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

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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)

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

Trial contacts and locations

1

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Central trial contact

Wyatt H Anians, CCRP

Data sourced from clinicaltrials.gov

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