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Guideline Summary
Guideline Title
Guidelines on penile curvature.
Bibliographic Source(s)
Wespes E, Hatzimouratidis K, Eardley I, Guiliano F, Hatzichristou D, Moncada I, Salonia A, Vardi Y. Guidelines on penile curvature. Arnhem (The Netherlands): European Association of Urology (EAU); 2012 Feb. 24 p. [146 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Penile curvature

  • Congenital
  • Acquired (Peyronie's disease)
Guideline Category
Evaluation
Management
Treatment
Clinical Specialty
Internal Medicine
Surgery
Urology
Intended Users
Physicians
Guideline Objective(s)

To discuss and provide recommendations for penile curvature in the adult population

Target Population

Men with congenital or acquired penile curvature

Note: For paediatric congenital penile curvature, please refer to the National Guideline Clearinghouse (NGC) summary of the European Association of Urology (EAU) guideline Congenital penile curvature.

Interventions and Practices Considered

Assessment

  1. Medical and sexual history
  2. Physical examination
  3. Duplex ultrasonography

Management/Treatment

  1. Non-operative therapy
    • Potassium para-aminobenzoate
    • Intralesional treatment (verapamil, clostridial collagenase or interferon)
    • Topical verapamil gel
    • Iontophoresis with verapamil 5 mg and dexamethasone
    • Extracorporeal shock-wave treatment
    • Penile traction devices and vacuum devices
  2. Surgery
    • Tunical shortening procedures
    • Grafting techniques
    • Penile prosthesis implantation, with or without any additional procedure (modelling, plication or grafting)

Note: Intralesional treatment with steroids, oral treatment with vitamin E and tamoxifen, other oral treatments (acetyl esters of carnitine, pentoxifylline) were considered but not recommended.

Major Outcomes Considered
  • Penile deformity
  • Plaque size
  • Penile pain
  • Adverse effects of treatment

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

General Search Strategy

A structured literature search is performed for all guidelines but this search is limited to randomised controlled trials and meta-analyses, covering at least the past three years, or up until the date of the latest text update if this exceeds the three-year period. Other excellent sources to include are other high-level evidence, Cochrane review and available high-quality guidelines produced by other expert groups or organizations. If there are no high-level data available, the only option is to include lower-level data. The choice of literature is guided by the expertise and knowledge of the Guidelines Working Group.

Additional Methods for Guidelines on Penile Curvature

A systematic literature search of the Medline database was performed by panel members. The controlled vocabulary of the Medical Subject Headings (MeSH) database uses the specific term 'penile induration' for Peyronie's disease. There is no specific MeSH term for congenital penile curvature. In order to identify relevant articles, search included the MeSH terms 'congenital abnormalities', 'penis/*abnormalities' and 'male' as well as the free text term 'congenital penile curvature'. Since this is the first time guidelines on this topic are published, the search includes all relevant articles published up to January 2012. A total of 48 articles were identified for congenital penile curvature while this number was 1200 for Peyronie's disease. The panel reviewed all these records and selected the articles with the highest evidence available. However, in several subtopics only articles with low levels of evidence were available and discussed accordingly.

Number of Source Documents

1248

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Level of Evidence

1a Evidence obtained from meta-analysis of randomised trials

1b Evidence obtained from at least one randomised trial

2a Evidence obtained from at least one well-designed controlled study without randomisation

2b Evidence obtained from at least one other type of well-designed quasi-experimental study

3 Evidence obtained from well-designed non-experimental studies, such as comparative studies, correlation studies and case reports

4 Evidence obtained from expert committee reports or opinions or clinical experience of respected authorities

Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

General Methods Used to Formulate the Recommendations

  • The first step in the European Association of Urology (EAU) guidelines procedure is to define the main topic.
  • The second step is to establish a working group. The working groups comprise about 4-8 members, from several countries. Most of the working group members are academic urologists with a special interest in the topic. Specialists from other medical fields (radiotherapy, oncology, gynaecology, anaesthesiology, etc.) are included as full members of the working groups as needed. In general, general practitioners or patient representatives are not part of the working groups. Each member is appointed for a four-year period, renewable once. A chairman leads each group.
  • The third step is to collect and evaluate the underlying evidence from the published literature.
  • The fourth step is to structure and present the information. All main recommendations are summarized in boxes and the strength of the recommendation is clearly marked in three grades (A-C), depending on the evidence source upon which the recommendation is based. Every possible effort is made to make the linkage between the level of evidence and grade of recommendation as transparent as possible.

Specific Methods Used for This Guideline

It should be noted that when recommendations are graded (see the "Rating Scheme for the Strength of the Evidence" and "Rating Scheme for the Strength of the Recommendations" fields), there is not an automatic relationship between the level of evidence and the grade of recommendation. The availability of randomised controlled trials (RCTs) may not necessarily translate into a grade A recommendation if there are methodological limitations or disparities in the published results. Conversely, an absence of high-level evidence does not necessarily preclude a grade A recommendation if there is overwhelming clinical experience and consensus. In addition, there may be exceptional situations in which corroborating studies cannot be performed, perhaps for ethical or other reasons. In this case, unequivocal recommendations are considered helpful for the reader. Whenever this occurs, it has been clearly indicated in the text with an asterisk as 'upgraded based on panel consensus'. The quality of the underlying scientific evidence is a very important factor, but it has to be balanced against benefits and burdens, values and preferences and costs when a grade is assigned.

The aim of grading the recommendations is to provide transparency between the underlying evidence and the recommendation given.

Rating Scheme for the Strength of the Recommendations

Grade of Recommendation

  1. Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomised trial
  2. Based on well-conducted clinical studies, but without randomised clinical trials
  3. Made despite the absence of directly applicable clinical studies of good quality
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

The present Penile Curvature guidelines are a new publication that underwent a blinded peer-review process before publication.

Recommendations

Major Recommendations

Note from the European Association of Urology (EAU) and the National Guideline Clearinghouse (NGC): The following recommendations were current as of February 2012. However, because the EAU updates their guidelines frequently, users may wish to consult the EAU Web site for the most current version available.

Definitions for levels of evidence (1a-4) and grades of recommendation (A-C) are provided at the end of the "Major Recommendations" field.

Congenital Penile Curvature

Treatment

Conclusions

  • Medical and sexual history are usually sufficient to establish the diagnosis of congenital penile curvature. Physical examination during erection is useful for documentation of the curvature and exclusion of other pathologies (Level of evidence: 3).
  • Surgery is the only treatment option which can be performed at any time in adult life. Plication techniques have been used almost exclusively in isolated penile curvature with high curvature correction rates (Level of evidence: 3).

Peyronie's Disease

Epidemiology, Physiopathology and Natural History

Conclusions

  • Peyronie's disease is a connective tissue disorder, characterised by the formation of a fibrotic lesion or plaque in the tunica albuginea, which leads to penile deformity (Level of evidence: 2).
  • The contribution of associated comorbidities or risk factors (e.g., diabetes, hypertension, lipid abnormalities and Dupuytren's contracture) to the pathophysiology of Peyronie's disease is still unclear (Level of evidence: 3).
  • Two phases of the disease can be distinguished. The first phase is the acute inflammatory phase (painful erections, 'soft' nodule/plaque), and the second phase is the fibrotic/calcifying phase with formation of hard palpable plaques (disease stabilisation) Level of evidence: 2).
  • Spontaneous resolution is uncommon (3%-13%) and most patients experience disease progression (30%-50%) or stabilisation (47%-67%). Pain is usually present during the early stages of the disease but tends to resolve with time in 90% of men (Level of evidence: 2).

Patient Evaluation

Recommendations

  • Medical and sexual history in patients with Peyronie's disease must include duration of the disease, penile pain, change of penile deformity, difficulty in vaginal intromission due to deformity, and erectile dysfunction (Level of evidence: 2; Grade of recommendation: B).
  • Physical examination must include assessment of palpable nodules, 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) (Level of evidence: 2; Grade of recommendation: B).
  • Sonographic measurement of the plaque's size is inaccurate and operator dependent. It is not recommended in everyday clinical practice (Level of evidence: 3; Grade of recommendation: C).
  • Duplex ultrasonography is required to ascertain vascular parameters associated to erectile dysfunction (Level of evidence: 2; Grade of recommendation: B).

Non-operative Treatment

Recommendations

  • Conservative treatment for Peyronie's disease is primarily aimed at treating patients in the early stage of disease. It is an option in patients not fit for surgery or when surgery is not acceptable to the patient (Level of evidence: 3; Grade of recommendation: C).
  • Oral treatment with potassium para-aminobenzoate may result in a significant reduction in penile plaque size and penile pain as well as penile curvature stabilisation (Level of evidence: 1b; Grade of recommendation: B).
  • Intralesional treatment with verapamil may induce a significant reduction in penile curvature and plaque volume (Level of evidence: 1b; Grade of recommendation: C).
  • Intralesional treatment with clostridial collagenase showed significant decreases in the deviation angle, plaque width and plaque length (Level of evidence: 2b; Grade of recommendation: C).
  • Intralesional treatment with interferon may improve penile curvature, plaque size and density, and pain (Level of evidence: 1b; Grade of recommendation: B).
  • Topical verapamil gel 15% may improve penile curvature and plaque size (Level of evidence: 1b; Grade of recommendation: B).
  • Iontophoresis with verapamil 5 mg and dexamethasone 8 mg may improve penile curvature and plaque size (Level of evidence: 1b; Grade of recommendation: B).
  • Extracorporeal shock-wave treatment fails to improve penile curvature and plaque size, and should not be used with this intent but may be beneficial for penile pain (Level of evidence: 1b; Grade of recommendation: B).
  • Penile traction devices and vacuum devices may reduce penile deformity and increase penile length (Level of evidence: 3; Grade of recommendation: C).

Recommendations AGAINST

  • Intralesional treatment with steroids is not associated with significant reduction in penile curvature, plaque size or penile pain. Therefore intralesional treatment with steroids cannot be recommended (Level of evidence: 1b; Grade of recommendation: B).
  • Oral treatment with vitamin E and tamoxifen are not associated with significant reduction in penile curvature, plaque size or penile pain, thus, should not be used with this intent (Level of evidence: 2b; Grade of recommendation: B).
  • Other oral treatments (acetyl esters of carnitine, pentoxifylline) are not recommended (Level of evidence: 3; Grade of recommendation: C).

Surgical Treatment

Recommendations

  • Surgery is indicated when Peyronie's disease is stable for at least 3 months (without pain or deformity deterioration), which is usually the case after 12 months from the onset of symptoms and intercourse is compromised due to deformity (Level of evidence: 3; Grade of recommendation: C).
  • Penile length, curvature severity, erectile function (including response to pharmacotherapy in case of erectile dysfunction) and patient expectations must be assessed prior to surgery (Level of evidence: 3; Grade of recommendation: C).
  • Tunical shortening procedures, especially plication techniques are the first treatment options for congenital penile curvature and for Peyronie's disease with adequate penile length, curvature <60º and absence of special deformities (hour-glass, hinge) (Level of evidence: 2b; Grade of recommendation: B).
  • Grafting techniques are the preferred treatment option for patients with Peyronie's disease with no adequate penile length, curvature >60º and presence of special deformities (hourglass, hinge) (Level of evidence: 2b; Grade of recommendation: B).
  • Penile prosthesis implantation, with or without any additional procedure (modelling, plication or grafting), is recommended in Peyronie's disease patients with erectile dysfunction not responding to pharmacotherapy (Level of evidence: 2b; Grade of recommendation: B).

Definitions:

Level of Evidence

1a Evidence obtained from meta-analysis of randomised trials

1b Evidence obtained from at least one randomised trial

2a Evidence obtained from at least one well-designed controlled study without randomisation

2b Evidence obtained from at least one other type of well-designed quasi-experimental study

3 Evidence obtained from well-designed non-experimental studies, such as comparative studies, correlation studies and case reports

4 Evidence obtained from expert committee reports or opinions or clinical experience of respected authorities

Grade of Recommendation

  1. Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomised trial
  2. Based on well-conducted clinical studies, but without randomised clinical trials
  3. Made despite the absence of directly applicable clinical studies of good quality
Clinical Algorithm(s)

The original guideline document contains an algorithm for the treatment of Peyronie's disease.

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate management of penile curvature

Potential Harms

Non-operative Treatment

  • Potassium para-aminobenzoate may cause nausea, anorexia, pruritus, anxiety, chills, cold sweats, confusion, and difficulty in concentration, but no serious adverse events were reported.
  • Treatment-emergent adverse events with colchicine are gastrointestinal effects (nausea, vomiting, diarrhoea) that can be improved with dose escalation.
  • Side effects of verapamil are uncommon (4%) and minor including nausea, light-headedness, penile pain, and ecchymosis.
  • The most commonly reported side effects with clostridial collagenase were penile pain, contusions, and ecchymosis.
  • Side effects of interferon α-2b include myalgias, arthralgia, sinusitis, fever and flu-like symptoms. They can be effectively treated with non-steroidal anti-inflammatory drugs before interferon injection.
  • Adverse effects of steroids include tissue atrophy, thinning of the skin and immune suppression.

Surgical Treatment

Complications of surgery include penile shortening, erectile dysfunction, penile numbness, the risk of recurrent curvature, the potential for palpation of knots and stitches underneath the skin, and the potential need for circumcision at the time of surgery.

Qualifying Statements

Qualifying Statements
  • The aim of clinical guidelines is to help clinicians to make informed decisions about their patients. However, adherence to a guideline does not guarantee a successful outcome. Ultimately, healthcare professionals must make their own treatment decisions about care on a case-by case basis, after consultation with their patients, using their clinical judgment, knowledge, and expertise. A guideline is not intended to take the place of physician judgment in diagnosing and treatment of an individual patient.
  • Guidelines may not be complete or accurate. The European Association of Urology (EAU) and their Guidelines Office, and members of their boards, officers and employees disclaim all liability for the accuracy or completeness of a guideline, and disclaim all warranties, express or implied to their incorrect use.
  • Guidelines users always are urged to seek out newer information that might impact the diagnostic and treatment recommendations contained within a guideline.
  • Due to their unique nature – as international guidelines, the EAU Guidelines are not embedded within one distinct healthcare setting - variations in clinical settings, resources, or common patient characteristics, are not accounted for.

Implementation of the Guideline

Description of Implementation Strategy

The European Association of Urology (EAU) Guidelines long version (containing all EAU guidelines) is reprinted annually in one book. Each text is dated. This means that if the latest edition of the book is read, one will know that this is the most updated version available. The same text is also made available on a CD (with hyperlinks to PubMed for most references) and posted on the EAU website Uroweb (http://www.uroweb.org/guidelines/online-guidelines External Web Site Policy).

Condensed pocket versions, containing mainly flow-charts and summaries, are also printed annually. All these publications are distributed free of charge to all (more than 17,000) members of the Association. Abridged versions of the guidelines are published in European Urology as original papers. Furthermore, many important websites list links to the relevant EAU guidelines sections on the association websites and all, or individual, guidelines have been translated to some 25 languages.

Implementation Tools
Clinical Algorithm
Pocket Guide/Reference Cards
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness

Identifying Information and Availability

Bibliographic Source(s)
Wespes E, Hatzimouratidis K, Eardley I, Guiliano F, Hatzichristou D, Moncada I, Salonia A, Vardi Y. Guidelines on penile curvature. Arnhem (The Netherlands): European Association of Urology (EAU); 2012 Feb. 24 p. [146 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2012 Feb
Guideline Developer(s)
European Association of Urology - Medical Specialty Society
Source(s) of Funding

European Association of Urology

Guideline Committee

Penile Curvature Guidelines Writing Panel

Composition of Group That Authored the Guideline

Authors: E. Wespes (Chairman), K. Hatzimouratidis (Vice-chair), I. Eardley, F. Giuliano, D. Hatzichristou, I. Moncada, A. Salonia, Y. Vardi

Financial Disclosures/Conflicts of Interest

All members of the Penile Curvature guidelines writing panel have provided disclosure statements of all relationships they have that may be perceived as a potential source of conflict of interest. This information is kept on file in the European Association of Urology Central Office database and can be viewed online at the EAU Web site (http://www.uroweb.org/guidelines/eau-guidelines-board-and-working-panels/ External Web Site Policy). This guidelines document was developed with the financial support of the European Association of Urology (EAU). No external sources of funding and support have been involved. The EAU is a non-profit organisation and funding is limited to administrative assistance and travel and meeting expenses. No honoraria or other reimbursements have been provided.

The expert panel have submitted potential conflict of interest statements which can be viewed on the EAU website: http://www.uroweb.org/guidelines/online-guidelines/ External Web Site Policy.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the European Association of Urology Web site External Web Site Policy.

Availability of Companion Documents

The following are available:

  • Guidelines on penile curvature. Pocket guideline. Arnhem (The Netherlands): European Association of Urology; 2012 Feb. 9 p. Available in Portable Document Format (PDF) from the European Association of Urology (EAU) Web site External Web Site Policy.
  • EAU guidelines office template. Arnhem (The Netherlands): European Association of Urology (EAU); 2007. 4 p.
  • The European Association of Urology (EAU) guidelines methodology: a critical evaluation. Arnhem (The Netherlands): European Association of Urology (EAU); 2009. 6 p. Electronic copies: Available from the EAU Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on July 30, 2012. The information was verified by the guideline developer on August 19, 2012.

Copyright Statement

This summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Downloads are restricted to one download and print per user, no commercial usage or dissemination by third parties is allowed.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouseâ„¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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