Treatment Summary

Background on this section

This section is outlined to provide a high-level, summary overview of our interpretation of the current scientific literature.  Please note that these recommendations are based on our opinions alone and do not represent those of any other society.  Also, please recognize that as Dr. Landon Trost is the inventor of the technology behind RestoreX, and even though we attempt to be completely unbiased, this should be recognized.  Near the end of this page, we additionally provide statements and recommendations that have been provided by the most relevant societies.  

Suggested Algorithm for Treatment

Men with Erectile Dysfunction

Unresponsive or unsatisfactory response to PDE5s or ICI

Recommendations:

    1. Placement of penile prosthesis
    2. At the time of prosthesis, use of adjunctive maneuvers (manual modeling, incision, possible grafting)

 

Optional:

    1. Use of vacuum erection device

 

Recommend Against:

    1. Shockwave therapy
    2. Platelet rich plasma
    3. Stem cell therapy

 

Reason for Recommendation:

It is widely recognized and accepted that men with erectile dysfunction that is unreponsive to medical therapies should undergo placement of a penile prosthesis.  There is debate as to whether penile prostheses should be considered even among men who are satisfied with PDE5s or ICI.  However, it is our opinion that surgery should never be considered first line (given its permanence and potential for side effects) if a viable conservative option is available.  Hence, if a man is satisfied with PDE5s or ICI therapies, he should be considered for non-surgical curvature correction options.

Men in the Early Phase of Disease

Preserved erectile function

Recommendations:

    1. Penile traction therapy (limits extent of worsening of disease)

 

Optional:

    1. Xiaflex (to correct curvature)
    2. Interferon (milder improvement in curvature; improves pain faster)
    3. Verapamil (likely least effective compared to Xiaflex or Interferon, but an option)

 

Recommend Against:

    1. Surgery
    2. Shockwave therapy

 

No Opinion (inadequate data):

    1. Oral therapies
    2. Topical therapies
    3. Platelet rich plasma
    4. Stem cells

 

Reason for Recommendation:

Penile traction therapy has been shown to reduce the extent of final curvature and length loss among men in the early (ideally <3 months) phase of Peyronie's Disease.(1)  Xiaflex, interferon, verapamil, and others have not been shown to be more (or less) effective in the early or late phase of disease, and hence these are optional treatments.  Oral therapies do not have enough consistent data available to suggest that they "should" be administered in men in the early phase of disease.

References: (1) Martinez-salamanca JI, et al: 2014 J Sex Med

Men in the Chronic Phase of Disease

Preserved erectile function

Recommendations:

    1. Xiaflex + RestoreX + Sildenafil qhs

 

Optional:

    1. RestoreX alone
    2. Surgery (plication or incision/excision and grafting depending on severity)
    3. Interferon (milder improvement in curvature; improves pain faster)
    4. Verapamil (likely least effective compared to Xiaflex or Interferon, but an option)

 

Recommend Against:

    1. Shockwave therapy
    2. Oral therapies
    3. Topical therapies
    4. Intralesional steroids

 

No Opinion (inadequate data):

    1. Platelet rich plasma
    2. Stem cells

 

Reason for Recommendation

Xiaflex + RestoreX has demonstrated the greatest improvements in length and curvature of any conservative therapy.(1)  Xiaflex + sildenafil has also demonstrated greater improvements compared to Xiaflex alone.(2)  There are essentially no long-term or permanent side effects which have been published with these conservative therapies, and our group has shown that the majority of men who use them ultimately never end up requiring surgery.(3)  Hence, these represent an optimal, first-line therapy.  If they are ultimately unsuccessful, surgery represents a viable 2nd-line option.

References: (1) Alom M, et al: 2019 J Sex Med; (2) Cocci A, et al: 2018 J Sex Med (3) Ziegelmann M, et al: 2016 J Urol

PDE5 = Phosphodiesterase 5 inhibitors (e.g. Viagra, Levitra, Cialis, Stendra); ICI = Intracavernosal injection therapies (e.g. Alprostadil, Caverject, Edex, Trimix, Bimix)

Summary of Scores / Recommendations

The following recommendation are based off of several assumptions: 30 degree curvature or more, bother associated with the disease, and a desire to treat

Oral Therapies

Therapy
Carnitine Recommend Against Recommend Against
Coenzyme Q Inadequate Data - Unclear efficacy; minimal side effects Inadequate Data - Unclear efficacy; minimal side effects
Colchicine Inadequate Data - Unclear efficacy or if benefits outweigh risks Inadequate Data - Unclear efficacy or if benefits outweigh risks
Omega-3 Fatty Acids Inadequate Data - Unclear efficacy Inadequate Data - Unclear efficacy
PDE5's (Viagra, Cialis, Levitra, Stendra) Option - Few risks; possible benefits Inadequate Data - Unclear efficacy
Pentoxifylline Inadequate Data - Unclear efficacy or if benefits outweigh risks Inadequate Data - Unclear efficacy or if benefits outweigh risks
POTABA Recommend Against Recommend Against
Tamoxifen Inadequate Data - Unclear efficacy Inadequate Data - Unclear efficacy
Vitamin E Recommend Against Recommend Against

Mechanical Therapies

Therapy
Penile Traction - 1st Generation (e.g. Andropenis, X4, Penimaster, Phallosan Forte) Option - Improves curve, length Option - Variable efficacy
Penile Traction - 2nd generation (e.g. RestoreX) Recommended 1st Line - Improves length, curve Recommended 1st Line - Improves length, curve, erectile function
Vacuum Erection Devices Option - 3rd best mechanical therapy Inadequate Data - Unclear if effective

Injection Therapies

Therapy
Collagenase clostridium histolyticum (Xiaflex) Option - Improves curve (best injection) Recommended 1st Line - Improves curve (best injection)
Interferon alpha-2b Option - Improves curve / pain (2nd best injection) Option - Improves curve (2nd best injection)
Verapamil Option - 3rd best injection Option - 3rd best injection

Surgical Therapies

Therapy
Penile Plication Recommend Against Recommended 2nd Line - Improves curve (decreases penile volume)
Incision/Excision and Grafting Recommend Against Recommended 2nd Line - Improves curve (worsens erectile function); for select candidates only
Penile Prosthesis Recommended 1st Line - For men with severe erectile dysfunction Recommended 1st Line - For men with severe erectile dysfunction

Published Guideline Statements

Last updated 2015 - currently undergoing updates / revisions - released soon after release of Xiaflex (limited Xiaflex data available at that point) and prior to release of 2nd generation traction devices (e.g. RestoreX)

Notes - This guideline is published by the leading society for Urologists and is performed in a rigorous manner.  

Diagnosis

1. Clinicians should engage in a diagnostic process to document the signs and symptoms that characterize Peyronie's disease. The minimum requirements for this examination are a careful history (to assess penile deformity, interference with intercourse, penile pain, and/or distress) and a physical exam of the genitalia (to assess for palpable abnormalities of the penis). (Clinical Principle)

2. Clinicians should perform an in-office intracavernosal injection (ICI) test with or without duplex Doppler ultrasound prior to invasive intervention. (Expert Opinion)

3. Clinicians should evaluate and treat a man with Peyronie's disease only when he/she has the experience and diagnostic tools to appropriately evaluate, counsel, and treat the condition. (Expert Opinion)

Treatment

4. Clinicians should discuss with patients the available treatment options and the known benefits and risks/burdens associated with each treatment. (Clinical Principle)

5. Clinicians may offer oral non-steroidal anti-inflammatory medications to the patient suffering from active Peyronie's disease who is in need of pain management. (Expert Opinion)

6. Clinicians should not offer oral therapy with vitamin E, tamoxifen, procarbazine, omega-3 fatty acids, or a combination of vitamin E with L-carnitine. [Moderate Recommendation; Evidence Strength Grade B(vitamin E/omega-3 fatty acids/Vitamin E + propionyl-L-carnitine )/ C( tamoxifen/procarbazine)]

7. Clinicians should not offer electromotive therapy with verapamil. (Moderate Recommendation; Evidence Strength Grade C)

8. Clinicians may administer intralesional collagenase clostridium histolyticum in combination with modeling by the clinician and by the patient for the reduction of penile curvature in patients with stable Peyronie's disease, penile curvature >30° and <90°, and intact erectile function (with or without the use of medications). (Moderate Recommendation; Evidence Strength Grade B)

9. Clinicians should counsel patients with Peyronie's disease prior to beginning treatment with intralesional collagenase regarding potential occurrence of adverse events, including penile ecchymosis, swelling, pain, and corporal rupture. (Clinical Principle)

10. Clinicians may administer intralesional interferon α-2b in patients with Peyronie's disease. (Moderate Recommendation; Evidence Strength Grade C)

11. Clinicians should counsel patients with Peyronie's disease prior to beginning treatment with intralesional interferon a-2b about potential adverse events, including sinusitis, flu-like symptoms, and minor penile swelling. (Clinical Principle)

12. Clinicians may offer intralesional verapamil for the treatment of patients with Peyronie's disease. (Conditional Recommendation; Evidence Strength Grade C)

13. Clinicians should counsel patients with Peyronie's disease prior to beginning treatment with intralesional verapamil about potential adverse events, including penile bruising, dizziness, nausea, and pain at the injection site. (Clinical Principle)

14. Clinicians should not use extracorporeal shock wave therapy (ESWT) for the reduction of penile curvature or plaque size. (Moderate Recommendation; Evidence Strength Grade B)

15. Clinicians may offer extracorporeal shock wave therapy (ESWT) to improve penile pain. (Conditional Recommendation; Evidence Strength Grade B)

16. Clinicians should not use radiotherapy (RT) to treat Peyronie's disease. (Moderate Recommendation; Evidence Strength Grade C)

17. Clinicians should assess patients as candidates for surgical reconstruction based on the presence of stable disease. (Clinical Principle)

18. Clinicians may offer tunical plication surgery to patients whose rigidity is adequate for coitus (with or without pharmacotherapy and/or vacuum device therapy) to improve penile curvature. (Moderate Recommendation; Evidence Strength Grade C)

19. Clinicians may offer plaque incision or excision and/or grafting to patients with deformities whose rigidity is adequate for coitus (with or without pharmacotherapy and/or vacuum device therapy) to improve penile curvature. (Moderate Recommendation; Evidence Strength Grade C)

20. Clinicians may offer penile prosthesis surgery to patients with Peyronie's disease with erectile dysfunction (ED) and/or penile deformity sufficient to prevent coitus despite pharmacotherapy and/or vacuum device therapy. (Moderate Recommendation; Evidence Strength Grade C)

21. Clinicians may perform adjunctive intra-operative procedures, such as modeling, plication or incision/grafting, when significant penile deformity persists after insertion of the penile prosthesis. (Moderate Recommendation; Evidence Strength Grade C)

22. Clinicians should use inflatable penile prosthesis for patients undergoing penile prosthetic surgery for the treatment of Peyronie's disease. (Expert Opinion)

Reference: https://www.auanet.org/guidelines/peyronies-disease-guideline

Last updated 2010 - prior to release of many contemporary therapies (Xiaflex, 2nd generation traction [e.g. RestoreX])

Notes - Specific guideline statements were not issued for Peyronie's Disease.  Below are our summaries from the 2010 J Sex Med Publication titled, "Summary of the Recommendations on Sexual Dysfunctions in Men."  

Evaluation

  1. A detailed history should be obtained focusing on onset, duration, pain, deformity, and presence of ED.
  2. Plaque measurement is inaccurate by any modality and is operator dependent - it is not a reliable assessment for treatment response.
  3. An assessment of curvature is best made by intracavernosal injection of a vasoactive agent.
  4. Duplex ultrasound is a useful but unnecessary test.

Treatment - Nonsurgical

  1. Men with early phase disease (<12 months) as well as those not psychologically ready for surgery are candidates for non-surgical therapy.
  2. Nonsurgical treatment has limited evidence for benefit.
  3. It is reasonable to consider electromotive drug administration, intralesional verapamil or interferon, and/or traction therapy.

Treatment - Surgical

  1. Gold-standard method for correcting deformity.
  2. Indicated for men with stable disease for >6 months, painless deformity, compromised ability to engage in coitus secondary to deformity, inadequate rigidity when there is extensive plaque calcification, and for those wanting the most rapid / reliable result.
  3. Should discuss risks of recurrent curvature, loss of erect length, diminished rigidity, and decreased sexual sensation.
  4. General agreement that for men with <60 degrees and adequate rigidity, tunical plication is preferred.  Those with more severe deformity (hourglass, >60 degrees) and good pre-operative rigidity, incision or partial excision and grafting is recommended.  Penile prosthesis is recommended when there is pre-op erectile dysfunction not responsive to PDE5 inhibitors (Viagra).  

Reference: Montorsi F, et al: 2010 J Sex Med

Last updated 2012 - prior to release of many contemporary therapies (Xiaflex, 2nd generation traction [e.g. RestoreX])

Notes - Specific guideline statements are included below

Congenital Penile Curvature

  1. Use Nesbit and other plication techniques for the treatment of congenital penile curvature in patients who undergo surgery. Strong Recommendation.

Diagnosis of Peyronie's Disease

  1. In the medical and sexual history of patients with Peyronie's disease, include duration of the disease, penile pain, change of penile deformity, difficulty in vaginal intromission due to deformity, and erectile dysfunction (ED).  Strong Recommendation
  2. In the physical examination, include assessment of palpable plaques, penile length, extent of curvature (self-photograph, vacuum-assisted erection test or pharmacological-induced erection) and any other possibly related diseases (Dupuytren's contracture, Ledderhose disease).  Strong Recommendation
  3. Do not use Peyronie's disease specific questionnaire in everyday clinical practice.  Weak Recommendation
  4. Do not use ultrasound (US) measurement of plaque size in everyday clinical practice.  Weak Recommendation
  5. Use Doppler US only in the case of diagnostic evaluation of ED, to ascertain vascular parameters associated with ED.  Weak Recommendation

Non-operative Treatment

  1. Use conservative treatment in patients not fit for surgery or when surgery is not acceptable to the patient.  Weak Recommendation
  2. Do not use extracorporeal shockwave treatment to improve penile curvature and reduce plaque size.  Weak Recommendation
  3. Use penile traction devices and vacuum devices to reduce penile deformity and increase penile length.  Weak Recommendation
  4. Do not use intralesional treatment with steroids to reduce penile curvature, plaque size or pain.  Weak Recommendation
  5. Do not use oral treatment with vitamin E and tamoxifen for significant reduction in penile curvature or plaque size.  Strong Recommendation
  6. Do not offer other oral treatments (acetyl esters of carnitine, pentoxifylline, colchicine) for the treatment of PD.  Weak Recommendation

Surgical Treatment

  1. Perform surgery only when Peyronie's disease (PD) has been stable for at least three months (without pain or deformity deterioration), which is usually the case after twelve months from the onset of symptoms, and intercourse is compromised due to deformity.  Strong Recommendation
  2. Prior to surgery, assess penile length, curvature severity, erectile function (including response to pharmacotherapy in case of erectile dysfunction (ED)) and patient expectations.  Strong Recommendation
  3. Use tunical shortening procedures, especially plication techniques as the first treatment option for congenital penile curvature and for PD with adequate penile length, curvature < 60° and absence of special deformities (hour-glass, hinge).  Strong Recommendation
  4. Use grafting techniques for patients with PD and normal erectile function, with no adequate penile length, curvature > 60º and presence of special deformities (hour-glass, hinge).  Strong Recommendation
  5. Use penile prosthesis implantation, with or without any additional procedure (modelling, plication or grafting), in PD patients with ED not responding to pharmacotherapy.  Strong Recommendation

Reference: https://uroweb.org/guideline/male-sexual-dysfunction/#3

*If you have noticed any important omissions from any section or strongly disagree with any of our recommendations, please email us at email@mfp.clinic with your evidence to support the differing opinion.  We are open to changing any of our opinions / recommendations but will only do so if it can be supported in the scientific literature.

Scroll to Top