Changes

January 2023 — reviewed. A literature search was conducted in December 2022 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. No major changes to the recommendations have been made.

Update

Goals

To support primary healthcare professionals to:

• Make an accurate diagnosis of varicocele.
• Offer appropriate treatment in primary care.
• Refer to secondary care, or another specialist service, where necessary.
• Provide advice to men with varicocele.

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

NICE quality standards

What is a varicocele?

• A varicocele is a scrotal swelling consisting of a collection of dilated veins of the pampiniform plexus in the spermatic cord. It may be caused by incompetent or absent valves in the testicular (spermatic) vein or, rarely, may be secondary to a tumour or other pathological process obstructing the spermatic vein.
• Varicoceles are graded according to their size:
  • Sub-clinical — detected only by Doppler ultrasound.
  • Grade I (small) — palpable only with Valsalva manoeuvre.
  • Grade II (moderate) — palpable without Valsalva manoeuvre. 
  • Grade III (large) — visible through the scrotal skin.

[BMJ Best Practice, 2021; EAU, 2022b]

How common is varicocele?

• Varicoceles occur in 14% to 20% of males from adolescence onwards. 

[BMJ Best Practice, 2021; EAU, 2022b]

What causes varicocele?

• Varicoceles become apparent during adolescence, coincident with accelerated body growth and increased blood flow to the testes.
• The exact underlying mechanisms are not fully understood but are thought to include increased hydrostatic pressure in the left renal vein and incompetent or congenitally absent valves. Genetic factors may play a role.
• About 90% of varicoceles occur on the left side because of the difference in drainage routes of the right and left spermatic veins:
  • A varicocele drains into the spermatic vein within the inguinal canal on each side.
  • The left internal spermatic vein then drains vertically into the left renal vein at a right angle, and increased pressure in the vertical column of blood can lead to the dilation of the pampiniform plexus.
    • The left internal spermatic vein is also 8–10 cm longer, resulting in increased hydrostatic pressure.
  • The right internal spermatic vein drains at an oblique angle into the inferior vena cava, which gives it some protection.
  • Bilateral varicoceles (which occur in 10% of cases) may occur from cross-circulation from the left to right pampiniform plexus.

[BMJ Best Practice, 2021; EAU, 2022a; EAU, 2022b]

What are the risk factors for varicocele?

• The risk factors for varicocele include:
  • Being tall and lean, with lower body mass index (BMI) than age-matched controls.
  • Being underweight.
  • Family history of varicocele — especially in first degree relatives.

[BMJ Best Practice, 2021]

What are the complications?

Complications of varicocele include:

• Pain.
• Failure of ipsilateral testicular growth and development, hypogonadism.
  • Left testicular volume loss has been noted in 70% of adolescent males with grade II and III varicocele. In late adolescence, the contralateral right testis may also become smaller
• Fertility problems.
  • Clinically detectable varicoceles can be associated with abnormal gonadotrophin levels, impaired spermatogenesis, and histological changes to sperm.
  • Approximately 20% of males diagnosed with varicocele will have fertility problems.
  • The incidence of varicocele among men with primary infertility is up to 44%.
  • Increased scrotal temperature, hypoxia, and reflux of toxic metabolites leading to testicular damage are possible underlying mechanisms.

[BMJ Best Practice, 2021; EAU, 2022a; EAU, 2022b]

What is the prognosis?

• Most varicoceles are asymptomatic, do not affect fertility, and do not require treatment.
• Varicocelectomy is overall associated with:
  • Reduced pain.
  • Improved semen parameters — although data regarding whether this translates to improved pregnancy rates are highly conflicting.
  • Improved testicular volume. 
• A greater degree of clinical improvement following varicocelectomy is associated with a higher grade of varicocele.

[EAU, 2022a; EAU, 2022b]

What are the clinical features of varicocele?

• Suspect varicocele in adolescent boys, and men, if there is:
  • Painless scrotal swelling on the left side — 90% of varicoceles appear on the left and the remaining 10% are bilateral.
  • Scrotal or groin pain (uncommon) — fewer than 3% of men with varicocele have pain, dragging, or heavy sensations in the scrotum.
• Typical presentation of a 'bag of worms' within the spermatic cord above the testis on the left side of the scrotum:
  • The scrotum on the side of the varicocele may be seen to hang lower than on the normal side.
  • Dilation and tortuosity of the veins are increased on standing and are usually decreased when the man lies down. The varicocele cannot usually be palpated lying down.
  • Performing the Valsalva manoeuvre whilst standing increases dilation.
  • There may be a cough impulse.
• Small testis — larger varicoceles are associated with a higher incidence of testicular growth arrest in adolescents.
  • Surgical correction may reverse this.
• Infertility — approximately one in four men with abnormal semen parameters will have a varicocele, and approximately 40% of men with infertility have a varicocele.
• If there is uncertainty about the diagnosis, see the section on causes of scrotal swelling in the CKS topic on Scrotal pain and swelling.

How should I assess a man or boy with a suspected varicocele?

• For information on the assessment of a man or boy with scrotal swelling, see the section on assessment in the CKS topic on Scrotal pain and swelling.
• The diagnosis of varicocele is usually clinical.
  • Ultrasound with colour flow Doppler imaging may be useful if there is diagnostic uncertainty, or in larger men where thick scrotal skin or increased amounts of scrotal tissue may make examination difficult. 
• Examine all adolescents in the supine and standing positions to identify varicocele and assess whether testicular growth arrest has occurred.
  • If the testes are symmetrical, examine the boy annually through puberty and refer to a urologist if there is testicular asymmetry (left smaller than right) or impaired testicular growth.
• For men with varicocele, consider carrying out semen analyses and evaluation of serum follicle-stimulating hormone (FSH) and testosterone levels to assess testicular function.
  • Abnormal sperm production with an elevated FSH is consistent with impaired spermatogenesis.

Scenario: Management of varicocele

From age 10 years onwards (Male).

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of varicocele.

Search dates

April 2017 - December 2022

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

• exp varicocele/, varicocele.tw

Sources of guidelines

• National Institute for Health and Care Excellence (NICE)
• Scottish Intercollegiate Guidelines Network (SIGN)
• Royal College of Physicians
• Royal College of General Practitioners
• Royal College of Nursing
• NICE Evidence
• World Health Organization
• Guidelines International Network
• TRIP database
• Agency for Healthcare Research and Quality
• Institute for Clinical Systems Improvement
• National Health and Medical Research Council (Australia)
• Royal Australian College of General Practitioners
• British Columbia Medical Association
• Canadian Medical Association
• Alberta Medical Association
• Michigan Quality Improvement Consortium
• Singapore Ministry of Health
• National Resource for Infection Control
• RefHELP NHS Lothian Referral Guidelines
• Medline (with guideline filter)
• Driver and Vehicle Licensing Agency
• NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

• The Cochrane Library:
  • Systematic reviews
  • Protocols
  • Database of Abstracts of Reviews of Effects
• Medline (with systematic review filter)
• EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

• NIHR Health Technology Assessment programme
• The Cochrane Library:
  • NHS Economic Evaluations
  • Health Technology Assessments
• Canadian Agency for Drugs and Technologies in Health
• International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

• The Cochrane Library:
  • Central Register of Controlled Trials
• Medline (with randomized controlled trial filter)
• EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

• Bandolier
• Drug and Therapeutics Bulletin
• TRIP database
• Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

• Department of Health
• Health Management Information Consortium (HMIC)

Patient experiences

• Healthtalk
• BMJ - Patient Journeys

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

• British National Formulary (BNF)
• electronic Medicines Compendium (eMC)
• European Medicines Agency (EMEA)
• LactMed
• Medicines and Healthcare products Regulatory Agency (MHRA)
• REPROTOX
• Scottish Medicines Consortium
• Stockley's Drug Interactions
• TERIS
• TOXBASE
• Micromedex
• UK Medicines Information

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

• Clinical accuracy.
• Consistency with other providers of clinical knowledge for primary care.
• Accuracy of implementation of national guidance (in particular NICE guidelines).
• Usability.

Principles of the consultation process

• The process is inclusive and any individual may participate.
• To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
• Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
• Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
• External reviewers are not paid for commenting on the draft topics.
• Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
• All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
• All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

• Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
• Stakeholders identified from the following groups are invited to review draft topics:
  • Experts in the topic area.
  • Professional organizations and societies (for example, Royal Colleges).
  • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
  • Guideline development groups where the topic is an implementation of a guideline.
  • The British National Formulary team.
  • The editorial team that develop MeReC Publications.
• Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

• Topic selection
• Scoping of topic
• Selection of clinical scenarios
• First draft internal review
• Second draft internal review
• External review
• Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

• Animal studies
• Original research is not written in English

Possible exclusions for reviewed literature:

• Sample size too small or study underpowered
• Bias evident or promotional literature
• Population not relevant
• Intervention/treatment not relevant
• Outcomes not relevant
• Outcomes have no clear evidence of clinical effectiveness
• Setting not relevant
• Not relevant to UK
• Incorrect study type
• Review article
• Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

• Feasibility
  • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
• Organizational and Financial Impact Analysis
• Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
  • Eligible population
  • Current interventions
  • Likely uptake of new intervention or recommendation
  • Cost of the current or new intervention mix
  • Impact on other costs
  • Condition-related costs
  • In-direct costs and service impacts
  • Time dependencies
• Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

• Personal financial interests
• Personal family interest
• Personal non-financial interest
• Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.