No abstract

This study details the further validation of the Premature Ejaculation Diagnostic Tool (PEDT), a fiveitem tool, developed to systematically apply the Diagnostic and Statistical Manual of Mental Disorders, revised version 4 (DSM-IV-TR), criteria in diagnosing presence or absence of premature ejaculation (PE). A total of 102 men completed the PEDT and were then interviewed by one of the seven clinical experts, who made a diagnosis of presence or absence of PE. The diagnoses from these two methods were compared to assess the convergent validity of PEDT. Retest reliability was also assessed, by men completing the PEDT a second time, approximately 2 weeks after the first administration. The level of agreement between clinical expert and PEDT diagnoses was very high (j-statistic ¼ 0.80 (95% CI ¼ 0.68-0.92)), and retest reliability was very good -Intraclass correlation coefficient ¼ 0.88. In summary, the PEDT is extensively validated, self-report measure that can systematically assess DSM-IV-TR criteria to provide accurate diagnoses of PE/no-PE.

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Study Type – Therapy (RCT)
Level of Evidence 1b OBJECTIVES To evaluate the efficacy and safety of the phosphodiesterase type 5 inhibitor UK‐369,003 for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in men with and without erectile dysfunction (ED). PATIENTS AND METHODS This was a multicentre, double‐blind, placebo‐ and active‐controlled, parallel‐group study conducted across 45 centres in North and South America, Europe, and Australia. In all, 418 men aged ≥40 years with a clinical diagnosis of BPH, an International Prostate Symptom Score (IPSS) of ≥13, and maximum urinary flow rate (Qmax) of 5–15 mL/s for a voided volume of >150 mL were stratified into two groups (with and without ED) and randomized to one of seven treatment groups, i.e. UK‐369,003 at 10, 25, 50 or 100 mg modified release (MR), UK‐369,003 40 mg immediate release (IR), tamsulosin 0.4 mg prolonged release, or placebo, for 12 weeks. The primary study endpoint was the change in total IPSS after 12 weeks of treatment. Secondary efficacy measures were IPSS storage and voiding subscores, Qmax, International Index of Erectile Function–Erectile Function domain, questions 5 and 6 of the Quality of Erection Questionnaire, the International Consultation on Incontinence Questionnaire–Male LUTS, the patient‐reported treatment‐impact questionnaire, and a bladder diary in which patients recorded the number of voluntary urinary voids, volume of urine voided per micturition, leaks, and urgency episodes. RESULTS The mean change in the IPSS from baseline at week 12 for UK‐369,003 100 mg MR and 40 mg IR was −2.91 and −2.50 better than placebo, respectively. There was increasing efficacy with increasing dose of the MR formulation. For UK‐369,003 100 mg MR, Qmax improved by 2.10 mL/s compared with 0.84 mL/s in the placebo group. CONCLUSIONS UK‐369,003 had clinically meaningful efficacy and was well tolerated in men with LUTS associated with BPH. The Bayesian statistical analysis gave high posterior probabilities for true differences between UK‐369,003 100 mg MR and placebo. There was greater preference, satisfaction and willingness to use UK‐369,003 again for all treatment groups compared with placebo.

Pregnancy is a time of great physical and psychological change. As well as prominent changes in the external appearance of the body, such as the baby bump, there are also substantial changes taking place within the body. Our awareness of, and attention towards, internal bodily signals (interoception) is thought to have a direct impact on how we feel about our bodies. Therefore, understanding how our experience of these interoceptive signals might change during pregnancy may have important implications for maternal wellbeing. This study examined body satisfaction and interoceptive sensibility (subjective experience of interoception) in pregnant and non-pregnant women with and without children. Feelings towards pregnancy-specific changes in body satisfaction and interoceptive sensibility were also examined in women in their first pregnancy (primigravida) and subsequent pregnancies (multigravida). It was found that pregnancy did not directly impact levels of body satisfaction, instead pregnant and non-pregnant women with children reported less satisfaction with their bodies compared to those without children. Primigravida women were more satisfied with the appearance of pregnancy specific bodily changes compared to multigravida women. Interestingly, these differences in body satisfaction in those with children (pregnant and non-pregnant) were mediated by the extent to which women trusted their bodies (measure of interoceptive sensibility). All other pregnancy related changes in interoceptive sensibility and body satisfaction were either non-significant or had small effect sizes. These results may suggest body trust as an important factor to support during the transition to parenthood in order to improve body satisfaction in mothers.