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Introduction: Bladder pain syndrome/interstitial cystitis (BPS/IC) is either Hunner lesion interstitial cystitis (HL IC) or non-Hunner lesion interstitial cystitis (N-HL IC), differing in the presence of HLs on cystoscopy. Cystoscopy is essential in diagnosing HL but are bladder biopsies useful in N-HL IC patients? Our objective was to assess bladder biopsy in patients with N-HL IC, evaluating whether the count of mast cells (MCs) and percentage of activated MCs could measure severity., Materials and Methods: This is a single-centre retrospective study., Inclusion Criteria: diagnosis of BPS/IC by ESSIC definition; absence of HLs. Each patient had three bladder biopsies., Statistical Analysis: χ2/Fischer's exact test; Wilcoxon signed-ranks test/Mann-Whitney U test. Statistical significance: p < 0.05., Results: We separated 48 women into Group 1 with <50% of MCs activated and Group 2 with >50%. We compared the results of the O'Leary-Sant questionnaire between the two groups and did not find any correlation between the severity of the pathology and either the MC count in the detrusor or the percentage of activated MCs in the lamina propria or detrusor., Discussion/conclusion: These findings cast doubt on the usefulness of bladder biopsy for the evaluation of severity in N-HL IC., (© 2022 S. Karger AG, Basel.)

Objectives: There is confusion about the terms of bladder pain syndrome (BPS) and Interstitial Cystitis (IC). The European Society for the Study of IC (ESSIC) classified these according to objective findings [9]. One phenotype, Hunner lesion disease (HLD or ESSIC 3C) differs markedly from other presentations. Therefore, the question was raised as to whether this is a separate condition or BPS subtype. Methods: An evaluation was made to explore if HLD differs from other BPS presentations regarding symptomatology, physical examination findings, laboratory tests, endoscopy, histopathology, natural history, epidemiology, prognosis and treatment outcomes. Results: Cystoscopy is the method of choice to identify Hunner lesions, histopathology the method to confirm it. You cannot distinguish between main forms of BPS by means of symptoms, physical examination or laboratory tests. Epidemiologic data are incomplete. HLD seems relatively uncommon, although more frequent in older patients than non-HLD. No indication has been presented of BPS and HLD as a continuum of conditions, one developing into the other. Conclusions: A paradigm shift in the understanding of BPS/IC is urgent. A highly topical issue is to separate HLD and BPS: treatment results and prognoses differ substantially. Since historically, IC was tantamount to Hunner lesions and interstitial inflammation in the bladder wall, still, a valid definition, the term IC should preferably be reserved for HLD patients. BPS is a symptom syndrome without specific objective findings and should be used for other patients fulfilling the ESSIC definitions.

Aims: To assess the efficacy of a micronized-palmitoylethanolamide-polydatin (m-PEA-Pol) based product on chronic pelvic pain and severity of other symptoms in interstitial cystitis/bladder pain syndrome (IC/BPS) patients refractory to conventional therapies., Methods: A pilot, open-label bicentric study was carried out involving 32 IC/BPS patients. Chronic, oral m-PEA-Pol treatment lasted 6 months. Bladder pain was evaluated using the visual analog scale, while changes from baseline in other urinary symptoms were evaluated by means of the O'Leary-Sant Interstitial Cystitis Symptom and Problem Index and the Pelvic Pain and Urgency/Frequency (PUF) symptom scale questionnaires. The generalized linear mixed model was used to evaluate significant mean changes across time., Results: A significant and progressive reduction of pain intensity was observed during m-PEA-Pol treatment ( p < 0.0001 for reduction over time). The effect was associated with a reduction in severity of patients' symptoms evaluated with the O'Leary-Sant questionnaire ( p =0.0110 and p =0.0014 for cystitis symptoms and problem mean scores, respectively) and the PUF scale ( p =0.0163 and p =0.0005 for symptom and bother mean scores, respectively). m-PEA-Pol therapy elicited a significant reduction over time in the urinary frequency evaluated with voiding diary ( p =0.0005) and a small but not significant improvement of bladder capacity., Conclusions: These data highlight the potential benefit of m-PEA-Pol in patients with rare pathology such as IC/BPS and confirm the good safety profile of micronized PEA-based products., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2019 M. Cervigni et al.)

Aims: To present a rationale for the inclusion of urothelial coating dysfunction in the etipathogenesis of bladder pain syndrome/interstitial cystitis (BPS/IC) and the preclinical and clinical evidence in support of glycosaminoglycan (GAG) replenishment therapy in the treatment of BPS/IC, supplemented by the clinical experience of medical experts in the field and patient advocates attending a symposium on GAG replenishment at ESSIC'17, the annual Meeting of the International Society for the Study of Bladder Pain Syndrome, held in Budapest, Hungary in 2017., Results: The urothelial GAG layer has a primary role in providing a permeability barrier to prevent penetration of urinary toxins and pathogens into the bladder wall. Disruption of the GAG layer contributes to the development of BPS/IC. The evidence shows that replenishment of GAGs can restore the GAG layer in BPS/IC, reducing inflammation, pain, and other symptoms., Conclusions: Although data from large randomized controlled studies are limited, long clinical observation and the experience of clinicians and patients support the beneficial effects of intravesical GAG replenishment therapy for providing symptomatic relief for patients with BPS/IC., (© 2018 Wiley Periodicals, Inc.)

Aims: To evaluate the efficacy, safety, and tolerability of repetitive Transcranial Magnetic Stimulation (rTMS) associated with standard drug therapies for neuropathic pain that does not respond to pharmacological treatment alone in patients with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). Secondary goals were to assess the effects of rTMS on Lower Urinary Tract Symptoms (LUTS) and Quality of Life (QOL)., Methods: Fifteen patients with BPS/IC were enrolled in this randomized, double-blind, sham stimulation-controlled, crossover study. Patients were treated for 2 weeks with either real-rTMS (for five consecutive days in 20-min sessions) or sham-rTMS (for five consecutive days in 20-min sessions). After a 6-week washout period, the patients who had previously undergone real-rTMS underwent sham-rTMS, and vice versa. Patients were rated at each visit by means of questionnaires on pain, urinary disturbances, depression, and QOL., Results: The statistical analysis revealed significant effects of real-rTMS, when compared with sham-rTMS, on pain (in the VAS, Functional Neuropathic Pelvic Pain, Neuropathic Pain Symptom Inventory, McGill questionnaire, and Central Sensitization Inventory), urinary LUTS (in the Overactive Bladder Questionnaire score, bladder emptying, and daily urinary frequency), and QOL (in the subscores of the SF-36 related to physical pain and to emotional status). No serious adverse events were reported during the study., Conclusions: The results of this study show that rTMS applied with an H-coil over the M1 in the area corresponding to the pelvic region in patients with BPS/IC appears to improve chronic pelvic pain (CPP) and associated urinary disorders., (© 2018 Wiley Periodicals, Inc.)

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a chronic bladder condition characterized by frequent urination, bladder inflammation and pain. It is a particular challenging disease and a clear unmet medical need in terms of identifying new therapeutic strategies. The aim of study was to evaluate the anti-inflammatory effects of intravesical Vessilen ® (a new formulation of 2% adelmidrol (the diethanolamide derivative of azelaic acid) + 0.1% sodium hyaluronate) administration in rodent models of IC/BPS and in IC/BPS patients or other bladder disorders. Acute and chronic animal models of cystitis were induced by a single or repetitive intraperitoneal injections of cyclophosphamide (CYP); patients with IC/BPS or with bladder pain syndrome associated with symptoms of the lower urinary tract treated once weekly by bladder instillation of Vessilen ® for 8 weeks. CYP instillation caused macroscopic and histological bladder alterations, inflammatory infiltrates, increased mast cell numbers, bladder pain, increased expression of nitrotyrosine, decreased expression of endothelial tight junction zonula occludens-1. Intravesical Vessilen® treatment was able to ameliorate CYP induced bladder inflammation and pain by inhibiting nuclear factor-κB pathway and inflammatory mediator levels as well as reduced mechanical allodynia and nerve growth factor levels. A significant improvement in quality of life and symptom intensity were evident in patients with IC/BPS or other bladder disorders treated with Vessilen ® . Vessilen ® could be a new therapeutic approach for human cystitis., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Aims: Intravesical instillation of hyaluronic acid (HA) plus chondroitin sulfate (CS) in women with bladder pain syndrome/interstitial cystitis (BPS/IC) has shown promising results. This study compared the efficacy, safety, and costs of intravesical HA/CS (Ialuril ® , IBSA) to dimethyl sulfoxide (DMSO)., Methods: Randomized, open-label, multicenter study involving 110 women with BPS/IC. The allocation ratio (HA/CS:DMSO) was 2:1. Thirteen weekly instillations of HA (1.6%)/CS (2.0%) or 50% DMSO were given. Patients were evaluated at 3 (end-of-treatment) and 6 months. Primary endpoint was reduction in pain intensity at 6 months by visual analogue scale (VAS) versus baseline. Secondary efficacy measurements were quality of life and economic analyses., Results: A significant reduction in pain intensity was observed at 6 months in both treatment groups versus baseline (P < 0.0001) in the intention-to-treat population. Treatment with HA/CS resulted in a greater reduction in pain intensity at 6 months compared with DMSO for the per-protocol population (mean VAS reduction 44.77 ± 25.07 vs. 28.89 ± 31.14, respectively; P = 0.0186). There were no significant differences between treatment groups in secondary outcomes. At least one adverse event was reported in 14.86% and 30.56% of patients in the HA/CS and DMSO groups, respectively. There were significantly fewer treatment-related adverse events for HA/CS versus DMSO (1.35% vs. 22.22%; P = 0.001). Considering direct healthcare costs, the incremental cost-effectiveness ratio of HA/CS versus DMSO fell between 3735€/quality-adjusted life years (QALY) and 8003€/QALY., Conclusions: Treatment with HA/CS appears to be as effective as DMSO with a potentially more favorable safety profile. Both treatments increased health-related quality of life, while HA/CS showed a more acceptable cost-effectiveness profile., (© 2016 Wiley Periodicals, Inc.)

Objectives: Bladder pain syndrome/interstitial cystitis, a chronic inflammatory condition of the bladder, is the source of pain in over 30% of female patients with chronic pelvic pain. The aim of the present study was to evaluate the most frequent associations between bladder pain syndrome/interstitial cystitis and gynecological disorders., Methods: A literature review of the previous 10 years was carried out to evaluate the incidence of gynecological diseases in patients with bladder pain syndrome/interstitial cystitis., Results: Hypertonic pelvic floor dysfunction with associated voiding dysfunction can be present in bladder pain syndrome/interstitial cystitis patients. It has been estimated that the prevalence ranges from 50% to 87%. Endometriosis affects 1-7% of the general population and up to 70% of women with endometriosis have some type of pain symptoms, a recent systematic review estimated the prevalence of bladder pain syndrome to be 61%, of endometriosis to be 70%, and coexisting bladder pain syndrome and endometriosis to be 48%. Vulvodynia is represented by pain, or an unpleasant altered sensation, in the vulva. Women with vestibulodynia are likely to have other additional pain conditions, such as fibromyalgia, irritable bowel syndrome or chronic fatigue syndrome. Recent data reported that vestibulodynia affects 25% of women with bladder pain syndrome/interstitial cystitis., Conclusions: Bladder pain syndrome/interstitial cystitis is a complex pathology often associated with vulvodynia, endometriosis and pelvic floor dysfunctions. Therefore, it is of utmost importance to obtain an accurate evaluation ruling out confusable disease, such as pudendal neuropathy. The optimal approach is a combined treatment oriented not only to treat the bladder, but also the other components responsible for the pain disorder., (© 2014 The Japanese Urological Association.)

Introduction and Hypothesis: Reconstruction of the glycosaminoglycan layer plays a role in the successful treatment of bladder pain syndrome/interstitial cystitis (BPS/IC). Intravesical instillations of hyaluronic acid (HA) and chondroitin sulphate (CS) have given results in the short term. We hypothesise that these benefits continue in the longer term., Methods: With the aim of evaluating this therapy over a longer period we treated 12 BPS/IC patients refractory to other treatments with a combination of HA 1.6 % and CS 2.0 % over a period of 3 years assessing symptoms and quality of life using a visual analogue scale, 3-day voiding diaries and validated questionnaires., Results: Improvements in bladder function were sustained for 3 years (mean number of daily voids decreased from 17.8 at baseline to 15.5 at 9 months and 11.9 at 3 years, and mean volume per void from 136.8 ml at baseline to 143.9 ml at 9 months and 180.9 ml at 3 years). Quality of life assessments confirmed these improvements., Conclusions: Intravesical instillations of HA and CS produced a sustained improvement of the symptomatology, up to 3 years, in patients with BPS/IC refractory to previous treatments. Further confirmation would be expected from larger controlled trials.

The aims of this study were to evaluate the efficacy and tolerability of intravesical instillations of high-molecular-weight hyaluronic acid (HA) 1.6% and chondroitin sulfate (CS) 2.0% in patients with refractory painful bladder syndrome/interstitial cystitis (PBS/IC) and to observe their impact on Quality of Life. Twenty-three women were enrolled. They received bladder instillations with HA and CS weekly for 20 weeks and then monthly for 3 months. Mean follow-up after completion of therapy was 5 months. We observed a significant improvement in urinary symptoms on voiding diaries and Visual Analogue Scale for frequency (p = 0.045), urgency (p = 0.005), and pain (p = 0.001). The O'Leary-Sant Interstitial Cystitis Symptom Index and Interstitial Cystitis Problem Index resulted in a significant improvement in both scores (p = 0.004 and 0.01, respectively). The Pelvic Pain and Urgency/Frequency Symptom Scale only showed significant improvement in the symptom score (p = 0.001). This promising experience seems to offer an additional therapeutic option in patients with refractory PBS/IC.

Objectives: The aim of our study was to test the effect of a more viscous compound than existent hyaluronic acid formulation in helping to restore a defective glycosaminoglycan layer, and therefore in improving Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) symptoms when administered intravesically in IC/PBS patients., Methods: A total of 23 female patients completed the study. Patients received endovesical administration of hyaluronic acid and chondroitin sulfate in normal saline, 40 ml, weekly for 12 weeks and then bi-weekly for 6 months, if there was initial response., Results: After 12 weeks treatment both Interstitial Cystitis Symptom and Problem Index (ICSI/ICPI), pelvic pain and Urgency/Frequency Symptom Scale (PUF) showed a mean significant improvement, which was maintained thereafter. The average number of voidings and mean voiding volumes revealed significant improvement after the 12 weeks' treatment period, with a significant reduction and increase, respectively. Mean voiding volume increased from 143 ml to 191, which apparently was not reflected in a corresponding reduction of number of daily voids (from 15,5 to 14). VAS values decreased from 5,4 to 3,6 (pain) and from 6,0 to 3,5 (urgency) after the treatment cycle, showing a significant improvement., Conclusions: In our preliminary experience, the administration of intravesical hyaluronic acid plus chondroitine sulphate appears to be a safe and efficacious method of treatment in IC/PBS.

Objectives: Because the term "interstitial cystitis" (IC) has different meanings in different centers and different parts of the world, the European Society for the Study of Interstitial Cystitis (ESSIC) has worked to create a consensus on definitions, diagnosis, and classification in an attempt to overcome the lack of international agreement on various aspects of IC., Methods: ESSIC has discussed definitions, diagnostic criteria, and disease classification in four meetings and extended e-mail correspondence., Results: It was agreed to name the disease bladder pain syndrome (BPS). BPS would be diagnosed on the basis of chronic pelvic pain, pressure, or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or urinary frequency. Confusable diseases as the cause of the symptoms must be excluded. Classification of BPS types might be performed according to findings at cystoscopy with hydrodistention and morphologic findings in bladder biopsies. The presence of other organ symptoms as well as cognitive, behavioral, emotional, and sexual symptoms, should be addressed., Conclusions: The name IC has become misleading and is replaced by BPS. This name is in line with recent nomenclature recommendations by the European Association of Urology and is based on the axial structure of the International Association for the Study of Pain classification. To facilitate the change of the name, ESSIC agreed to include IC in the overall term (BPS/IC) during this transition period.