BridgeMD
New treatment option for Peyronie Disease
Official title Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
ClinicalTrials.gov ID: NCT06065436
What this study is testing
What is Collagenase Clostridium Histolyticum?
Collagenase Clostridium Histolyticum is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for peyronie disease.
Also referred to as Xiaflex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.