List of Abbreviations
VAS — Visual Analog Scale for pain
ICD-10 – International Classification of Diseases 10th Revision
BXO — balanitis xerotica obliterans
PVR — post-void residual volume
PRP — platelet-rich plasma
DM — diabetes mellitus
LS — lichen sclerosus
GR — Grade of Recommendation
LoE — level of evidence
US — ultrasound
Terms and Definitions
Redundant prepuce – a condition characterized by excessive development of the foreskin, which may manifest as difficulty in exposing the glans penis.
Phimosis – a pathological condition manifested by difficulty or inability to expose the glans penis due to narrowing of the foreskin or the development of cicatricial changes.
Paraphimosis – a pathological condition manifested by entrapment of the glans penis by a narrowed and/or edematous foreskin; it can lead to necrosis of the glans and requires emergency medical care.
Balanitis – a pathological condition characterized by inflammation of the glans penis.
Balanoposthitis – a pathological condition characterized by inflammation of the glans penis and prepuce.
Functionally narrowed prepuce – a condition characterized by the inability to fully retract the glans with normal development of the foreskin.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Redundant prepuce, phimosis, and paraphimosis are abnormalities of the penile prepuce that can be observed in both children and adults. Phimosis is a pathological condition characterized by the difficulty or inability to retract the glans penis due to preputial narrowing or scarring. Phimosis can cause inflammatory lesions of the glans penis and prepuce (balanitis and balanoposthitis), as well as erectile dysfunction and infravesical obstruction. A complication of phimosis is paraphimosis, a pathological condition manifested by the entrapment of the glans penis by a narrowed and/or edematous prepuce located behind the corona glandis [1]. Due to the risk of glans necrosis, paraphimosis is classified as an emergency condition requiring prompt medical care [2].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
The prepuce covers the glans penis, providing protection, and consists of external and internal mucosal layers [3]. The prepuce is elastic and normally stretches freely when the glans penis is exposed.
During embryogenesis, the prepuce first appears at the 8th week of intrauterine development as an epithelial ridge; by the 16th week, the prepuce is fully formed and covers the glans penis. At the same time, the epithelium of the glans and prepuce are in contact with the formation of preputial adhesions. Even before birth, the process of separation of the glans and prepuce begins with the formation of small spaces that create the preputial sac [4]. In most newborn boys, it is impossible to fully uncover the glans from beneath the prepuce, a condition termed physiologically narrow prepuce, which, in the absence of recurrent balanoposthitis up to 3–5 years of age, does not require treatment. By this age, the adhesions between the glans penis and prepuce should disappear, the preputial ring should widen, and the glans should be freely exposed. If this does not occur, pathological phimosis (congenital, or primary) develops [4, 5]. In phimosis, exposure of the glans is difficult or impossible due to a non-stretchable prepuce, narrowing of the preputial orifice, and/or the presence of adhesions between the glans and the prepuce.
Acquired phimosis usually develops as a result of a local inflammatory process (recurrent balanitis or balanoposthitis) and may be caused by poor personal hygiene and microtrauma [6]. Frequent relapses of balanoposthitis can lead to the development of balanitis xerotica obliterans (BXO), a chronic inflammatory disease affecting the glans penis, prepuce, external meatus, and distal urethra, which is histologically identical to lichen sclerosus [4]. BXO can be a cause of phimosis and meatal stenosis [7], and potentially carries a precancerous risk of transformation into squamous cell neoplasia and the development of penile cancer in adulthood [8].
The results of a study conducted in Great Britain showed that in 31% of patients, phimosis was primary, and in 69%, acquired [9]. A significant risk factor for acquired phimosis is diabetes mellitus, which was detected in 32% of men with acquired phimosis [9]. The incidence of phimosis in patients with diabetes mellitus is 6.7 times higher than in the general male population [10]. It has also been revealed that phimosis may be the initial manifestation of persistent hyperglycemia [11]. In patients with type 2 diabetes mellitus, the use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) for 1 year is associated with a 2-fold increased risk of phimosis compared with the use of glucagon-like peptide-1 receptor agonists [12].
Paraphimosis is a complication of phimosis. In paraphimosis, the narrowed prepuce is displaced behind the glans penis into the coronal sulcus during sexual intercourse or masturbation. Paraphimosis can also develop as a result of uncovering the glans and displacing the prepuce behind it during medical manipulations on the penis and urethra (examination of the glans penis, urinary bladder catheterization, cystoscopy), hygienic care of the glans penis, or masturbation. If the prepuce is not returned over the glans penis after the procedure, edema develops, followed by constriction of the edematous prepuce. The constricting preputial ring impairs blood supply to the glans penis, disrupts lymphatic drainage, causes enlargement of the glans, and carries a risk of necrosis [1].
1.3 Epidemiology of the Disease or Condition
At birth, less than 5% of boys have full exposure of the glans penis from beneath the prepuce; this figure increases to 15% by 6 months, 50% by 1 year, 80% by 2 years, and approximately 90% by 3 years of life [13]. By 17 years of age, congenital phimosis is detected in less than 1% of adolescent males [14]. The prevalence of phimosis in adult men is estimated across a wide range from 0.5% to 13%. According to a systematic review conducted in 2019, the prevalence of phimosis in adults is 3.4% (95% CI: 1.8–6.6) [15].
Paraphimosis occurs in uncircumcised men. The results of a large epidemiological study showed that the incidence of paraphimosis over 20 years of follow-up was 3.5 cases per 1,000 men, with the peak incidence in the age groups of 10 to 14 years (7.3 cases per 1,000 individuals) and 80 to 84 years (7.8 cases per 1,000 individuals) [16].
1.4 Features of Coding the Disease or Condition
N47 – Redundant prepuce, phimosis, and paraphimosis
1.5 Classification of the disease or condition
Congenital (primary) and acquired (secondary) phimosis are distinguished. Acquired phimosis develops in adult men with a normally formed prepuce as a result of various diseases and traumatic factors that often lead to scarring.
Currently, there is no universally accepted classification of phimosis by severity.
M. Meuli et al. (1994) proposed distinguishing 4 grades of phimosis severity, evaluated in the flaccid state of the penis: Grade I – fully retractable prepuce with a compressing ring on the penile shaft; Grade II – partial exposure of the glans; Grade III – visualization limited to the meatus; Grade IV – inability to retract the prepuce [17].
C.S. Kikiros et al. (1993) proposed distinguishing 5 grades of phimosis severity, also evaluated in the flaccid state of the penis: Grade 0 – full retraction of the prepuce; Grade 1 – full retraction of the prepuce with narrowing observed behind the glans; Grade 2 – partial exposure of the glans, good visualization of the meatus; Grade 3 – partial retraction of the prepuce with a visible meatus; Grade 4 – minor exposure of the glans penis with inability to visualize the meatus; Grade 5 – complete immobility of the preputial sac [18].
N.D. Akhvlediani et al. (2022) proposed distinguishing "functional phimosis" in adults – narrowing of the prepuce that manifests only during erection and is absent in the flaccid state [19].
There are no universally accepted classifications of paraphimosis.
1.6 Clinical presentation of the disease or condition
Redundant prepuce may be accompanied by discomfort during physical activity, irritation of the preputial skin, and difficulty in performing hygiene procedures.
A patient with phimosis complains of difficulty or inability to uncover the glans penis, pain and discomfort when attempting to uncover the glans, pain during erection and sexual intercourse, itching, skin burning, dysuria, discharge from the preputial sac (if complicated by infection and balanoposthitis), and difficulty urinating.
In paraphimosis, the patient notes pain, enlargement, swelling, and edema of the glans penis. When taking the medical history, it is necessary to clarify what preceded the onset of paraphimosis: medical manipulations on the penis and urethra (e.g., catheterization, cystoscopy), sexual intercourse or masturbation, introduction of foreign bodies into the prepuce, previous difficulties in uncovering the glans penis, trauma to the external genitalia, and the frequency of hygiene care of the glans penis [1, 20].
2. Diagnostics, medical indications and contraindications for diagnostic methods
Diagnostic criteria.
The diagnosis is established on the basis of:
1) anamnesis data (trauma and inflammatory diseases of the prepuce, duration of complaints),
2) physical examination (inspection, palpation) of the male genitalia.
It is recommended to take the patient's complaints and medical history in order to determine treatment tactics:
- duration of symptom onset;
- presence of pain in the preputial region;
- history of inflammatory and dermatological diseases of the prepuce [4].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: diagnosis of redundant prepuce, phimosis, and paraphimosis is based on medical history and physical examination. Establishing a diagnosis after a physical examination generally presents no difficulties. In redundant prepuce, uncovering the glans is possible, but excess prepuce is visualized when closed. Phimosis is diagnosed when the prepuce cannot be retracted or is only partially retractable. Paraphimosis is diagnosed when, after retracting the prepuce behind the glans penis into the coronal sulcus, a constrictive (entrapping) ring forms, leading to edema of the glans penis.
2.1 Complaints and Anamnesis
Indicated in section 1.6.
2.2 Physical Examination
It is recommended that all patients presenting with complaints of redundant prepuce, difficulty or inability in exposing the glans penis, inability to retract the prepuce, edema, or pain in the glans penis undergo a physical examination in order to establish a diagnosis [4, 21].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
During the physical examination, an inspection of the penis is performed.
Redundant prepuce: the volume of the prepuce is greater than necessary to cover the glans penis, while attempts to expose the glans do not cause difficulty, pain, or discomfort.
In phimosis, the prepuce has a proboscis-like appearance. The degree of preputial narrowing is assessed, along with the absence/presence of inflammation, and attention is paid to the presence of fissures or scars. When balanoposthitis develops, redness of the prepuce is noted. Attempts to uncover the glans cause difficulty or are unsuccessful and accompanied by severe pain. During urination, characteristic ballooning of the preputial sac occurs, after which urine begins to flow in a thin stream or drops.
In paraphimosis, the glans penis is enlarged, edematous, cyanotic, and constricted at the corona glandis by a ring of edematous prepuce. A constricting ring formed by the edematous prepuce is identified. A potential complication of paraphimosis is necrosis of the glans penis.
It is recommended to perform a physical examination of the external genitalia in all men with hyperglycemia, diabetes mellitus, or those receiving long-term therapy with sodium-glucose cotransporter-2 inhibitors (SGLT2i) in order to detect phimosis due to the high risk of preputial scarring [10, 12].
GCR BLEL 3Grade of Recommendation B (Level of Evidence – 3)
It is recommended that all patients with suspected paraphimosis undergo differential diagnosis with penile trauma, penile cancer, balanitis and balanoposthitis, and edema of the penis and prepuce associated with heart failure or allergic reactions in order to determine management tactics [20].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: in phimosis, the glans penis is covered. In penile trauma, there is a relevant medical history, along with hematomas and abrasions on the penis and scrotum. In advanced stages of penile cancer, a tissue mass, often ulcerating, is identified in the region of the glans penis and urethra. Balanoposthitis is characterized by signs of an acute inflammatory process, hyperemia of the prepuce and glans, and discharge from the preputial sac and urethra. In penile edema, the glans is covered by edematous prepuce, and edema of the entire penis and scrotum is also noted.
2.3 Laboratory Diagnostics
It is recommended that patients diagnosed with redundant prepuce, phimosis, or paraphimosis undergo laboratory diagnostics when planning surgical treatment [4, 21].patients diagnosed with redundant prepuce, phimosis, or paraphimosis undergo laboratory diagnostics when planning surgical treatment [4, 21].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
It is recommended to test blood glucose levels in patients with acquired phimosis (A09.05.023) for the purpose of diagnosing diabetes mellitus due to the high probability of a causal relationship between these conditions [10, 12, 46].
LeRR CLoE 4Level of recommendation confidence C (level of evidence – 4)
2.4 Instrumental Diagnostics
Instrumental diagnostics for redundant prepuce, phimosis, and paraphimosis are generally not required.
To assess the condition of the urinary tract and identify urinary outflow obstruction caused by phimosis, it is advisable to perform an ultrasound of the kidneys and bladder with determination of post-void residual urine volume (A04.28.002.001, A04.28.002.005) [22, 23].
It is recommended that following preputial circumcision, the excised tissue be sent for histological pathoanatomical examination of the preputial biopsy (surgical) material to rule out penile cancer, lichen sclerosus, and other preputial diseases (A08.21.003) [3, 17, 46, 47].
LeRR CLoE 4Level of recommendation confidence C (level of evidence – 4)
2.5 Other Procedures
It is recommended not to resort to consultations with other specialists for the diagnosis of phimosis and paraphimosis. However, in the presence of comorbid conditions and complications, especially prior to surgical intervention, consultations with specialists may be required, including a cardiologist, endocrinologist, neurologist, allergist, dermatovenerologist, and other specialists [20, 24].
Leveled CLevel of Evidence C (Level of Certainty of Evidence – 5)
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
It is recommended to base the choice of treatment tactics for preputial disorders on the type of pathology, the severity of clinical manifestations, and the presence of complications [20]. Physiological phimosis does not require treatment in the absence of comorbid conditions.
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
3.1 Conservative Treatment
Conservative treatment of phimosis
Topical corticosteroids
It is recommended to perform conservative treatment of phimosis in adults using topical corticosteroids in the form of an ointment or cream (0.05–0.1% #betamethasone, #hydrocortisone, #triamcinolone, and others) for 4–8 weeks when there are no indications for surgical treatment. The use of corticosteroids for phimosis is more effective than placebo and manual preputial stretching [25, 26, 27].
GCR CLoE 3Grade of Recommendation C (Level of Evidence – 3)
Comments. The use of corticosteroids may lead to partial or complete resolution of phimosis, although long-term follow-up data are lacking [27]. The efficacy of topical corticosteroids depends on their correct application, which should be performed directly onto the constricted ring while gently retracting the foreskin. Similarly, after completion of corticosteroid treatment, recurrences should be prevented by continuing to expose the glans penis daily [28]. Although corticosteroid therapy can be effective, adverse effects may occur, including skin atrophy, telangiectasia, and immunosuppression [27].
Conservative treatment of paraphimosis
It is recommended as a conservative treatment for phimosis to perform bimanual repositioning of the foreskin over the glans penis using the index and middle fingers while holding the glans with the thumbs [1].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to apply prior local anesthesia: application of 2% lidocaine** gel or lidocaine + prilocaine cream to the skin of the penis [1, 29].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
It is recommended to compress the glans and the swollen, edematous foreskin for 10–15 minutes to reduce edema of the foreskin and the glans penis [1].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to use the "ice glove" method to reduce edema of the foreskin and the glans penis: for this, an anesthetic gel (ATC: G04BX, Other urological drugs) is applied to the glans penis and foreskin for 5 minutes. Ice water is poured into a rubber glove, tied into a knot to prevent leakage of the contents, and the penis is invaginated into the glove for 15 minutes [30].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
To reduce edema before manual reduction, it is recommended to use osmotic methods [1, 31, 32]. Osmotic methods involve applying substances with a high osmotic gradient to the edematous foreskin and penis. This causes fluid removal and reduction of edema. For this purpose, granulated sugar is generously applied to the affected glans and foreskin, or the penis is wrapped in gauze generously soaked with 20% #mannitol** solution and left for 30-45 min. [31, 32, 33].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
It is recommended to perform multiple punctures of the edematous constricting ring of the foreskin [34, 35].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
3.2. Surgical treatment
3.2.1. Surgical treatment of phimosis
Indications for surgical treatment of phimosis include lack of response to conservative treatment, recurrent balanoposthitis (in remission), condylomas, foreskin injuries, and impaired urine outflow [4, 36].
Contraindications to surgical treatment [4, 36]:
- anomalies of the penis and urethra (hypospadias, urethral epispadias, etc.);
- acute inflammatory diseases of the penis;
- bleeding tendency (thrombocytopenia, coagulopathy, hemophilia);
- comorbid diseases and conditions precluding surgery and/or anesthesia.
Circumcision
Circumcision is considered a simple surgical procedure, but the overall complication rate is 3.8% [36]. The most common complications of this intervention include bleeding, incomplete or excessive removal of the foreskin, and infection. The following severe but rare complications (0.2–0.6%) have been described in the literature: urethral fistulas, necrotizing fasciitis, lymphedema, partial penile amputation, and penile necrosis [37].
It is recommended to perform circumcision as the primary surgical treatment for phimosis [34, 37].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Circumcision can be performed using several techniques: the guillotine method, the sleeve resection method, the dorsal slit method, modified dorsal longitudinal guillotine plasty, and laser circumcision [20, 38].
The use of a laser in circumcision has several potential advantages: better hemostasis, faster postoperative wound healing, reduced pain intensity, and decreased local edema [39].
Comments: according to a meta-analysis, the use of laser in circumcision compared to the standard technique demonstrates a lower overall complication rate (OR 0.33, 95% CI 0.24-0.47, p <0.001), scarring (OR 0.09, 95% CI 0.02-0.41, p = 0.002), and poor cosmetic outcome (OR 0.09, 95% CI 0.05-0.15, p <0.001). No statistically significant differences were found in operative time, bleeding rate, infectious complications, and reoperation rate [40].
Laser-assisted circumcision is more effective compared to standard surgery.
Device-assisted circumcision
Over the past 20 years, devices for performing circumcision have been developed, becoming an alternative to standard surgical techniques [41]. These devices are based on crushing the foreskin along the intended tissue contact line while simultaneously achieving hemostasis [26]. The foreskin is then excised or allowed to slough off via ischemic necrosis. The wound edges are sutured, glued, or sometimes left intact. Currently, disposable circular devices are used that simultaneously act as cutting and stapling instruments: disposable circumcision stapler (from 10 to 34 mm), disposable circumcision anastomomat (from 10 to 30 mm).
Device-assisted circumcision is contraindicated in men with anatomical penile anomalies, paraphimosis, active genital infection, penile cancer, and lichen sclerosus [42].
Comments. Circumcision performed using device-assisted techniques, compared to standard surgical techniques, significantly reduces operative time, causes less severe pain on the first postoperative day, and is accompanied by a higher level of patient satisfaction [43, 44, 45].
It is recommended to choose the surgical technique for phimosis based on the surgeon's operational skills and the capabilities of the medical facility [38].
GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)
It is recommended to conduct a follow-up examination 4-6 weeks after surgical treatment [26].
GCR CLoE 3Grade of Recommendation C (Level of Evidence – 3)
3.2.2. Surgical treatment of paraphimosis
It is recommended to perform surgical treatment—incision of the constricting foreskin ring—if the aforementioned conservative measures are ineffective. Circumcision is recommended as the next stage of treatment after the condition of the foreskin and penile tissue has normalized [1].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
3.3 Other Treatment
It is recommended to perform hygiene procedures with retraction of the foreskin at least 2-3 times a week in all patients with redundant foreskin/phimosis if the glans can be uncovered [20].
LoR CGoE 4Level of Recommendation C (Level of Evidence – 4)
3.4. Prognosis
With timely treatment, the prognosis is favorable.
3.5. Nutritional therapy
not applicable / not provided.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Medical rehabilitation and sanatorium-resort treatment are not provided.
5. Prevention and Dispensary Observation
It is recommended to cover the glans penis with the foreskin after various manipulations involving uncovering the glans penis (urinary bladder catheterization, cystoscopy, etc.) [1, 20].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is not recommended to forcibly uncover the glans penis in case of foreskin stenosis [1, 20].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Dispensing follow-up is not provided.
6. Organization of Medical Care
Indications for hospitalization in a medical organization:
1) Inability to urinate independently caused by complete obliteration of the preputial ring is an indication for emergency hospitalization. In other cases, circumcision is performed electively.
2) Paraphimosis is an indication for emergency hospitalization.
Indications for patient discharge from a medical organization:
1) Surgical intervention performed – circumcision.
2) Elimination of the constricting foreskin ring and covering of the glans penis in paraphimosis.
3) Normalization of the patient's general condition.
7. Additional Information
None.
Criteria for Evaluating the Quality of Medical Care
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Appendix A1. Working Group Composition
Al-Shukri Salman Khasunovich - MD, Professor, Head of the Department of Urology, Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation (Head).
Al-Shukri Adel Salmanovich - MD, Professor, Head of Urological Department No. 1 (General and Emergency Urology) of the Research Center of Urology, Research Institute of Surgery and Emergency Medicine, Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation.
Amdiy Refat Eldarovich - MD, Professor of the Department of Urology, Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation.
Borovets Sergey Yuryevich - MD, Professor of the Department of Urology, Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation.
Kuzmin Igor Valentinovich - MD, Professor of the Department of Urology, Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation.
Maksimova Albina Vadimovna - Urologist, Assistant Professor of the Department of Urology, Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation.
Conflict of interest:
There is no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
Urologist
Surgeon
General Practitioner (Family Doctor)
Methods used for evidence collection/selection: electronic database search.
Description of methods used to assess the quality and strength of evidence: the evidence base for the recommendations includes publications from the Cochrane Library, EMBASE, MEDLINE, and PubMed databases.
Methods used to assess the quality and strength of evidence:
expert consensus;
assessment of significance in accordance with the rating scheme.
Methods used for evidence analysis:
reviews of published meta-analyses;
systematic reviews with evidence tables.
Description of methods used for evidence analysis
When selecting publications as potential sources of evidence, the methodology used in each study is examined to ensure its validity. The result of this examination affects the level of evidence assigned to the publication, which in turn affects the strength of the recommendations.
To minimize potential bias, each study was evaluated independently. Any discrepancies in evaluations were discussed by the full panel of authors. If a consensus could not be reached, an independent expert was involved.
Evidence tables: compiled by the authors of the clinical guidelines.
Methods used to formulate the recommendations:
expert consensus.
Good Practice Points (GPPs)
Recommended good clinical practice is based on the clinical experience of the authors of these guidelines.
Economic analysis
Cost analysis was not performed, and pharmacoeconomic publications were not analyzed.
Recommendation validation method
External expert review.
Internal expert review.
Description of the recommendation validation method
The draft of these recommendations was reviewed by independent experts who were primarily asked to comment on how comprehensible the interpretation of the evidence underlying the recommendations is.
All comments received from the experts were thoroughly systematized and discussed by the members of the working group (authors of the recommendations). Each item was discussed individually.
Consultation and peer review
The draft recommendations were reviewed by independent experts who were primarily asked to comment on the clarity and accuracy of the interpretation of the evidence base underlying the recommendations.
Working Group
For final editing and quality control, the recommendations were re-analyzed by the working group members, who concluded that all expert comments and feedback were accepted in full.
Table 1. Scale for assessing the levels of evidence (LE) for diagnostic methods (diagnostic interventions)
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Scale for assessing the levels of evidence (LE) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definition |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Scale for grading levels of recommendation certainty (LRC) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
Clinical Guidelines of the Russian Society of Urology.
Order of the Ministry of Health of the Russian Federation No. 907n dated November 12, 2012 "On Approval of the Procedure for Providing Medical Care to the Adult Population in the Profile 'Urology'" (as amended and supplemented).
Order of the Ministry of Health of the Russian Federation No. 103n dated February 28, 2019 "On Approval of the Procedure and Deadlines for the Development of Clinical Practice Guidelines, Their Revision, the Standard Form of Clinical Guidelines and Requirements for Their Structure, Composition, and Scientific Validity of Information Included in Clinical Guidelines".
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Phimosis is a congenital or acquired condition characterized by the narrowing of the foreskin lumen with difficulty or inability to uncover the glans penis. In boys under 5 years of age, phimosis is considered physiological and does not require treatment unless there are complications, primarily infectious and inflammatory. By this age, phimosis generally resolves spontaneously. Phimosis can occur in adulthood. Several factors increase the risk of its development. These include inflammation of the glans and foreskin, penile trauma, and diabetes mellitus. Patients with phimosis may experience impaired urine outflow up to urinary retention, pain during erection, and sometimes the inability to engage in sexual intercourse. Phimosis often develops against the background of inflammation of the glans and foreskin. To prevent phimosis, it is necessary to maintain hygiene and thoroughly wash the glans and foreskin with water and soap solution. Treatment of phimosis depends on its severity and the presence of complications. In some cases, phimosis resolves after conservative treatment, but most often surgical intervention—circular excision of the foreskin (circumcision)—must be performed.
Paraphimosis is an acute pathological condition in which the glans penis is compressed and entrapped by a narrowed prepuce that has retracted behind the coronal sulcus, increased in volume due to edema, formed a constricting ring, and cannot spontaneously return to its normal position. Paraphimosis may be a complication of phimosis—narrowing of the prepuce—or may occur when, following urological procedures (urethral catheterization, cystoscopy) and exposure of the glans, the prepuce remains behind the coronal sulcus of the glans penis. Other causes of paraphimosis include forced violent retraction of the prepuce, trauma to the glans and prepuce during sexual intercourse or masturbation, inflammation of the glans penis and prepuce, allergic reactions, and complications of sexually transmitted diseases. Signs of paraphimosis include sharp pain in the area of the glans penis, the presence of a constricting preputial ring behind the glans penis, edema and redness or even cyanosis of the glans penis, and the inability to spontaneously return the prepuce to its original position. If paraphimosis is left untreated, inflammation and necrosis of the tissues of the glans penis may develop.
If symptoms appear, you must consult a urologist immediately. Self-treatment is dangerous. Seeking medical attention as early as possible ensures successful treatment and prevents complications. The doctor will attempt to manually reduce the prepuce; if manual reduction is impossible, surgical treatment must be performed to eliminate the constricting preputial ring.
To prevent paraphimosis, it is necessary to avoid forced exposure of the glans penis, trauma to the penis during sexual intercourse or masturbation, and to cover the glans penis with the prepuce after medical procedures that exposed the glans penis. It is also necessary to maintain personal hygiene of the genitals, treat phimosis and inflammatory diseases in the urogenital area, and consult a doctor if there is pain or difficulty in exposing the glans penis.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not applicable within the scope of these clinical guidelines.