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

Mayo Clinic

Status: Enrolling

Conditions: Erectile Dysfunction; Peyronie Disease

Treatments: Device: Storz Duolith LiSWT; Drug: Collagenase Clostridium Histolyticum

Study type: Interventional

Funder types: Other

Identifiers

NCT06065436

23-002478

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy

Experimental group

Description:

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

Treatment:

Drug: Collagenase Clostridium Histolyticum

Device: Storz Duolith LiSWT

Collagenase Clostridium Histolyticum

Active Comparator group

Description:

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

Treatment:

Drug: Collagenase Clostridium Histolyticum