RecruitingNot ApplicableNCT06065436

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

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

Sponsor

Mayo Clinic

Enrollment

60 participants

Start Date

Jan 19, 2024

Study Type

INTERVENTIONAL

Conditions

Erectile Dysfunction Peyronie Disease

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.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

• 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 Criteria7

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.

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Interventions

DRUGCollagenase 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.

DEVICEStorz 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.