An adaptive randomized clinical trial in interstitial cystitis/bladder pain syndrome evaluating efficacy of ASP3652 and the relationship between disease characteristics and Hunner's lesions.

PURPOSE: The primary purpose of this study was to evaluate the effect of the fatty acid amide hydrolase (FAAH) inhibitor ASP3652 on efficacy and safety in patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). The secondary purpose was to evaluate phenotyping based on Hunner's lesions (HL). METHODS: In this randomized trial, adult female patients with moderate/severe IC/BPS received 12 weeks of treatment with an oral dose of ASP3652 (50, 150, or 300 mg twice daily) or placebo. A Bayesian model was employed using accumulating data to adjust the randomization probability and to analyze the primary efficacy variable (change from baseline to end of treatment in Mean Daily Pain [MDP; range 0-10]). Study outcomes and patient characteristics of patients with and without HL (HL+ and HL-) were compared. RESULTS: In total, 287 patients were randomized. The 300 mg dose group (n = 97) showed the largest effect, i.e., a mean change from baseline to end of treatment of -1.73 in MDP. However, the mean difference from placebo was 0.02. The probability that this dose was better than placebo was 13.5%. Adverse event incidence was low and similar between study groups. HL+ patients were older and had more severe symptoms than HL-. An association was suggested in HL+ patients between changes in micturition frequency and MDP (R = 0.41 [95% CI 0.18, 0.63]), which was not observed in HL- (R = 0.04 [95% CI -0.16, 0.29]). CONCLUSION: ASP3652 was safe and well tolerated, but did not show efficacy in IC/BPS. The observed differences between HL+ and HL- suggest that IC/BPS diagnosis and treatment may be approached differently in these two phenotypes. TRIAL REGISTRATION: EudraCT number 2011-004555-39, date of registration: 2012-05-07.

Hunner lesion disease differs in diagnosis, treatment and outcome from bladder pain syndrome: an ESSIC working group report.

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.

Implantation of the argus sling in a hard-to-treat patient group with urinary stress incontinence.

INTRODUCTION: Awareness of prostate cancer is growing in the Western population, and an increasing number of patients are being referred to prostate surgery. This is a significant contributor to male stress urinary incontinence (SUI). Implantation of an artificial sphincter (AUS) is considered the gold standard treatment of SUI. This study investigates the role of minimally invasive treatment with the Argus sling in a heterogenic hard-to-treat patient group. METHOD: The study was a retrospective follow-up study with patients as their own controls. Forty-one patients were enrolled and treated with the Argus sling. Patients enrolled had persisting SUI after prostate surgery for more than 12 months, despite conservative treatment. The pre-operative daily usage of pads and the 24 hours urinary leakage were compared to the post-operative findings. The primary goal was to achieve complete continence or a reduction of more than 50% in pad usage or urinary leakage. RESULTS: In total, 71% of the 41 patients enrolled met our primary objective. Complete continence was obtained in 56%, and a reduction of 50% or more was obtained in an additional 15%. CONCLUSION: This study has reproduced continence rates seen in previous studies, but in the hard-to-treat patients with urgency or formerly failed surgery, the continence rate was found to be inferior. The AUS has produced similar results and must still be considered the gold standard treatment of SUI, but the Argus sling is an alternative for patients who want a passive system or for patients not suitable for AUS.

Depression and Coping Behaviors Are Key Factors in Understanding Pain in Interstitial Cystitis/Bladder Pain Syndrome.

BACKGROUND: Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a urologic chronic pelvic pain syndrome with suboptimal treatment outcomes. Catastrophizing is an empirically supported risk factor for greater IC/BPS pain. AIMS: In this study, a moderated multiple mediation model is tested in which several additional psychosocial risk factors (depression, illness and wellness-focused behavioral coping strategies) are proposed as mediators or moderators in the existing relationship between catastrophizing and IC/BPS pain. DESIGN: The present questionnaire study employed a cross-sectional design. SETTINGS AND PARTICIPANTS: Female patients with an IC/BPS diagnosis (n = 341) were recruited at tertiary care sites. METHODS: Participants completed questionnaires assessing pain, catastrophizing, behavioral coping strategies, and depressive symptoms. Aggregate factor scores were calculated following exploratory factor analyses. RESULTS: It was found that patients with a greater tendency to catastrophize were more likely to engage in illness-focused coping strategies, which contributed to the reporting of greater sensory and affective pain. Furthermore, this mediating effect of illness-focused coping on affective pain was more likely to occur in those patients reporting greater depressive symptoms. CONCLUSIONS: Illness-focused behavioral coping is an important mechanism between maladaptive pain cognition and aspects of patient pain, with patients reporting greater depressive symptoms at increased risk for elevated pain. Patient management techniques, including screening for catastrophizing, coping, and depression, are recommended to enrich IC/BPS management.

A standard for terminology in chronic pelvic pain syndromes: A report from the chronic pelvic pain working group of the international continence society.

AIMS: Terms used in the field of chronic pelvic pain (CPP) are poorly defined and often confusing. An International Continence Society (ICS) Standard for Terminology in chronic pelvic pain syndromes (CPPS) has been developed with the aim of improving diagnosis and treatment of patients affected by chronic pelvic pain syndromes. The standard aims to facilitate research, enhance therapy development and support healthcare delivery, for healthcare providers, and patients. This document looks at the whole person and all the domains (organ systems) in a systematic way. METHODS: A dedicated working group (WG) was instituted by the ICS Standardisation Steering Committee according to published procedures. The WG extracted information from existing relevant guidelines, consensus documents, and scientific publications. Medline and other databases were searched in relation to each chronic pelvic pain domain from 1980 to 2014. Existing ICS Standards for terminology were utilized where appropriate to ensure transparency, accessibility, flexibility, and evolution. Consensus was based on majority agreement. RESULTS: The multidisciplinary CPPS Standard reports updated consensus terminology in nine domains; lower urinary tract, female genital, male genital, gastrointestinal, musculoskeletal, neurological aspects, psychological aspects, sexual aspects, and comorbidities. Each is described in terms of symptoms, signs and further evaluation. CONCLUSION: The document presents preferred terms and definitions for symptoms, signs, and evaluation (diagnostic work-up) of female and male patients with chronic pelvic pain syndromes, serving as a platform for ongoing development in this field. Neurourol. Urodynam. 36:984-1008, 2017. © 2016 Wiley Periodicals, Inc.

Depression and catastrophizing predict suicidal ideation in tertiary care patients with interstitial cystitis/bladder pain syndrome.

INTRODUCTION: We sought to evaluate psychosocial factors as predictors of suicidal ideation (SI) in a tertiary care outpatient sample of women suffering from interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: The patients are women managed at tertiary care centres (n=190). Controls were recruited from the community (n=117). Both groups completed questionnaires on demographics, pain (McGill Pain Questionnaire), IC/BPS symptoms, and psychological variables. Univariate and multivariate hierarchical regression modelling was conducted to examine the strength of associations and unique effects of psychosocial variables on patient SI. RESULTS: Compared to 6% in healthy controls, 23% of patients endorsed SI in the past two weeks. Correlations between SI, depression, and catastrophizing across controls and cases show that for controls, SI is associated with greater pain (0.31; p<0.01) and depression only (0.59; p<0.01). For tertiary care centre cases, SI is associated with pain (0.24; p<0.01), depression (0.64; p<0.01), and catastrophizing (0.35; p<0.01). Regression analyses indicated that psychosocial variables accounted for a significant amount of variance over and above IC/BPS symptoms. Catastrophizing (i.e., helplessness) about pain and depression were significant univariate predictors of SI, but only depression predicted SI in multivariable analyses. CONCLUSIONS: Limitations of this study include its cross-sectional design and primarily correlation-based statistics. The present study is the first to implicate multiple psychosocial risk factors over and above IC/BPS-specific symptoms and patient pain experience in SI in women with IC/BPS. Depression in particular is uniquely important in predicting suicidality. These results support a multidisciplinary, proactive approach to IC/BPS involving not only treatment of disease symptoms, but also early detection/treatment of associated psychosocial problems.

The Role of Glomerulations in Bladder Pain Syndrome: A Review.

PURPOSE: As a diagnostic marker for bladder pain syndrome/interstitial cystitis, glomerulations were first popularized by Messing and Stamey in 1978. Later this was included in the National Institute of Diabetes and Digestive and Kidney Diseases criteria for research and consequently used by many urologists as a default diagnostic criterion. Today the connection between glomerulations and bladder pain syndrome/interstitial cystitis is much debated as research has found glomerulations in asymptomatic populations. In this review we systematically examine the available research to see if there are valid data to support the use of glomerulations as a marker for bladder pain syndrome/interstitial cystitis. MATERIALS AND METHODS: A systematic literature search of the PubMed® database in March 2014 using the search term "Cystitis, Interstitial/diagnosis" [MAJR] OR (glomerulations OR glomerulation OR bladder petechiae) was performed, yielding 463 hits. An Embase® search using the search term "glomerulations" yielded 110 references, of which 68 were duplicates. Relevant articles were reviewed and included in the study. Bibliographies of reviews, articles and status reports were examined to find studies not included in the search. A total of 29 publications were included in this review. RESULTS: There is no consistent relationship between glomerulations and the diagnosis of bladder pain syndrome/interstitial cystitis. In the reviewed studies we found evidence of the grade of glomerulations changing with time. Furthermore, many studies showed no link between the severity of symptoms and the number of glomerulations. There were studies that found glomerulations in healthy asymptomatic populations as well as in symptomatic populations with another primary diagnosis. One study showed no glomerulations in an asymptomatic population. CONCLUSIONS: We found no convincing evidence in the reviewed literature that glomerulations should be included in the diagnosis or phenotyping of bladder pain syndrome/interstitial cystitis. Glomerulations do not correlate with symptoms and are found in patients without bladder pain syndrome/interstitial cystitis.

Functional and molecular evidence for Kv7 channel subtypes in human detrusor from patients with and without bladder outflow obstruction.

The aim of the study was to investigate whether Kv7 channels and their ancillary ß-subunits, KCNE, are functionally expressed in the human urinary bladder. Kv7 channels were examined at the molecular level and by functional studies using RT-qPCR and myography, respectively. We found mRNA expression of KCNQ1, KCNQ3-KCNQ5 and KCNE1-5 in the human urinary bladder from patients with normal bladder function (n = 7) and in patients with bladder outflow obstruction (n = 3). Interestingly, a 3.4-fold up-regulation of KCNQ1 was observed in the latter. The Kv7 channel subtype selective modulators, ML277 (activator of Kv7.1 channels, 10 µM) and ML213 (activator of Kv7.2, Kv7.4, Kv7.4/7.5 and Kv7.5 channels, 10 µM), reduced the tone of 1 µM carbachol pre-constricted bladder strips. XE991 (blocker of Kv7.1-7.5 channels, 10 µM) had opposing effects as it increased contractions achieved with 20 mM KPSS. Furthermore, we investigated if there is interplay between Kv7 channels and ß-adrenoceptors. Using cumulative additions of isoprenaline (ß-adrenoceptor agonist) and forskolin (adenylyl cyclase activator) in combination with the Kv7 channel activator and blocker, retigabine and XE991, we did not find interplay between Kv7 channels and ß-adrenoceptors in the human urinary bladder. The performed gene expression analysis combined with the organ bath studies imply that compounds that activate Kv7 channels could be useful for treatment of overactive bladder syndrome.

Diagnosis of bladder tumours in patients with macroscopic haematuria: a prospective comparison of split-bolus computed tomography urography, magnetic resonance urography and flexible cystoscopy.

OBJECTIVE: The aim of this study was to compare split-bolus computed tomography urography (CTU), magnetic resonance urography (MRU) and flexible cystoscopy in patients with macroscopic haematuria regarding the diagnosis of bladder tumours. MATERIALS AND METHODS: In this prospective study, 150 patients underwent CTU, MRU and flexible cystoscopy. Two uroradiologists individually reviewed the images without any clinical information, using a questionnaire. Patient records and pathology reports were also reviewed. RESULTS: At flexible cystoscopy, MRU and CTU, 32, 19 and 15 bladder lesions were identified, respectively. Histopathology showed that 13 of the 29 biopsied lesions were transitional cell carcinomas. Compared with the histopathology, the sensitivity and specificity for detection of tumours by CTU and MRU were 61.5% and 94.9%, and 79.9% and 93.4%, respectively. False-positive detection of bladder tumours, compared with histopathology, was reported in seven CTUs and nine MRUs, whereas the number of false-negative findings was five for CTUs and three for MRUs. CONCLUSIONS: Split-bolus CTU or MRU cannot replace cystoscopy in cases of macroscopic haematuria. MRU has a higher sensitivity than split-bolus CTU, and is a potential alternative to flexible cystoscopy. Patients with a low risk of bladder cancer may forgo flexible cystoscopy if a bladder tumour is identified by either CTU or MRU, and proceed straight to transuretheral resection of the bladder.

Ileal conduit without cystectomy may be an appropriate option in the treatment of intractable bladder pain syndrome/interstitial cystitis.

OBJECTIVE: The aim of this study was to report the outcomes of urinary diversion for bladder pain syndrome/interstitial cystitis (BPS/IC) at a large university hospital over a period of more than 10 years. MATERIAL AND METHODS: Chart reviews were performed for BPS/IC patients who had undergone ileal conduit with or without cystectomy. Questionnaires on quality of life, BPS/IC symptoms and pain were mailed to patients. Outcomes in the cystectomy and the non-cystectomy groups were compared with Fisher's exact test. RESULTS: Ileal conduit without cystectomy was performed in 20 patients. Two underwent a subsequent cystectomy owing to persistent symptoms. Three patients underwent ileal conduit with concomitant primary cystectomy. Nineteen patients were alive at the time of the study and 15 returned the questionnaires. Twelve responders had been treated with ileal conduit and three had undergone primary cystectomy. The quality of life in both the cystectomy and the non-cystectomy groups was comparable with that in the general population. Seven patients in the non-cystectomy group were free of specific BPS/IC symptoms. The remaining five patients had minimal symptoms. Two cystectomy patients were free of symptoms, while one still suffered from severe symptoms. Eleven patients reported having no pain while four patients had visual analogue scale (VAS) scores between 2 and 9.5. Three patients experiencing pain belonged to the non-cystectomy group. There was no difference between the cystectomy group and the non-cystectomy group with regard to the proportion of patients who were symptom free. CONCLUSION: Ileal conduit without cystectomy may be an appropriate option when performing urinary diversion in BPS/IC patients.

Upper urinary tract tumors: how does the contrast enhancement measured in a split-bolus CTU correlate to histological staging?

BACKGROUND: Computed tomography urography (CTU) is used widely in the work-up of patients with symptoms of urinary tract lesions. Preoperative knowledge of whether a tumor is invasive or non-invasive is important for the choice of surgery. So far there are no studies about the distinction of invasive and non-invasive tumors in ureter and renal pelvis based on the enhancement measured with Hounsfield Units. PURPOSE: To examine the value of CTU using split-bolus technique to distinguish non-invasive from invasive urothelial carcinomas in the upper urinary tract. MATERIAL AND METHODS: Patients who underwent nephroureterectomy between 2006 and 2011 and who had split-bolus CTU prior to surgery were included. The images were available electronically. The attenuation values before and after administration of iodine-based contrast media were measured. The radiology, patient, and pathology records were reviewed. RESULTS: Of the 158 patients who underwent unilateral nephroureterectomy 69 fulfilled the inclusion criteria. Histopathological examination revealed 31 patients with non-invasive and 38 with invasive urothelial carcinoma. Neither absolute attenuation nor change in attenuation values obtained at CTU could distinguish between invasive and non-invasive lesions. No patients had a CTU within the last year before the examination that resulted in surgery. CONCLUSION: A split-bolus CTU cannot distinguish between invasive and non-invasive urothelial tumors in the upper urinary tract, but the examination is useful to diagnose a tumor in the renal pelvis and the ureter.

Bladder contractility is modulated by Kv7 channels in pig detrusor.

Kv7 channels are involved in smooth muscle relaxation, and accordingly we believe that they constitute potential targets for the treatment of overactive bladder syndrome. We have therefore used myography to examine the function of Kv7 channels in detrusor, i.e. pig bladder, with a view to determining the effects of the following potassium channel activators: ML213 (Kv7.2/Kv7.4 channels) and retigabine (Kv7.2-7.5 channels). Retigabine produced a concentration-dependent relaxation of carbachol- and electric field-induced contractions. The potency was similar in magnitude to that of ML213-induced relaxation, suggesting that Kv7.2 and/or Kv7.4 channels constitute the subtypes that are relevant to bladder contractility. The effects of retigabine and ML213 were attenuated by pre-incubation with 10µM XE991 (Kv7.1-7.5 channel blocker) (P<0.05), which in turn confirmed Kv7 channel selectivity. Subtype-selective effects were further investigated by incubating the detrusor with 10µM chromanol 293B (Kv7.1 channel blocker). Regardless of the experimental protocol, this did not cause a further increase in the evoked contraction. In contrast, the addition of XE991 potentiated the KCl-induced contractions, but not those induced by carbachol or electric field, indicating the presence of a phosphatidyl-inositol-4,5-biphosphate-dependent mechanism amongst the Kv7 channels in detrusor. qRT-PCR studies of the mRNA transcript level of Kv7.3-7.5 channels displayed a higher level of Kv7.4 transcript in detrusor compared to that present in brain cortex and heart tissues. Thus, we have shown that Kv7.4 channels are expressed and functionally active in pig detrusor, and that the use of selective Kv7.4 channel modulators in the treatment of detrusor overactivity seems promising.

EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction.

OBJECTIVE: To present a summary of the 2013 version of the European Association of Urology guidelines on the treatment and follow-up of male lower urinary tract symptoms (LUTS). EVIDENCE ACQUISITION: We conducted a literature search in computer databases for relevant articles published between 1966 and 31 October 2012. The Oxford classification system (2001) was used to determine the level of evidence for each article and to assign the grade of recommendation for each treatment modality. EVIDENCE SYNTHESIS: Men with mild symptoms are suitable for watchful waiting. All men with bothersome LUTS should be offered lifestyle advice prior to or concurrent with any treatment. Men with bothersome moderate-to-severe LUTS quickly benefit from α1-blockers. Men with enlarged prostates, especially those >40ml, profit from 5α-reductase inhibitors (5-ARIs) that slowly reduce LUTS and the probability of urinary retention or the need for surgery. Antimuscarinics might be considered for patients who have predominant bladder storage symptoms. The phosphodiesterase type 5 inhibitor tadalafil can quickly reduce LUTS to a similar extent as α1-blockers, and it also improves erectile dysfunction. Desmopressin can be used in men with nocturia due to nocturnal polyuria. Treatment with an α1-blocker and 5-ARI (in men with enlarged prostates) or antimuscarinics (with persistent storage symptoms) combines the positive effects of either drug class to achieve greater efficacy. Prostate surgery is indicated in men with absolute indications or drug treatment-resistant LUTS due to benign prostatic obstruction. Transurethral resection of the prostate (TURP) is the current standard operation for men with prostates 30-80ml, whereas open surgery or transurethral holmium laser enucleation is appropriate for men with prostates >80ml. Alternatives for monopolar TURP include bipolar TURP and transurethral incision of the prostate (for glands <30ml) and laser treatments. Transurethral microwave therapy and transurethral needle ablation are effective minimally invasive treatments with higher retreatment rates compared with TURP. Prostate stents are an alternative to catheterisation for men unfit for surgery. Ethanol or botulinum toxin injections into the prostate are still experimental. CONCLUSIONS: These symptom-oriented guidelines provide practical guidance for the management of men experiencing LUTS. The full version is available online (www.uroweb.org/gls/pdf/12_Male_LUTS.pdf).

The novel ß3-adrenoceptor agonist mirabegron reduces carbachol-induced contractile activity in detrusor tissue from patients with bladder outflow obstruction with or without detrusor overactivity.

ß(3)-Adrenoceptors are major players in detrusor relaxation and have been suggested as a new putative target for the treatment of overactive bladder syndrome. We determined the effects of mirabegron (YM178), a novel ß(3)-adrenoceptor agonist, on carbachol-induced tone in isolated human detrusor preparations from patients with bladder outflow obstruction (BOO) with and without detrusor overactivity (DO), and from patients with normal bladder function. We compared the effects to those of isoprenaline, a non-selective ß-adrenoceptor agonist. Detrusor specimens were obtained from patients with benign prostatic hyperplasia undergoing cystoscopy and from patients undergoing radical prostatectomy/cystectomy (in total 33 donors). Detrusor contractility was evaluated by organ bath studies and strips were incubated with carbachol (1µM) to induce and enhance tension. Both mirabegron and isoprenaline reduced carbachol-induced tone in tissues from all groups. Isoprenaline decreased tension with higher potency than mirabegron in normal, BOO and BOO+DO detrusor strips with pIC(50) values of 7.49 ± 0.16 vs. 6.23 ± 0.26 (P=0.0002), 6.89 ± 0.34 vs. 6.04 ± 0.31 (P=0.01), and 6.57 ± 0.20 vs. 5.41 ± 0.08 (P<0.0001, n=4), respectively. The maximal relaxant effect of isoprenaline and mirabegron in the normal, BOO and BOO+DO detrusor was 37.7 ± 14.4% and 36.1 ± 23.3%, 14.4 ± 12.2% vs. 33.4 ± 21.0% and 18.3 ± 10.0% vs. 28.3 ± 12.2% (n=4, P>0.05), respectively. Mirabegron and isoprenaline reduced carbachol-induced tone in both normal bladders and obstructed bladder with and without DO. Isoprenaline had higher potency than mirabegron, but the efficacy of mirabegron effect was the same as that of isoprenaline.

Mapping of pain phenotypes in female patients with bladder pain syndrome/interstitial cystitis and controls.

BACKGROUND: Many bladder pain syndrome/interstitial cystitis (BPS/IC) patients report multiple pain locations outside the pelvis. No research has examined pain using a whole-body diagram, pain-associated adjustment factors, or the impact of pain in multiple body areas on patients' quality of life (QoL). OBJECTIVE: Compare and contrast pain in BPS/IC patients and controls using a whole-body diagram (visible body areas). Examine the association between patient adjustment factors and greater number of body pain areas (pain phenotypes). DESIGN, SETTING, AND PARTICIPANTS: Validated questionnaires were collected from diagnosed, tertiary-care, outpatient, female BPS/IC patients (n=193) and age-matched controls (n=115). Scales included a body pain area diagram, demographics/history, pain severity, BPS/IC symptoms, pain, depression, catastrophizing, and QoL. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Cross-tabulation and analysis of variance models addressed the patient and control differences. RESULTS AND LIMITATIONS: Patients reported more pain than controls in all reported body areas. Four pain phenotypes were created based on increasing counts of body locations (BPS/IC only, BPS/IC+plus 1-3 additional locations, BPS/IC plus 4-9, BPS/IC ≥ 10). Patients reported more body pain locations, pain, urinary symptoms, depression, catastrophizing, and diminished QoL than controls. The increased-pain phenotype was associated with poorer psychosocial adjustment and diminished physical QoL, but catastrophizing and low scores for mental QoL remained stable across all patient groups. This study was cross-sectional, relying on correlation-based analyses, thus causality cannot be established. CONCLUSIONS: Patients reported numerous systemic pain symptoms outside the areas associated with the bladder/pelvic region, and increased numbers of body pain sites were associated with poorer patient outcomes (ie, pain severity, depression). This study illustrates the significant negative impact of pain on patient adjustment in BPS/IC. These findings suggest that clinicians carefully consider pain location distributions and the potential impact of body pain phenotypes during patient evaluation and treatment planning.

Adjustable continence balloons: clinical results of a new minimally invasive treatment for male urinary incontinence.

OBJECTIVE: This study aimed to evaluate the results of the Danish experience with the ProACT urinary continence device inserted in men with stress urinary incontinence. MATERIAL AND METHODS: The ProACT was inserted in 114 patients. Data were registered prospectively. The main endpoints were complications, pad use per day and 24 h urinary leakage. A questionnaire evaluating symptoms and satisfaction was sent to the patients. RESULTS: Data including preoperative and postoperative pad use and urinary leakage were available for 92 and 90 patients, respectively. A decrease in the median 24 h urinary leakage (352.5 vs 11 ml, p < 0.001) and in the median number of pads used per day (4.75 vs 2.25, p = 0.001) was demonstrated. Forty-six patients had a pad use of 0-1 pads per day and/or a daily urinary leakage less than 8 g, corresponding to an overall dry rate of 50%. A decrease in urinary leakage > 50% was seen in 72 patients (80%). Complications were seen in 23 patients. All of these were treated successfully by removal of the device in the outpatient setting followed by replacement of the device. Another eight patients had a third balloon inserted to improve continence further. Fourteen patients (12%) ended up with an artificial sphincter or a urethral sling. Sixty patients (63%) experienced no discomfort and 58 (61%) reported being dry or markedly improved. Overall, 50 patients (53%) reported being very or predominantly satisfied. CONCLUSIONS: Adjustable continence balloons seem to be a good alternative in the treatment of male urinary incontinence. Complications are mild and easily treated.