Consensus update on the therapeutic approach to patients with neurogenic detrusor overactivity.

INTRODUCTION AND OBJECTIVES: A Consensus document on the management of patients with neurogenic detrusor overactivity (NDO) was published in 2018. The present document aims to update its recommendations regarding treatment considering the new evidence available, and to contribute to the standardization of the management of this disorder. METHODS: The methodology used was based on a systematic review and the Nominal Group Technique. The clinical coordinator (CC) and the Consensus update group (CUG) defined the questions to be updated and carried out a systematic review to identify the new available evidence. After being evaluated by the expert panel, the relevant recommendations were updated and agreed in a consensus meeting. RESULTS: A total of 3210 publications were identified and 26 publications that met the inclusion criteria were included. The CUG updated 18 recommendations on the therapeutic approach to NDO. Unanimous consensus was reached on all of them. CONCLUSIONS: Previous recommendations need to be revised due to the availability of new drugs, the increasing evidence on the use of botulinum toxin or neuromodulation procedures, and new surgical options.

Complications of Synthetic Midurethral Slings: Is There a Relevant Discrepancy Between Observational Data and Clinical Trials?

CONTEXT: The complications of synthetic midurethral slings (MUSs) in women with stress urinary incontinence (SUI) have become a globally debated issue. OBJECTIVE: To systematically review the short- and long-term complications of mesh slings reported in observational data compared with clinical trial data, to determine whether the complication rates from clinical trials reflects "real-world" observational data. EVIDENCE ACQUISITION: PubMed and Cochrane Library were searched. Methods as detailed in Preferred Reporting Items for Systematic Reviews and Meta-analyses and Cochrane Handbook for Systematic Reviews of Interventions were followed. EVIDENCE SYNTHESIS: Thirty registries/databases including 709 335 MUS procedures (1-22 yr of follow-up) were identified. MUS procedures were associated with intraoperative bladder perforation in 0.86-3.6%, urethral perforation in 0-0.1%, vascular injury in 0.04-0.1%, voiding lower urinary tract symptoms (LUTS) in 1.47-3.5%, vaginal exposure in 0.2-1.9%, and reoperation in up to 9% of cases. Forty-three randomised clinical trials were identified, including 6284 women who underwent MUS procedures and 2177 women who underwent other interventions (1-10 yr of follow-up). MUS procedures were associated with urinary tract perforation in 2.58%, vaginal injury in 1.43%, de novo voiding LUTS in 4.37%, de novo storage LUTS in 5.41%, mesh extrusion/exposure (vaginal/urinary tract) in 2.54%, dyspareunia in 2.26%, pain (pelvic/suprapubic/perineal) in 2.83%, and reoperation for complications required in 1.82% of cases. Meta-analyses of the randomised controlled trials revealed that retropubic MUSs were associated with more events of urinary tract perforation (risk ratio [RR] 9.81, 95% confidence interval [CI] 5.05-19.04, high certainty of evidence [COE]) and voiding LUTS (RR 1.57, 95% CI 1.19-2.07, high COE) than transobturator MUSs. MUSs were associated with more events of pain than mini-slings (RR 1.72, 95% CI 1.04-2.87, moderate COE). CONCLUSIONS: Short- and long-term data on complications of polypropylene mesh used for female SUI are fairly comparable when using outcome data from well-designed clinical trials or from less structured prospective or retrospective registries. Comparisons have to be made with caution since the two systems of data collection are inherently incomparable. This knowledge should be incorporated in the discussion on how to implement polypropylene mesh for female stress incontinence. PATIENT SUMMARY: In order to know whether mesh tapes used for treating stress incontinence work well and are safe, high-quality information is important. It appears that well-designed clinical studies give similar results to large registration databases. These data should be interpreted with caution in view of the different ways the information was collected. These results will help physicians and patients understand the risks of mesh tapes.

Multimodal therapy in urachal carcinoma with oligometastatic bone disease.

A 35-year-old male patient was admitted to our hospital for urachal carcinoma with oligometastatic bone disease. He received a surgical resection through the umbilical area, urachal ligament and bladder dome (partial cystectomy) and adjuvant chemotherapy based on cisplatin-gemcitabine regimens together zoledronic acid with a good tolerance, no toxicity. Nine months after surgery, our patient presented no symptoms and the metastasis had been brought under control with no apparent signs of recurrence as assessed in a follow-up CT. To our knowledge, is the first case report of a urachal carcinoma with oligometastatic bone disease who received multimodal therapy, including surgery resection.

The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials.

PURPOSE: To understand how improvements in the symptoms of overactive bladder (OAB) seen with the ß3-adrenoceptor agonist mirabegron 50 mg, correlate with patient experience as measured by validated and standard patient-reported outcomes (PROs), and to identify whether there is overall directional consistency in the responsiveness of PROs to treatment effect. METHODS: In a post hoc analysis of pooled data from three randomized, double-blind, placebo-controlled, 12-week Phase III trials of mirabegron 50 mg once daily, responder rates for incontinence frequency (≥50 % reduction in incontinence episodes/24 h from baseline to final visit), micturition frequency (≤8 micturitions/24 h at final visit), and PROs [minimally important differences in patient perception of bladder condition (PPBC) and subsets of the overactive bladder questionnaire (OAB-q) measuring total health-related quality of life (HRQoL), and symptom bother] were evaluated individually and in combination. RESULTS: Mirabegron 50 mg demonstrated greater improvement from baseline to final visit than placebo for each of the responder analyses, whether for individual objective and subjective outcomes or combinations thereof. These improvements versus placebo were statistically significant for all double and triple responder analyses and for all single responder analyses except PPBC. PRO measurements showed directional consistency and significant correlations, and there were also significant correlations between objective and subjective measures of efficacy. CONCLUSIONS: The improvements in objective measures seen with mirabegron 50 mg translate into a meaningful clinical benefit as evident by the directional consistency seen in HRQoL measures of benefit.

Study of quality of life in patients with benign prostatic hyperplasia under treatment with silodosin.

OBJECTIVES: To assess the impact of urinary symptoms associated with benign prostatic hyperplasia and its treatment with silodosin, on quality of life (QoL) and sexual function, depending on age, severity of symptoms, time on treatment and prostate size. MATERIAL AND METHODS: A cross-sectional, observational study was conducted in 305 urology practices all around Spain. Socio-demographic and clinical data were collected and patients filled the following questionnaires: EQ-5D, Sexual Function Index (SFI) and International Prostate Symptom Score (IPSS). Multiple regression models were used to determine factors independently associated with patients' QoL. RESULTS: A total of 1,019 patients were enrolled, mean (SD) for: age 62.7 (5.7), EQ-5D 89.9 (13.9), sexual drive-SFI 3.71 (1.67), erection-SFI 6.11 (3.08), ejaculation-SFI 4.50 (2.06) problems-SFI 6.85 (3.37) and overall satisfaction-SFI 2.00 (0.99). The EQ-5D and SFI score were statistically lower with: older age, severe LUTS and greater prostate size (P<.01), but no differences were found related to time on treatment with silodosin. The EQ-5D score was positively associated with sexual satisfaction and desire size of SFI and the EQ-5D VAS score, and negatively with disability, semi-urban residence and comorbidities in the multiple regression analyses. CONCLUSIONS: Severe LUTS and older age are associated to a greater deterioration in sexual function and quality of life. However time on treatment with silodosin does not produce deterioration in the quality of life.

Urgency and pain in patients with overactive bladder and bladder pain syndrome. What are the differences?

BACKGROUND: The Overactive Bladder Syndrome (OAB) and the Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) are different urological conditions sharing 'urgency' as a common symptom. The aim of this review is to address our existing knowledge and establish how these symptoms are interrelated and to determine whether or not there is a common link between both symptoms complexes that help to distinguish one from the other. METHODS: Pubmed was used to obtain references for this non-systematic review aiming to discuss differences between OAB and BPS/IC. Guidelines of several professional associations and discussions based on expert opinion from the authors were implemented. RESULTS: Whilst in BPS the hallmark symptom is pain on bladder filling, urgency is the defining symptom of OAB. Whilst it is likely that the pain in BPS/IC arises from local inflammation in the bladder wall, the nature of urgency as a symptom, its origin, and the relationship between urgency and pain, as well as the different afferent mechanisms associated with the genesis of these sensory symptoms, remains unknown. Although the aetiology of both OAB and PBS/IC is unclear, the influence of environmental factors has been suggested. Both are chronic conditions with very variable symptom resolution and response to therapy. The relationship with voiding dysfunction, gynaecological causes of chronic pelvic pain or the possible alteration of the hypothalamic-pituitary-adrenal axis and psychological disorders has not been established. Inflammation has been suggested as the common link between OAB and BPS/IC. CONCLUSIONS: OAB and BPS/IC are different symptoms complexes that share urgency as a common symptom. None of them have a specific symptom although pain on bladder filling is the hallmark symptom in BPS/IC. Bladder pain with urgency should be a trigger for referral to the provider with appropriate knowledge and expertise in this disease state, whereas the management of OAB should be part of normal routine care in the community.

Assessment of the psychometric properties of the Spanish language version of questionnaire ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).

OBJECTIVES: To evaluate the psychometric properties of the Spanish version of the ICIQ-Male Lower Urinary Tract Symptoms Questionnaire (ICIQ-MLUTS): Feasibility (% of completion and ceiling/ground effects), reliability (Test-retest), convergent validity (vs Bladder Control Self-Assessment Questionnaire [BSAQ] and vs International Prostate Symptom Score [I-PSS]) and criterion validity (according to presence or absence of symptoms). MATERIAL AND METHODS: This was an observational, non-interventionist and multicenter study. 223 male patients with lower urinary tract symptoms (LUTS), predominantly storage symptoms and aged 18-65, took part in the study. Patients completed the ICIQ-MLUTS (test), I-PSS and BSAQ questionnaires and referred their urinary symptoms in a single visit, with the exception of a subgroup composed by 49 patients that completed the questionnaire again 15 days after initial visit to evaluate test-retest reliability. The questionnaire includes 13 items divided in 2 sub-scales: Voiding symptoms (V) from 0-20 and Incontinence symptoms (I) from 0-24. RESULTS: Percentage of patients that completed all items: 98.84%. Ground effect is 0 and ceiling effect was under 6% in both sub-scales. Test-retest reliability: Intraclass correlation coefficient (ICC) ranged from 0.68 to 0.88, except on Delay. Kappa shows a good agreement, between 0.60 and 0.81, except for Nocturia. Convergent validity: Correlation (Spearman) between the questionnaire sub-scales scores and the rest of measures is statistically significant (P < .01 and P < .05). Criterion validity: Statistically significant differences (P < .05) between scores on ICIQ-MLUTS, from patients that refer experiencing symptoms and those who do not. CONCLUSION: The Spanish version of the ICIQ-MLUTS questionnaire shows adequate feasibility, reliability and validity.

Evaluation of the impact of the urinary symptoms on quality of life of patients with painful bladder syndrome/chronic pelvic pain and radiation cystitis: EURCIS study.

OBJECTIVES: To evaluate the impact of urinary symptoms of Painful Bladder/Pelvic Pain Syndrome and Radiation Cystitis (PBCPPS) on the Quality of Life, and self-esteem of the patient. MATERIAL AND METHODS: An observational, multicenter, epidemiological and cross-sectional study was performed on patients with Painful Bladder/Chronic Pelvic Pain Syndrome and Radiation Cystitis. Data was recorded on severity of urinary symptoms and QoL impairment using the PUF Score. The patients evaluated the QoL deterioration grade through the King's Health Questionnaire (KHQ), and the level of their anxiety and self-esteem with the Goldberg's Anxiety Scale (GAS) and Rosenberg's Self-Esteem Scale (RSES), respectively. Post-hoc comparisons were performed between the results of the KHQ of this study and a sample of patients with urinary incontinence (UI). Results on RSES were analyzed with data from the general population and from patients with erectile dysfunction. RESULTS: A total of 530 cases, mostly female patients, who had been diagnosed with PBCPPS, were analyzed. High levels of deterioration in QoL were described: KHQ scores were significantly higher when compared with patients with UI (P<.01). Involvement of self-esteem was higher in patients with RC and men, who obtained scores similar to those of patients with erectile dysfunction. CONCLUSIONS: Patients with Painful Bladder Syndrome/Chronic Pelvic Pain Syndrome and Radiation Cystitis present high levels of anxiety, and significant reductions in both quality of life and self-esteem. Especially for men, this affectation is similar to that caused by erectile dysfunction.

[Benign prostatic hyperplasia and its treatment: impact on quality of life and sexual function]. / Hiperplasia benigna de próstata y su tratamiento: impacto en calidad de vida y función sexual.

OBJECTIVES: To evaluate the impact of benign prostatic hyperplasia (BPH) on health related quality of life (HRQoL) and sexual function, in patients with moderate-severe lower tract urinary symptoms (LUTS/BPH) under treatment with alpha-blockers; to study differences associated to age, urinary symptom severity and time under treatment. MATERIAL AND METHODS: 1580 patients diagnosed of BPH and LUTS/BPH, and in treatment with alpha-blockers were recruited in urology practices all around Spain. Socio-demographic- and clinic-data together with LUTS/HBP severity assessment (IPSS questionnaire) and responses to EQ-5D and the Sexual Function Index Questionnaire (SFI) were collected. A descriptive statistical analysis was performed, as well as test to contrast the results by age, LUTS/HBP severity and time under treatment; multiple linear regression models were adjusted for the answers to EQ-5D and SFI. RESULTS: Analysis database contained information of 1514 patients. Mean age (SD) was 63 (5.5) years (26.75% under 60 years), mean treatment time 1.8 (2.09) years (51.19% under one year). Mean questionnaire scores were: IPSS 17.29 (5.66) (65.85% moderate symptoms), EQ-5D 90 (14). The SFI-domains with worse scores were satisfaction and sexual drive. 52.58% of patients presented deteriorated HRQoL (IPSS-item 8). Age, symptom severity and time under treatment showed association with HRQoL and sexual function. CONCLUSIONS: BPH and its treatment impact negatively on HRQOL and sexual function, with a more pronounced deterioration in patients with severe LUTS/HBP, in older patients and in patients in treatment over a year.

[Impact of overactive bladder treatment on associated comorbidities]. / Impacto del tratamiento de la vejiga hiperactiva en las comorbilidades asociadas.

OBJECTIVES: To analyze the management of patients newly diagnosed with overactive bladder (OAB) and to assess the impact of treatment on associated comorbidities. MATERIAL AND METHODS: 1,434 patients over 60 years with newly diagnosed OAB and at least one associated comorbidity (urinary tract infections, genital skin infections, sleep disturbances, depression, and hypertension) were recruited in 300 urology/gynecology surgeries in Spain. In the first visit sociodemographic and clinic data were recorded, and treatment for OAB following usual practice was prescribed. 4-6 months later symptoms were reevaluated. A descriptive statistical analysis was performed, variables were compared by gender (Chi(2)/Mann-Whitney) and between visits (McNemar). RESULTS: Data for 1,274 valid patients in visit 1 and 1,153 in visit 2 are presented. Mean age in the sample was 68.17(6.19) years, 71.51% were women. 66.41% presented urgency, with or without urge urinary incontinence, and 33.59% presented urgency related to stress urinary incontinence. The most frequent associated pathologies were sleep disturbances (56.44%) and urinary tract infections (53.14%). Urinary tract infections and genital skin infections and treatment for depression were more frequent in women; sleep disturbances and hypertension in men. Treatments more frequently prescribed were anticholinergics (95.45%) and guidance for lifestyle changes (85.32%). Statistically significant improvement in symptoms of associated comorbidities was detected in visit 2. CONCLUSIONS: Detection and treatment of OAB symptoms is relevant to reduce both the impact of the affection and of associated pathologies.

[Second-line therapy of idiopathic detrusor overactivity. Sacral neuromodulation and botulinum toxin A]. / Second-line-Therapie der idiopathisch überaktiven Blase. Sakrale Neuromodulation und Botulinumtoxin A.

The syndrome of idiopathic overactive bladder (I-OAB) impairs quality of life for the affected individuals. Conservative treatment options such as antimuscarinics are not always effective, and resulting side effects can lead the patient to stop treatment. In recently years, minimally invasive and reversible sacral neuromodulation and botulinum toxin A have become available. Currently, the approved treatment option for I-OAB that is recommended by the International Consultation on Incontinence is sacral neuromodulation by InterStim therapy. This article gives an overview of the present clinical evidence on the effectiveness and reliability of these two treatment modalities as well as the current significance of sacral neuromodulation and botulinum toxin A for the second-line treatment of adult I-OAB.

[Update on the second line management of idiopathic overactive bladder]. / Le point sur les traitements de seconde ligne de l'hyperactivité vésicale idiopathique.

The overactive bladder syndrome (OAB) negatively affects the daily life of many people worldwide and conservative treatments, such as antimuscarinics, not always bring relief and/or are associated with considerable side effects resulting in treatment failure. Second line treatment options used to be invasive surgical procedures. However, less radical, minimally invasive and reversible alternatives, such as sacral neuromodulation and botulinum toxin A have emerged. Of these, only sacral neuromodulation with InterStim Therapy has been approved for OAB and been recommended by the International Consultation on Incontinence (ICI) in 2004. Nevertheless, depending of country rules and habits, both seem to be used by urologists in clinical practice for treating idiopathic OAB (I OAB). Therefore, this review attempts to provide an update on the available clinical evidence concerning the efficacy and safety, and the current position of sacral neuromodulation and botulinum toxin A in the second line management of adults with I OAB.

[Comparison between the "ICIQ-UI Short Form" Questionnaire and the "King's Health Questionnaire" as assessment tools of urinary incontinence among women]. / Comparación entre el cuestionario "ICIQ-UI Short Form" y el "King's Health Questionnaire" como instrumentos de evaluación de la incontinencia urinaria en mujeres.

INTRODUCTION: In our country there are a few available instruments to diagnose urinary incontinence (UI) from the patient's perspective. The King's Health Questionnaire (KHQ) and the "International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form" (ICIQ-UI SF) are the most widespread among that. The present study aimed to compare the clinical utility between KHQ and ICIQ-UI SF with regard to the urodynamic test. MATERIAL AND METHODS: Cross-sectional study performed in 116 women who completed the ICIQ-UI SF, the KHQ and the urodynamic test and were diagnosed according to each test. Sensibility and specificity values of symptom dimension of the ICIQ-UI SF and the KHQ were analyzed with regard to the urodynamic test. In addition, correlation scores between the both compared measures were calculated. RESULTS: Mean age (SD) of women was 54 years (SD = 13.99). KHQ and ICIQ-UI SF mean scores were 39.93 (22.11) and 13.76 (4.11), respectively. Correlation between both measures was moderated (r = 0.6; p < 0.001). Percentages of pts with symptoms suggesting Stress UI (SUI), Urge UI (UUI) and Mixed UI (MUI) according to each instrument were: 33.7, 17.3 & 49 (KHQ); 40.4, 15.4 & 44.2 (ICIQ-UI SF). Patients' distribution according to urodynamic test was: SUI 41.3%, UUI 20.2%, MUI 26.9% and 11.5% with other diagnosis. Sensibility and specificity values of both questionnaires were very similar, but feasibility was worse for the KHQ (7.76% of pts did not complete the questionnaire) than for the ICIQ-UI SF (2.59% did not complete the questionnaire). CONCLUSIONS: Because of its better feasibility, clinical use of ICIQ-UI SF is recommended against KHQ for UI evaluation.

Detrusor-sphincter dyssynergia.

Neurological control of micturition is undertaken by central and peripheral nerve systems through complex neuronal interconnections that are mediated by the action of several neurotransmitters, finally controlling the function of detrusor muscle and external urethral sphincter. In normal circumstances, both muscles must have co-ordinated contractions in such a way that when the detrusor contracts, the external urethral sphincter relaxes. The loss of this co-ordinated action leads to the so-called syndrome of detrusor-sphincter dyssynergia. Without adequate treatment, more than 50% of men with this condition will develop severe complications. There are several neurological diseases that might lead to this condition where a common physiopathology consists of a distortion of the complex neural mechanism innervating the lower urinary tract. Because of this complexity, it is difficult to find a curative treatment providing a definitive solution for a majority of patients. Although most of the currently available therapies only provide partial or temporary solutions, some modalities offer a promising perspective.

Persistence with antimuscarinic therapy in patients with overactive bladder.

Overactive bladder (OAB) is a chronic condition, which impacts patients' health and quality of life. The primary symptoms of OAB are distressing and may interfere with work, psychosocial and sexual functioning. OAB also is associated with increased risk of urinary tract infections, fractures from falls, skin infections and depression. Patient's concerns about the effects of incontinence on lifestyle highlight the need to restore continence. The mainstay of treatment is antimuscarinic drug therapy, which may often produce only modest reductions in OAB symptoms and may be accompanied by bothersome adverse effects, leading to poor adherence to prescribed medications. Successful treatment of OAB depends on persistence with the prescribed medication, and efficacy and tolerability are key influencers of persistence. New antimuscarinic agents are now available for treating OAB that significantly improve symptoms of incontinence, urgency and frequency with few adverse effects. An improved efficacy and tolerability profile should result in greater patient satisfaction and persistence with therapy during long-term therapy.

[SAFYRE. A new concept for adjustable minimally invasive sling for female urinary stress incontinence]. / SAFYRE. Un nuevo concepto de cabestrillo ajustable mínimamente invasivo para la incontinencia urinaria por estrés femenina.

INTRODUCTION: SAFYRE is a new readjustable and minimally invasive sling for the treatment of stress urinary incontinence (SUI). Attempts to restore the normal suburethral hammock using an anatomical approach have been made in recent years. The authors report their experience with this device, which associates the efficacy of slings with readjustability. MATERIAL AND METHODS: A total of 100 consecutive patients with clinical and urodynamic diagnosis of SUI underwent SAFYRE sling procedure. The age range was from 40 to 71, mean age 63 years. Seventy-five patients (75%) presented previous failed anti-incontinence procedures. Physical clinical examination, stress test, pad use and a urodynamic study were performed before the surgery. All the patients presented symptoms of SUI and 30% also reported mild urgency. RESULTS: The average follow up period was 14 months (12-30 months). The mean operative time was of 25 minutes. Dystopia repair was performed whenever necessary, during the same procedure. The average hospital stay was 24 hours. In 3% of the implants, bladder perforation occurred. During the postoperative period, 26 patients developed urgency symptoms. During that follow up period, 92% were found to be continent, 3% reported an improvement and 5% were dissatisfied. CONCLUSION: SAFYRE is a safe and quick procedure that allows for postoperative readjustment. This technique may be an attractive alternative if the good result obtained so far proves to be long lasting.