Recruiting

Shockwave Therapy

Sponsor:

Mayo Clinic

Code:

NCT06065436

Conditions

Peyronie Disease

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Collagenase Clostridium Histolyticum

Storz Duolith LiSWT

Study Details

Brief summary:

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.

Conditions

Peyronie Disease

Erectile Dysfunction

Study ID

NCT06065436

Start date

Jan 19, 2024

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).

active comparator: Collagenase Clostridium Histolyticum

Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.

Interventions

Collagenase Clostridium Histolyticum

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.

Storz Duolith LiSWT

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 outcome measure

  • Change in symptom bother [ Time Frame: Baseline, 6 weeks ]
  • Change in penetrative sexual intercourse [ Time Frame: Baseline, 6 weeks ]
  • Surgical straightening intervention [ Time Frame: 6 weeks ]
  • Change in erectile function [ Time Frame: Baseline, 6 weeks ]
  • Change in Erectile Function Domain (IIEF-EF) [ Time Frame: Baseline, 6 weeks ]

Central Contacts and Locations

Central contacts

Wyatt H Anians, CCRP

507-538-6151Anians.Wyatt@mayo.edu

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Wyatt H Anians, CCRP

507-538-6151Anians.Wyatt@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.