Erectile Dysfunction, Peyronie Disease
Conditions
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.
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptom bother | Baseline, 6 weeks | 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 |
| Change in penetrative sexual intercourse | Baseline, 6 weeks | 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. |
| Surgical straightening intervention | 6 weeks | Number of subjects to require surgical straightening |
| Change in erectile function | Baseline, 6 weeks | Measured using the International Index of erectile Function |
| Change in Erectile Function Domain (IIEF-EF) | Baseline, 6 weeks | — |
Countries
United States
Contacts
Primary ContactWyatt H Anians, CCRP
Outcome results
None listed