Efficacy and Safety of Mirabegron Add-on Therapy to Solifenacin in Incontinent Overactive Bladder Patients with an Inadequate Response to Initial 4-Week Solifenacin Monotherapy: A Randomised Double-blind Multicentre Phase 3B Study (BESIDE)

AbstractBackgroundIncontinence has a greater detrimental effect on quality of life than other symptoms of overactive bladder (OAB) and is often difficult to treat with antimuscarinic monotherapy.ObjectiveTo evaluate the efficacy and the safety and tolerability of combination (solifenacin 5mg and mirabegron 50mg) versus solifenacin 5 or 10mg in OAB patients remaining incontinent after 4 wk of solifenacin 5mg.Design, setting, and participantsOAB patients remaining incontinent despite daily solifenacin 5mg during 4-wk single-blind run-in were randomised 1:1:1 to double-blind daily combination or solifenacin 5 or 10mg for 12 wk. Patients receiving the combination were initiated on mirabegron 25mg increasing to 50mg after week 4.Outcome measurements and statistical analysisThe primary end point was a change from baseline to end of treatment (EOT) in the mean number of incontinence episodes per 24h (stratified rank analysis of covariance [ANCOVA]). Key secondary end points were a change from baseline to EOT in the mean number of micturitions per 24h (ANCOVA) and number of incontinence episodes noted in a 3-d diary at EOT (mixed-effects Poisson regression). A trial (BESIDE) comparing combination treatment (solifenacin plus mirabegron) with one treatment alone (solifenacin) tested the superiority of combination versus solifenacin 5mg, noninferiority (and potential superiority) of combination versus solifenacin 10mg (key secondary end points), and the safety and tolerability of combination therapy versus solifenacin monotherapy.Results and limitationsA total of 2174 patients were randomised to combination (n=727), solifenacin 5mg (n=728), or solifenacin 10mg (n=719). At EOT, combination was superior to solifenacin 5mg, with significant improvements in daily incontinence (p=0.001), daily micturitions (p<0.001), and incontinence noted in a 3-d diary (p=0.014). Combination was noninferior to solifenacin 10mg for key secondary end points and superior to solifenacin 10mg for improving daily micturitions. All treatments were well tolerated.ConclusionsAdding mirabegron 50mg to solifenacin 5mg further improved OAB symptoms versus solifenacin 5 or 10mg, and it was well tolerated in OAB patients remaining incontinent after initial solifenacin 5mg.Patient summaryIn this 12-wk study, overactive bladder patients who remained incontinent despite initial solifenacin 5mg treatment received additional treatment with mirabegron 50mg. Combining mirabegron 50mg with solifenacin 5mg was superior to solifenacin 5mg alone in improving symptoms of incontinence and frequent urination, and it was well tolerated.Trial registrationClinicalTrials.gov NCT01908829

EVALUATION OF INCONTINENCE, QUALITY OF LIFE AND SEXUAL FUNCTION IN WOMEN WHO OPERATED SUBURETHRAL SLING

eden bir hastalık olmamasına rağmen, psikolojik, sosyal ve cinsel problemlerle yaşam kalitesi üzerinde olumsuz etkileri olduğu gösterilmiştir. Çalışmamızda orta üretral askı operasyonu sonrası kadınların cinsel fonksiyon, idrar kaçırma ve yaşam kalitesinin araştırılması amaçlandı. Gereç ve yöntem: Ekim 2005 ile Mart 2007 tarihleri arasında stres ve karışık tipte idrar kaçırma nedeniyle orta üretral askı operasyonu yapılan 29 cinsel aktif kadın hasta değerlendirildi. Hastalardan tıbbi ve cinsel öykü alınarak, Kadın Cinsel Fonksiyon İndeksi ve İnkontinans Yaşam Kalitesi Ölçeği dolduruldu. Verilerin değerlendirilmesinde sayı, yüzde dağılımı, McNeamer analizi, ki-kare ve t testleri kullanıldı. Bulgular: Çalışmaya alınan kadınların ortalama yaş ve kadın cinsel fonksiyon indeksi skoru sırasıyla 50,4 ± 8,8 yıl ve 19,3 ± 10,7 olarak saptandı. Kadın cinsel fonksiyon indeksi skoruna göre (<25) çalışmaya alınan %65,5 kadında cinsel fonksiyon bozukluğu saptandı. Operasyon sonrası kadınlar yaşam kalitelerinden memnundu. Operasyon öncesi %69'u cinsel ilişkilerinde idrar kaçırırken, operasyon sonrasında bu oranın %21 olduğu saptandı. Orta üretral askı ameliyatı sonrası hastaların %52'si cinsel yaşamlarından daha memnun olduklarını belirtti. Sonuç: Orta üretral askı operasyonu sonrasında kadınların inkontinans yakınmalarında düzelme olduğu ve yaşam kalitelerinden memnun olduğu görülürken, cinsel fonksiyon bozukluğu prevalansının önemli düzeyde yüksek olduğu görülmektedir. Objective: Although urinary incontinence is not a life threatening disorder, it has been shown to have detrimental effects on quality of life in terms of psychological, social and sexual problems. The aim of this study was to evaluate the effects of suburethral sling operation on sexual function, incontinence and quality of life. Material and method: Twenty nine women were evaluated who underwent suburethral sling operation for stress and mixed incontinence from October 2005 to March 2007. All women and their partners were sexually active. We evaluated all the women enrolled in the study by taking incontinence and sexual history, administering the Female Sexual Function Index (FSFI) and Incontinence Quality of Life Instrument. Number (I-QOL), percent distribution, McNeamer, chi square and t tests were used for the data analysis. Results: Mean age and FSFI scores of women were 50.4±8.8 years and 19.3 ± 10.7, respectively. According to total FSFI score (<25) there were 65.5% subjects had sexual dysfunction. Quality of life was improved after suburetral sling in female patients. Reported urinary leakage during intercourse was significantly reduced (69% to 21%). Among the patients 52% of them were reported an improvement of their sexual life after suburetral sling surgery. Conclusion: This study showed that suburetral sling procedures as anti-incontinence surgery is associated with reduced complaints of incontinence and improvement of the quality of life. However, prevalence of female sexual dysfunction is significantly high in these patients

Relationship between carotid intima-media thickness and coronary angiographic findings: a prospective study

<p>Abstract</p> <p>Background</p> <p>Since cardiovascular diseases are associated with high mortality and generally undiagnosed before the onset of clinical findings, there is a need for a reliable tool for early diagnosis. Carotid intima-media thickness (CIMT) is a non-invasive marker of coronary artery disease (CAD) and is widely used in practice as an inexpensive, reliable, and reproducible method. In the current study, we aimed to investigate prospectively the relationship of CIMT with the presence and extent of significant coronary artery narrowing in patients evaluated by coronary angiography for stable angina pectoris.</p> <p>Methods</p> <p>One hundred consecutive patients with stable angina pectoris and documented ischemia on a stress test were included in the study. The patients were divided into two groups according to the result of the coronary angiography: group 1 (39 patients) without a noncritical coronary lesion, and group 2 (61 patients) having at least one lesion more than 50% within the main branches of the coronary arteries. All of the patients underwent carotid Doppler ultrasound examination for measurement of the CIMT by a radiologist blinded to the angiographic data.</p> <p>Results</p> <p>The mean CIMT was 0.78 ± 0.21 mm in Group 1, while it was 1.48 ± 0.28 mm in Group 2 (p = 0.001). The mean CIMT in patients with single vessel disease, multi-vessel disease, and left main coronary artery disease were significantly higher compared to Group 1 (1.2 ± 0.34 mm, p = 0.02; 1.6 ± 0.32 mm, p = 0.001; and 1.8 ± 0.31 mm, p = 0.0001, respectively). Logistic regression analysis identified CIMT (OR 4.3, p < 0.001) and hypertension (OR 2.4, p = 0.04) as the most important factors for predicting CAD.</p> <p>Conclusions</p> <p>The findings of this study show that increase in CIMT is associated with the presence and extent of CAD. In conclusion, we demonstrated the usefulness of carotid intima-media thickness in predicting coronary artery disease but large-scale studies are required to define its role in clinical practice.</p

Cisplatin and etoposide chemotherapy in the treatment of adult Wilms' tumor

A 64-year-old man underwent left radical nephrectomy for stage III anaplastic Wilms' tumor. He received adjuvant chemotherapy consisting of cisplatin and etoposide. Complete clinical response was achieved and maintained for 12 months. A systemic relapse after 1 year also responded to three more cycles of cisplatin and etoposide. Although cisplatin- and etoposide-based chemotherapy was not used as a first-line therapy in adult patients with Wilms' tumor described in the literature, this case demonstrates the promising activity of this combination also in adults with this disease entity

Percutaneous embolization of persistent urinary fistula after partial nephrectomy using N-butyl-2-cyanoacrylate

Percutaneous closure of a calyceal fistula following partial nephrectomy for kidney cancer was achieved with fistula embolization with n-butyl-2-cyanoacrylate. Previous attempts at closure by conservative and endoscopic means were unsuccessful. Tissue adhesives are useful in the management of persistent urinary leakage after partial nephrectomy

Relation between acute urinary retention, chronic prostatic inflammation and accompanying elevated prostate-specific antigen

Objective. To determine if there is a relationship between acute urinary retention ( AUR), the prostate- specific antigen ( PSA) level and chronic inflammation of the prostate. We therefore studied patients with benign prostatic obstruction ( BPO) with ( n = 64) or without ( n = 168) acute urinary retention ( AUR) who underwent transurethral resection of the prostate ( TURP) in a retrospective case control study

A prospective analysis of sexual functions during pregnancy

The aim of the study was to evaluate the sexual functions during pregnancy using the Female Sexual Function Index (FSFI) questionnaire. Pregnancies were recorded in a prospective cohort study comprising 40 healthy pregnant women. Pregnant women who had a stable relationship with their partner were enrolled in the study when were first diagnosed to be pregnant. During their antenatal visits, subjects were asked to complete the FSFI questionnaire and other information about their sexual life in each trimester. Each FSFI domain score was calculated and mean scores in each domain were compared according to the trimesters of pregnancy. Data of 37 subjects for the first, 36 for the second and 34 for the third trimesters of pregnancy were eligible for the analysis. The mean age was 25.5 +/- 4.5 y; mean parity was 0.4 +/- 0.7 and mean gravity was 1.6 +/- 0.9. The frequency of intercourse attempts during the last 4 weeks was 8.6 +/- 3 before pregnancy, and 6.9 +/- 2.5, 5.4 +/- 2.6 and 2.5 +/- 1.4 in the first, second and third trimesters of pregnancy, respectively. In all domains of FSFI, significant decline in domain scores was determined during pregnancy. The comparison of satisfaction and pain domain scores between first and second trimesters showed significant differences. All of the domain scores significantly decreased in the third trimester of pregnancy. Our results showed that sexual functions are significantly decreased during pregnancy and worsen as the pregnancy progresses. Childbearing couples should be given information about the sexual problems and fluctuations in the patterns of sexuality during pregnancy