Health TrialsbyHealthPanel

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

ConditionsPeyronie DiseaseErectile Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Collagenase Clostridium Histolyticum with Low Intensity Shockwave TherapyExperimental treatment 2 interventions
Group B: Collagenase Clostridium HistolyticumActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in symptom bother

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"

Time frame
Baseline, 6 weeks
2

Change in penetrative sexual intercourse

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.

Time frame
Baseline, 6 weeks
3

Surgical straightening intervention

Number of subjects to require surgical straightening

Time frame
6 weeks
4

Change in erectile function

Measured using the International Index of erectile Function

Time frame
Baseline, 6 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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