CLINICAL TRIAL

Treatment for Penile Induration

Waitlist Available · 18+ · Male · Orem, UT

This study is evaluating whether a new injection may help treat Peyronie's disease.

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About the trial for Penile Induration

Eligible Conditions
Penile Induration · Peyronie's Disease

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Control Group 1
Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)
DRUG
+
RestoreX Penile Traction Device
DEVICE
Control Group 2
Penile Plication Surgery
PROCEDURE
+
Incision and Grafting (I&G) Surgery
PROCEDURE
+
RestoreX Penile Traction Device
DEVICE

Eligibility

This trial is for male patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Men with PD
>18 years old
Curvature ≥30 degrees
Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 5 primary outcomes and 8 secondary outcomes in patients with Penile Induration. Measurement will happen over the course of 1 year.

Hospitalizations
1 YEAR
Number of hospitalizations or ER visits resulting from treatment
1 YEAR
Peyronie's Disease Questionnaire (PDQ) Scores
1 YEAR
Comparison of PDQ questionnaire scores; Subdomains - psychological and physical (Q1-6; min/max 0-24; lower is better), penile pain (Q7-9; min/max 0-30; lower is better), symptom bother (Q10-15; min/max 0-16; lower is better)
1 YEAR
Objective measurements of penile length post treatment (compared to pre-treatment)
1 YEAR
Comparison of changes in penile length
1 YEAR
Penile Curvature
1 YEAR
Comparison of changes in penile curvature
1 YEAR
International Index of Erectile Function (IIEF) Scores
1 YEAR
Comparison of IIEF questionnaire scores-all domains except erectile function (which is a primary endpoint); subdomains: orgasmic function (Q9-10; min/max 0-10; higher is better), sexual desire (Q11-12; min/max 2-10; higher is better), intercourse satisfaction (Q6-8; min/max 0-15; higher is better), overall satisfaction (Q13-14; min/max 2-10; higher is better)
1 YEAR
Subjective reporting of changes in penile sensation post treatment
1 YEAR
Comparison of changes in penile sensation complication rates
1 YEAR
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does treatment usually treat?

There is an urgent need to increase the use of treatment in a greater number of cases, and to introduce new medical methods (mainly non-operative management).

Anonymous Patient Answer

What are common treatments for penile induration?

Patients with penile induration often describe the pain that occurs during intercourse as sharp and squeezing. Induration may occur at any age and can be caused by a number of different medical conditions. Patients and their physicians should consider a broad differential diagnosis that includes both sexual and nonsexual causes of painful penile lesions. Most cases of corporal fibrosis are not related to sexual activity, but can occur following circumcision or other procedures that involve irritation to the penis. The role of radiation therapy in inducing penile fibrosis remains ambiguous. A full range of treatments may be necessary to treat penile indurations if the pain fails to resolve with nonsurgical treatments.

Anonymous Patient Answer

What causes penile induration?

In this large cohort of men undergoing physical examination for erectile dysfunction, penile penile indurations were frequent (36.5%) but associated with significant psychological concerns (48%) only for men without a demonstrable diagnosis of erectile dysfunction. Further study is needed before establishing a definitive diagnosis of penile induration, and to address its treatment.

Anonymous Patient Answer

What are the signs of penile induration?

Signs of penile induration include an enlarged, firm, wrinkled penis and painful intercourse. Decreased sexual drive is another common symptom. However, induration can also be a symptom of a number of sexual-health issues. If penile size is of concern, a healthcare professional should be consulted.

Anonymous Patient Answer

How many people get penile induration a year in the United States?

Nearly 1 in 1 men in the United States has penile induration if they are age 37 or less, and nearly half of all men will display this symptom by age 46. Men with penile induration should still be evaluated for possible underlying conditions such as BPH so that any underlying disease is treated promptly and appropriately.

Anonymous Patient Answer

What is penile induration?

Penile induration is a pathological condition of the penile skin and is considered a sign of priapism. Because of its severity, the diagnosis may not be easily made and should be made with a higher degree of suspicion.

Anonymous Patient Answer

Can penile induration be cured?

Penile induration could be cured with repeated injections of corticosteroid. However, there was minimal resolution of underlying subcutaneous fatty involution. With proper therapy, most patients were symptom-free, with a good quality of life, and most were satisfied with the treatment achieved.

Anonymous Patient Answer

How does treatment work?

The authors suggest that the mechanism of action of the extract is related to the activation or inhibition of immune cells, specifically, the modulation of pro- and anti-inflammatory parameters in PBMC (lymphocytes and monocytes). Data from a recent study presented in this study support this theory of action.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

We were unable to find any other clinical trials of any type or any location related to small cell lung cancer management aside from clinical trials for SCLC.

Anonymous Patient Answer

What is treatment?

Induration resolves without any medication in 90 percent of the patients within 3 months of the initial diagnosis of condylomata acuminata. Treatment is therefore inappropriate due to its side effects and cost. It can be avoided.

Anonymous Patient Answer

Who should consider clinical trials for penile induration?

Penile induration should be investigated first and then assessed by a clinician who can manage the patient accordingly or the patient can choose to manage the condition by themselves. Clinical trials may not always be warranted and further investigation is required.

Anonymous Patient Answer

How serious can penile induration be?

In a penile transplant unit with an average of 20 reconstructive procedures per year, all cases of penile induration should be considered severe. In our opinion, the current surgical literature does not demonstrate the utility of routine use of a 'pouch cuff' in this setting, and more recent literature does not recommend routine use of any adjuvant mechanical devices after reconstruction. The incidence of serious complications is, however, considerable and appears to be greatest for reconstructions of large lesions and where a pre-operative'surgical' assessment has failed to exclude a non-penile-based diagnosis of impotence.

Anonymous Patient Answer
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