The clinical efficacy and safety of outside-in transobturator sling with additional paraurethral fixation - The prospective longitudinal study.

Stress urinary incontinence (SUI) is a common condition that affect 30-40% of women in their lifetime. Midurethral slings (MUS) either suprapubic or transobturator can be safely used in the surgical treatment of SUI. The aim of this study was to collect clinical long-term data regarding safety and performance of transobturator sling with an additional tape fixation in women with urinary incontinence. This prospective longitudinal study was conducted on a group of 2086 female patients diagnosed with stress urinary incontinence. Follow up visits where scheduled 6 weeks, 6 and 12 months after surgery followed by annual checking when possible. Patients underwent transobturator sling procedure from 01.01.2011 to 31.12.2021. All patients had a monofilament tape inserted at the mid-urethra using outside-in technique (TOT) with 2 absorbable sutures parallel to the urethra. Success of surgery was defined as lack of any leakage during cough stress test whereas the subjective cure rate was determined by Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). 87% of patients who were operated at least 10 years before assessment reported ICIQ -SF < 6. Main postoperative complications were storage symptoms - de novo urgency and voiding difficulties. TOT is safe and highly effective surgical treatment for (SUI) in a long-term observation.

Relugolix combination therapy in European women with symptomatic uterine fibroids: a subgroup analysis from the randomized phase 3 LIBERTY pivotal trials.

OBJECTIVE: In the 24-week, phase 3 LIBERTY 1 (L1) and LIBERTY 2 (L2) trials, relugolix combination therapy (relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethisterone acetate 0.5 mg)) reduced uterine fibroid (UF)-associated symptoms. This post hoc analysis assessed safety and efficacy of relugolix-CT in European women from L1/L2. METHODS: Premenopausal women (aged 18-50 years) with UF-associated heavy menstrual bleeding (HMB) were randomized 1:1:1 in L1 (N = 388) and L2 (N = 382) to relugolix-CT or placebo for 24 weeks, or delayed relugolix-CT (relugolix 40 mg then relugolix-CT; 12 weeks each). Primary endpoint: proportion of responders (menstrual blood loss (MBL) <80 mL and reduction of ≥50% from baseline MBL volume) over the last 35 days of treatment. Secondary endpoints: MBL volume, amenorrhea, UF-associated pain, symptom severity, distress related to bleeding and pelvic discomfort, health-related quality of life (HRQoL). Safety endpoints included adverse event (AE) reporting and bone mineral density (BMD) assessment. RESULTS: In European women from L1/L2 (N = 124, 16%), a significantly greater proportion of treatment responders was observed with relugolix-CT vs. placebo (85.4% vs. 19.1%, respectively; nominal p < .0001). There were statistically significant improvements with relugolix-CT vs. placebo for several secondary endpoints: reduction in MBL volume, amenorrhea rate, proportion achieving mild-to-no pain, reduction in symptom severity and distress from bleeding and pelvic discomfort, and improvement in HRQoL. Incidence of AEs and percentage changes in BMD from baseline to week 24 were similar for relugolix-CT and placebo. CONCLUSIONS: In European women with UF and HMB, once-daily relugolix-CT vs. placebo improved UF-associated symptoms and preserved BMD.

Efficacy of Fractional CO2 Laser Treatment for Genitourinary Syndrome of Menopause in Short-Term Evaluation-Preliminary Study.

The postmenopausal state covers 40% of modern women's lives and 50-70% of postmenopausal women report GSM symptoms such as vaginal dryness, itching, frequent inflammations, lack of elasticity, or dyspareunia. Consequently, a safe and effective method of treatment is crucial. In a group of 125 patients, a prospective observational study was performed. The aim was to evaluate the clinical effectiveness of fractional CO2 laser in the treatment of GSM symptoms using a protocol of three procedures in 6-week intervals. The vaginal pH, VHIS, VMI, FSFI, and treatment satisfaction questionnaire were used. The fractional CO2 laser treatment was effective in improving all the objective forms of evaluation: vaginal pH (from 5.61 ± 0.50 at the baseline up to 4.69 ± 0.21 in the 6-week follow-up after the third procedure); VHIS (12.02 ± 1.89 at the baseline vs. 21.50 ± 1.76); VMI (21.5 ± 5.66 vs. 48.4 ± 4.46). Similar results were obtained for FSFI: 12.79 ± 5.351 vs. 24.39 ± 2.733, where 79.77% of patients were highly satisfied. Fractional CO2 laser therapy increases the quality of life by having a beneficial effect on the sexual function of women with GSM symptoms. This effect is obtained by restoring the correct structure and proportions of the cellular composition of the vaginal epithelium. This positive effect was confirmed by both objective and subjective forms of evaluating GSM symptom severity.

Effects of topical dehydroepiandrosterone therapy in women after pelvic organ prolapse surgery.

OBJECTIVE: Pelvic organ prolapse (POP) occurs predominantly in postmenopausal women. Restoration of the proper estrogenization of vaginal mucosa is important in preoperative and postoperative treatment, increasing the effectiveness of this approach. The objective of this study was the development of intravaginal vaginal suppositories containing DHEA and comparison of the clinical effects of vaginal topical therapy with DHEA, estradiol, or antibiotic after POP surgery. METHOD: Nine types of vaginal suppositories containing 6.5 mg DHEA in different bases were prepared to find optimal formulation for the vaginal conditions. Ninety women referred for POP surgery were randomly assigned to one of three groups receiving topical treatment in the postoperative period (estradiol, DHEA, or antibiotic). On admission to hospital and during follow-up vaginal pH, vaginal maturation index and vaginal symptoms were assessed. RESULTS: Vaginal suppositories with the base made from polyethylene glycol 1,000 without surfactants characterized the highest percentage of the released DHEA. In women treated with topical estradiol or DHEA a significant decrease in the number of parabasal cells, increase in superficial and intermediate cells in the vaginal smears, decrease in vaginal pH, and reduction of vaginal symptoms were observed. CONCLUSIONS: The use of topical therapy with DHEA or the use of topical therapy with estradiol in the postoperative period were both shown to improve maturation index, vaginal pH, and vaginal symptoms. The benefits of topical therapy with DHEA after pelvic organ prolapse repair brings similar results as estradiol, without potential systemic exposure to increased concentrations of sex steroids above levels observed in postmenopausal women.

Outcome of transobturator sling for treatment of female stress urinary incontinence applied as a single procedure or concomitantly with pelvic organ prolapse surgery.

INTRODUCTION AND OBJECTIVE: The aim of the study was to check the safety and efficacy of transobturator tape (TOT) combined with various prolapse procedures. The results were compared with outcomes of sling performed as an alone surgery. Risk factors for TOT failure were also identified. MATERIAL AND METHODS: The study comprised 219 patients with sling alone (Group SUI) and 221 after TOT combined with concomitant prolapse surgery (Group POP/SUI). Medical records were carefully reviewed to obtain demographic and clinical data, details of surgery, including intra-and postoperative complications. RESULTS: Subjective cure rate was slightly, but statistically significantly, higher in POP/SUI group (89.6% vs 82.6%; ch2 = 4.44; p = 0.035). There was no significant difference in sling efficacy dependant of type of POP surgery. Post-operative urine retention was more frequent in POP/SUI group compared to SUI group (18.6% vs 3.2%; ch2 = 34.36; p < 0.001). Logistic regression showed that age, BMI and prolonged pos-operative urine retention are independent factors affecting TOT outcome. Age ≥65years and BMI ≥30kg,m2 more than doubled the risk of failure: OR 2.348, CI 95% (1.330-4.147); p = 0.003 and 2.030, (95% CI 1.148-3.587); p = 0.015; respectively. Interestingly, post-operative urine retention appeared to be a positive prognostic factor OR 0.145, (95% CI 0.019-1.097); p < 0.05. CONCLUSIONS: Subjective efficacy of TOT used concomitantly with POP procedures is slightly higher than TOT alone. Better sling outcomes can be expected both for POP procedures involving both the anterior and posterior compartments. Age and obesity are independent factors of TOT failure, whereas prolonged post-operative urine retention is a positive predictive factor of TOT success.

The Urogynecology Section of the Polish Society of Gynecologists and Obstetricians Guideline for the diagnostic assessment of stress urinary incontinence in women.

OBJECTIVES: The aim of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) was to develop an updated Guideline for the diagnostic assessment of stress urinary incontinence (SUI) in women. MATERIAL AND METHODS: Earlier PSGO guidelines and the literature about the diagnostic assessment of SUI, including current international guidelines, were reviewed. RESULTS: As in the earlier guidelines, the diagnostic process was subdivided into the initial and the specialized diagnostics. Patients who required specialized diagnostic testing were identified. Functional diagnostic tests, performed by physiotherapists, were included. Attention was paid to new diagnostic possibilities. CONCLUSIONS: Initial diagnostic assessment is sufficient to devise the optimal treatment plan in a number of patients. It also allows to identify which patients will require specialized diagnostics, whose scope is individually tailored to the patient needs and depends on symptom complexity, surgical history, treatment plan, experience of the physician, availability of the equipment, and cost-effectiveness ratio.

Femistina versus Canephron as a prevention of urinary tract infections after midurethral sling surgery - Non-inferiority study.

OBJECTIVE: Urinary tract infection (UTI) is relatively common post-operative complication following midurethral sling placement (MUS), even in cases where intraoperative antibiotic prophylaxis was given. The primary aim of this study was to investigate the non-inferiority of Femistina as compared with Canephron in reducing symptomatic UTI in first six months following surgery. STUDY DESIGN: A sample size of 144 patients per group was established, to provide at least 90% power to demonstrate the non-inferiority of phytodrug Femistina versus Canephron as a prevention of post-MUS urinary tract infection. RESULTS: Women suffering from stress urinary incontinence and mixed urinary incontinence (MUI) with predominant SUI symptoms as confirmed by urodymamics (n = 320) were randomized in a 1:1 ratio to Femistina (40 mg, oral, twice daily for 20 days) or Canephron (3 × 5 ml taken orally-three times daily for 4 weeks). Both groups were homogenous for age, type of operation (only TOT outside-in) and severity of illness as indicated by ICIQ-SF questionnaire. We found that symptoms of UTI were significantly lower in patients receiving Femistina. During first 6 months after surgery UTI was confirmed in only 10 patients receiving Femistina (6,25%) when compared to 25 (15,63%) subjects receiving Canephron, p < 0.007. CONCLUSION: Femistina is not inferior to Canephron in preventing lower urinary tract infection after midurethral sling surgery.

The State of Health and the Quality of Life in Women Suffering from Endometriosis.

Quality of life is related to good health, family relations, feeling of self-esteem, and ability to cope with difficult situations. Endometriosis is a chronic condition which affects different areas of life. The lack of satisfaction in everyday life is mainly due to constant pain. The process of adjusting to a life with illness is associated with negative emotions. The aim of the article is to review the current state of knowledge concerning the impact of social and medical factors on a population of women affected by endometriosis. Women with endometriosis have an impaired quality of life compared to the general female population. Psychological consequences of endometriosis include: depression, anxiety, powerlessness, guilt, self-directed violence, and deterioration of interpersonal relations. It may contribute to lower productivity at work and less satisfying intimate life. A multi-disciplinary, evidence-based care is needed. The disease can take away the ability to be physically active, obtain an education, work continuously, and interact with friends. Social support and cognitive-behavioral therapy are extremely important for healing.

Uretero-vaginal fistulas - clinical presentation, treatment and literature overview.

A uretero-vaginal fistula (UVF) describes an abnormal connection between the ureter and vagina causing urinary incontinence, frequent infection, and discomfort. Although UVF might be diagnosed after vaginal delivery, infertility treatment or pelvic radiation therapy, gynecological operations, especially total abdominal hysterectomy, remain the leading cause of ureteral injury and formation of UVF. Traditional ureteroneocystostomy was usually the treatment of choice in patients with UVF. Nevertheless, it is now frequently replaced by less invasive endoscopic and percutaneous procedures which are also highly effective and feasible. That is why, ureteral stenting became the first-line treatment in uncomplicated UVF. The aim of this review is to present clinical presentation of UVF and to assess the current state of knowledge about the diagnosis and management of uretero-vaginal fistula with special interest on minimally-invasive methods.

Urine Nerve Growth Factor May Not Be Useful as a Biomarker of Overactive Bladder in Patients with Pelvic Organ Prolapse.

(1) Background: Overactive bladder (OAB) symptoms are frequently present in women with pelvic organ prolapse (POP). Although urinary nerve growth factor (NGF) is a promising biomarker of OAB, little is known about its role in patients with OAB secondary to POP. The aim of the study was to evaluate urinary NGF levels in patients with POP involving the anterior vaginal wall and check if it may serve as a predicting factor for postoperative resolution of OAB symptoms. (2) Methods: Eighty-three Caucasian women included in the study were divided into three groups: pure OAB, one associated with POP (POP&OAB) and a control group composed of healthy volunteers. The urine NGF and creatinine were assessed with ELISA tests to calculate the NGF/creatinine ratio. (3) Results: The NGF/creatinine ratio was significantly higher in patients with pure OAB in comparison with other groups; however, it did not differ between the control group and the POP&OAB group. There was no correlation between NGF/creatinine ratio and age, menopausal status, BMI, parity or urodynamic findings. The NGF/creatinine ratio was not a prognostic factor for OAB symptoms' resolution after surgical treatment of POP. (4) Conclusions: Urinary NGF excretion is not increased in women with OAB secondary to POP; thus, it may not serve as an OAB biomarker in these patients.

Overactive bladder as a dysfunction of the autonomic nervous system - A narrative review.

Overactive bladder (OAB) is a common condition with increasing prevalence. However, its aetiology is not fully understood. The main symptoms are sudden urge to urinate, with or without incontinence; increased daytime frequency; and nocturia. OAB-like symptoms can be caused by a number of diseases, including urinary tract infections, neurologic and metabolic diseases, and neoplasms. The final diagnosis is made after excluding all the abovementioned factors. Autonomic nervous system (ANS) dysfunction has also been identified as a possible cause of so-called 'idiopathic OAB'. In order to check this hypothesis, many studies have measured ANS activity in patients with OAB by means of dynamic pupillometry, heart rate variability and sympathetic skin response. These non-invasive, fast and reliable tests assess ANS function - both sympathetic and parasympathetic - indirectly. ANS activity depends on many factors, such as age, gender, baseline level and a number of environmental stimuli. An imbalance between the sympathetic nervous system and the parasympathetic nervous system can lead to homeostatic disruption and the subsequent development of many diseases, including OAB. This narrative review summarizes the most important studies concerning the putative influence of the ANS on OAB symptoms.

Urogynecology Section of the Polish Society of Gynecologists and Obstetricians Guidelines on the management of recurrent pelvic organ prolapse.

OBJECTIVES: The aim of the publication was to present the Guideline of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) for the management of recurrent pelvic organ prolapse, based on the available literature, expert knowledge and opinion, as well as everyday practice. MATERIAL AND METHODS: In 2005, 2006 and 2010, the panel of PSGO experts published guidelines for the diagnosis and treatment of patients with lower urinary tract symptoms (LUTS). This publication presents an update of those recommendations and concerns recurrent POP treatment. MAIN CONCLUSION: The analysis of data revealed that sacrocolpopexy with the use of commercial sets or polypropylene hernia mesh is the method of choice for the surgical repair of recurrent vaginal vault prolapse. However, a significantly higher risk of surgical and postoperative complications after sacrocolpopexy, as compared to vaginal surgeries, should be considered when making treatment decisions. In other types of recurrent POP, the choice of surgery method should be tailored to the individual needs of each patient and may depend on the medical center.

Postoperative Prevention of Urinary Tract Infections in Patients after Urogynecological Surgeries-Nonantibiotic Herbal (Canephron) versus Antibiotic Prophylaxis (Fosfomycin Trometamol): A Parallel-Group, Randomized, Noninferiority Experimental Trial.

INTRODUCTION AND HYPOTHESIS: Urinary tract infections (UTIs) are one of the most common complications of urogynecological surgeries. The risk of UTIs is increased by the catheterization of the bladder, intraoperative cystoscopy, and urine retention after the procedure. Due to increasing antibiotic resistance, there is a need to search for new methods of postoperative UTI prevention. Canephron is a mixture of century herbs, lovage roots, and rosemary leaves with diuretic, spasmolytic, anti-inflammatory, antibacterial, and nephroprotective properties. The aim of this study is to demonstrate the noninferiority of Canephron versus antibiotic prophylaxis with fosfomycin trometamol (FT), based on the collective results of postoperative urine culture analyses. METHODS: One hundred and twenty-five female patients were randomized into two groups before undergoing urogynecological surgeries, including a control group (n = 67), which received one dose of 3 g of FT the day after the procedure, and a study group (n = 58), which received Canephron three times a day for 14 days, starting the day after the procedure. All the patients were assessed using the Acute Cystitis Symptom Score (ACSS). RESULTS: UTIs were observed in 6.4% of the patients. There was no statistically significant difference between the use of FT and Canephron in terms of UTIs (Chi^2 N-1 = 0.8837; p = ns). Additional factors, such as menopausal status and the type of procedure performed, increased the risk of developing a UTI. Factors such as the body mass index (BMI) and parity had no correlation. CONCLUSIONS: Canephron is noninferior to FT in the prevention of postoperative UTIs. The use of such a phytotherapeutic drug may help to decrease antibiotic consumption, which is closely connected to the growing trend of antibiotic resistance.

The Urogynecology Section of the Polish Society of Gynecologists and Obstetricians Guidelines for the diagnostic assessment of pelvic organ prolapse.

OBJECTIVES: The aim of the team appointed by the Board of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) was to develop this interdisciplinary Guideline for the diagnostic assessment of pelvic organ prolapse (POP) in women, based on the available literature, expert knowledge and opinion, as well as everyday practice. MATERIAL AND METHODS: A review of the literature, including current international guidelines and earlier PSGO recommendations (2010-2020) about POP, was conducted. RESULTS: The steps of the diagnostic assessment for patients with POP, subdivided into initial and specialized diagnostics, have been presented. Indications for specialized diagnostic assessment have also been listed. In case of surgical treatment, the patient may be referred solely based on the initial diagnostics or after certain elements of the specialized diagnostics have been completed. CONCLUSIONS: Due to inconclusive data, the scope of the diagnostic process for POP is individualized for each patient and depends on patient-reported symptoms, initial diagnostic findings, surgical history, management plan, availability of the equipment, and cost.

Urogynecology Section of the Polish Society of Gynecologists and Obstetricians guidelines on the management of stress urinary incontinence in women.

OBJECTIVES: The aim was to present an interdisciplinary Guideline of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) for the management of stress urinary incontinence (SUI). MATERIAL AND METHODS: A review of the literature, including current international guidelines and earlier recommendations of the PSGO Urogynecology Section, about the treatment of SUI was conducted. RESULTS: Management of SUI is presented. Four lines of therapy were identified: line 1 - the so-called 'conservative treatment', which should always be attempted, regardless of SUI symptom severity; line 2 - surgical intervention; lines 3 and 4 - reoperations after unsuccessful surgeries from line 2. The literature reports which provided supporting evidence for this Guideline, including the practical aspects, were discussed. CONCLUSIONS: A systematic review of the guidelines and an analysis of SUI management were conducted. The need for an individualized approach was emphasized.

Quality of Sexual Life after Native Tissue versus Polypropylene Mesh Augmented Pelvic Floor Reconstructive Surgery.

There are still controversies around reconstructive surgeries used in POP treatment. The aim of this study was to compare the QoSL after VNTR vs. TVM surgery due to POP via the use of PISQ-12 and FSFI questionnaires. The study included a group of 121 sexually active patients qualified for reconstructive surgery due to symptomatic POP, and 50 control. The average results of PISQ-12 before and after surgery were compared using the t-test. The significance of the mean differences in demographic groups was measured using the t-test for independent samples and one-way ANOVA. The results in the demographic groups were compared using the Mann-Whitney U test and the Kruskal-Wallis test. Fifty-eight women had VNTR, while 63 had TVM. Results of PISQ-12 revealed significant improvement in the sexual life after reconstructive surgery (27.24 vs. 32.43; p < 0.001, t = 8.48) both after VNTR and TVM. There were no significant differences in the assessment of the QoSL according to PISQ-12 and FSFI results between both analyzed groups of patients (PISQ-12: VNTR vs. TVM; t-test p = 0.19 and FSFI: VNTR vs. TVM; Mann-Whitney U test p = 0.54). VNTR is the treatment of choice in the case of uncomplicated primary POP.

Reliability of the Polish Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and Assessment of Sexual Function before and after Pelvic Organ Prolapse Reconstructive Surgery-A Prospective Study.

It is estimated that 31-44% of all patients with symptomatic POP and/or UI suffer from sexual dysfunction. We aimed to validate the PISQ-12 in pre-and postmenopausal women and to assess the sexual function before and after POP reconstructive surgery. One hundred and forty sexually active patients were hospitalized due to symptomatic POP and 50 healthy controls were enrolled into the study. The patients were asked to complete PISQ-12, the FSFI and Beck's depression scale questionnaires twice. The Cronbach's alpha (α) was used to estimate the internal consistency. The scores were compared using the Intraclass Correlation Coefficient (ICC). Improvement in the QoSL (quality of sexual life) was observed in each age group of women. Pre-menopausal patients' QoSL was much better, both before and after surgery (29.62 and 34.64 points, respectively). The correlation between questionnaires before surgery was 0.63, and after was -0.76. The α value for the PISQ-12 was 0.83 before the procedure and 0.80 afterwards. In all the groups, the test-retest reliability was good-ICC = 0.72. Vaginal reconstructive surgeries improve the QoSL. The only demographic factor influencing the QoSL was the menopausal status. The Polish version of the PISQ-12 is a reliable and responsive instrument for assessing the sexual function in patients with diagnosed POP and/or UI.

Impact of Hysterectomy on Quality of Life, Urinary Incontinence, Sexual Functions and Urethral Length.

The aim of the study was to evaluate the influence of different types of hysterectomy on UI symptoms, quality of life and sexual functions using dedicated questionnaires. We investigated a correlation between the urethral length (UL), UI symptoms and the length of the cervix (left after LSH and SH) with sexual functions. The study enrolled 500 consecutive women referred for hysterectomy: 121 underwent VH, 171 underwent LSH, 96 underwent SH, 68 underwent TAH, and 44 underwent TLH. The patients filled in the UI-specific questionnaires and FSFI before and 12 months after hysterectomy. The UL was measured by introital ultrasound before and 12 months after hysterectomy. Before surgery, 137 out of 399 (34.3%) patients had UI symptoms; afterwards, 139 (34.8%) indicated the same (p > 0.05). There was no statistically significant difference in the UL in the patients before and after the procedure, and the cervix length did not differ between patients after LSH and SH. When the entire investigated population was analyzed, a significant improvement of the QoL was found on the IIQ-7. Hysterectomy performed due to benign diseases has effects on UI regardless of the surgical technique used. The UI symptoms improved only in the patients after LSH. The UL measured 12 months after hysterectomy did not change.

The Urogynecology Section of the Polish Society of Gynecologists and Obstetricians Guideline on the use of urodynamic testing in gynecological practice.

OBJECTIVES: The aim was to present an interdisciplinary Guideline of the Urogynecology Section of the Polish Society of Gynecologists and Obstetricians (PSGO) for the use of urodynamics (UDS) in the diagnostic process of patients with lower urinary tract symptoms (LUTS) based on the available literature, expert knowledge, and everyday practice. MATERIAL AND METHODS: A review of the literature concerning the use of UDS in women, including current international guidelines and earlier recommendations of the PSGO Urogynecology Section, was conducted. RESULTS: Urodynamic testing allows to make the urodynamic diagnosis which, nevertheless, remains to be the preliminary diagnosis. Medical history, physical examination, and detailed analysis of the previous test results (laboratory, imaging, endoscopic) need to be taken into consideration before making the final diagnosis. Urodynamic testing before surgical treatment of SUI is allowable, but the decision remains at the discretion of the physician. Urodynamic testing is not necessary before primary surgical treatment of uncomplicated SUI, but it has been demonstrated to optimize the therapeutic methods in complicated SUI. The significance of UDS in the diagnostic process of patients with overactive bladder symptoms, voiding dysfunction, and bladder outlet obstruction was discussed. CONCLUSIONS: Urodynamic testing is a vital element of the urogynecological diagnostic process. The scope of UDS should reflect the individual needs and symptoms of each patient and be based on the current guidelines, expert knowledge and experience of the physician, indications, and eligibility, as well as additional test results of the affected patients. Due to formal and legal requirements, PSGO, in this Guideline, wishes to emphasize the need for an individualized approach to both, test performance and result interpretation.