Introduction and hypothesis The objective of this study was to create a valid, reliable, and responsive sexual function measure in women with pelvic floor disorders (PFDs) for both sexually active (SA) and inactive (NSA) women. Methods Expert review identified concept gaps and generated items evaluated with cognitive interviews. Women underwent Pelvic Organ Prolapse Quantification (POPQ) exams and completed the Incontinence Severity Index (ISI), a prolapse question from the Epidemiology of Prolapse and Incontinence Questionnaire (ISI scores), the Pelvic Floor Distress Inventory-20 (PFDI-20), and the Female Sexual Function Index (FSFI). Principle components and orthogonal varimax rotation and principle factor analysis with oblique rotation identified item grouping. Cronbach's alpha measured internal consistency. Factor correlations evaluated criterion validation. Change scores compared to change scores in other measures evaluated responsiveness among women who underwent surgery. Results A total of 589 women gave baseline data, 200 returned surveys after treatment, and 147 provided test-retest A related editorial can be found at
Despite a re-evaluation of risks in recent years, hormone replacement therapy is still surrounded by controversy. Almost 30% of women in a recent survey sought a natural approach to combat climacteric symptoms. Nevertheless, a large proportion of patients felt that they wanted a good safety profile and strong evidence base for treatment. This article seeks to review the evidence supporting non-hormonal approaches to treatment. There is only conflicting evidence at best to support alpha-2 agonists, e.g. clonidine and limited evidence for dihydroepiandrosterone and natural progesterones. There is limited randomized controlled trial data for gabapentin, selective norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs), many of these studies being related to breast cancer patients. Of the herbal medicinal products, the largest evidence base rests with phytoestrogens. A Cochrane Database review looking at all types of phytoestrogens, e.g. red clover extracts, dietary soya and soya extracts concluded that there was no evidence to support improvement in climacteric symptoms and the meta-analysis of a 178 studies on soy products was inconsistent. Nevertheless, other studies disagree. Mammographic density is not affected by soy or phytoestrogen products and recent in vitro work shows only a weakly proliferative effect of soy isoflavone on breast cancer cells and evidence that soy isoflavone blocks the proliferative effect of estradiol on these cells. There are no studies looking at clinical outcome measures for cardiovascular disease but a number of studies looking at biochemical markers including arterial wall stiffness and apolipo protein B. Recent studies have also looked at the effects of red clover isoflavone on mood and depression, using specific depression rating scales. Finally, it is important to note that herbal medicinal products should not be used without caution. Some may produce quite marked side-effects in high doses and others can interact with pre-existing medication. A strategy for which patients are suitable for herbal medicinal products is reviewed.
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