeks

    Measured using the International Index of erectile Function

  5. Change in Erectile Function Domain (IIEF-EF)

    Time frame: Baseline, 6 weeks

Study contacts

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

Wyatt H Anians, CCRP

CONTACT

[email protected]

507-538-6151

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2023
Registry last updated
Jan 7, 2026

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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