Recovery after breast cancer surgery following recommended pre and postoperative physical activity: (PhysSURG-B) randomized clinical trial.

BACKGROUND: The effect of preoperative physical activity on recovery and complications after primary breast cancer surgery is unknown. The objective of this trial was to evaluate whether a recommendation of non-supervised physical activity improved recovery after breast cancer surgery. METHODS: This parallel, unblinded, multicentre interventional trial randomized women in whom breast cancer surgery was planned. The intervention consisted of an individual recommendation of added aerobic physical activity (30 min/day), before and 4 weeks after surgery. The control group did not receive any advice regarding physical activity. The primary outcome was patient-reported physical recovery at 4 weeks after surgery. Secondary outcomes included mental recovery, complications, reoperations, and readmissions. RESULTS: Between November 2016 and December 2018, 400 patients were randomized, 200 to each group. Some 370 participants (180 intervention, 190 control) remained at 4 weeks, and 368 at 90 days. There was no significant difference in favour of the intervention for the primary outcome physical recovery (risk ratio (RR) 1.03, 95 per cent c.i. 0.95 to 1.13). There was also no difference for mental recovery (RR 1.05, 0.93 to 1.17) nor in mean Comprehensive Complication Index score (4.2 (range 0-57.5) versus 4.7 (0-58.3)) between the intervention and control groups. CONCLUSION: An intervention with recommended non-supervised physical activity before and after breast cancer surgery did not improve recovery at 4 weeks after surgery. Registration number: NCT02560662 (http://www.clinicaltrials.gov).

Assessing female sexual arousal with the labial thermistor: response specificity and construct validity.

The labial thermistor offers several potential psychometric advantages over existing measures of female sexual response; however, the thermistor lacked data to support these presumed advantages, especially with respect to its discriminant validity. In this study, both the labial thermistor was worn simultaneously with the vaginal photoplethysmograph as women viewed films. They also indicated their level of subjective sexual arousal using a lever. The labial thermistor discriminated sexual from nonsexual arousing stimuli and was sensitive to different levels of sexual arousal. The correspondence of the instrument with subjective sexual arousal, measured using a continuous lever, was lower during the mildly arousing sexual film and higher during the maximally sexual arousing film. One woman reported that the labial thermistor was very uncomfortable, while others indicated no or mild discomfort from each instrument. The vaginal photoplethysmograph largely replicated the effects documented by the labial thermistor, although it did not discriminate sexual stimuli of different intensity nor correspond with women's continuous lever responses as closely during the more arousing stimulus. Difficulties recording simultaneously with these instruments are noted. The labial thermistor adequately discriminates between generally arousing and sexually arousing stimuli, increasing its utility as a measure for between-subject study designs.

Influence of PDE5 inhibitor on MRI measurement of clitoral volume response in women with FSAD: a feasibility study of a potential technique for evaluating drug response.

The purpose of this study was to determine if magnetic resonance imaging (MRI) could quantify a difference in clitoral response following administration of a vasoactive medication, in 12 women with female sexual arousal disorder (FSAD). Subjects were entered into a double-blind, randomized two-way crossover study of sildenafil 50 mg vs placebo administered 1 h prior to genital MRI. Each subject underwent two MR studies, performed while subjects viewed alternating segments of nonerotic and erotic video. MR images were analyzed for change in clitoral volume during each session. The mean change in clitoral volume for the entire group was higher in the sildenafil MRI session (1282 mm(3)) compared with placebo (849 mm(3)) but did not reach statistical significance (P=0.064). Comparison using analysis of variance between the two sessions for each individual subject revealed a significant increase in clitoral volume following sildenafil compared with placebo in 6 of 12 subjects, no significant change in either imaging session in three subjects and in three subjects, there was a robust clitoral response in both MR sessions. In conclusion, MR measurements of clitoral volume can provide an objective measure of engorgement change following a vasoactive medication in women with FSAD.

Sexual function and satisfaction in heterosexual couples when men are administered sildenafil citrate (Viagra) for erectile dysfunction: a multicentre, randomised, double-blind, placebo-controlled trial.

OBJECTIVE: To investigate the effect of improvement in erectile dysfunction (ED) on sexual function and satisfaction measures in heterosexual couples in which the woman reports that sexual intercourse is unsatisfactory at least half of the time. DESIGN: Multicentre, double-blind, placebo-controlled study. SETTING: Outpatient medical clinics. POPULATION: Hundred and eighty men with ED and their female partners in whom sexual intercourse was satisfactory about half the time or less (score of < or =3 on the Female Partner of ED Subject Questionnaire question 3 [FePEDS Q3]). METHODS: Men were randomised to flexible-dose sildenafil (25, 50, and 100 mg) or placebo as needed for 12 weeks. MAIN OUTCOME MEASURES: Primary: FePEDS Q3 ('Over the past four weeks, when you had sexual intercourse, how often was it satisfactory for you?') scored as 0 (no sexual activity) and 1 (almost never or never) to 5 (almost always or always). Secondary, partners: Sexual Function Questionnaire, Female Sexual Function Index (FSFI), and ED Inventory of Treatment Satisfaction (EDITS) partner version (EDITS-Partner). Secondary, men: International Index of Erectile Function (IIEF), General Efficacy Questions, event log data, Self-Esteem And Relationship questionnaire, and EDITS. Secondary, partners and men: Dyadic Adjustment Scale. RESULTS: The intention-to-treat population included 85 sildenafil recipients (mean age 59 +/- 12 years) and 91 placebo recipients (mean age 57 +/- 11 years). Most partners (aged 20-79 years; mean, 54 years) were postmenopausal. Sildenafil compared with placebo couples had greater improvement in the primary outcome (FePEDS Q3 [P < 0.0001]) and in sexual function, intercourse success rates, and secondary sexual satisfaction measures (FSFI satisfaction domain [P < 0.0001] and IIEF satisfaction domains [P < 0.001]) and had higher treatment satisfaction (EDITS and EDITS-Partner; P < 0.0001). Several predictors of improvement were identified, and improvement in one member of the couple correlated positively with improvement in the other member. CONCLUSIONS: The interdependence of sexual function and sexual satisfaction measures between members of couples consisting of men with ED and sexually healthy women reporting infrequent satisfactory sexual intercourse underscores the importance of including partners in ED treatment discussions.

Pharmacological preconditioning of rat liver by up-regulation of heme oxygenase 1.

PURPOSE: We investigated whether pharmacologically induced up-regulation of heme oxygenase 1 by pyrrolidine dithiocarbamate (PDTC) conferred protection against subsequent ischemia-reperfusion injury (IRI) to the rat liver after temporary vascular occlusion of 70% of the organ. METHODS: Female Wistar rats (200 to 250 g body weight) anesthetized with pentobarbitone were cannulated in the carotid artery and jugular vein. After laparotomy, a rubber band was applied around the entire vascular supply to the median and left lateral lobes, enabling vascular occlusion of 70% of the liver. A laser Doppler miniprobe was placed on the left lateral lobe to monitor peripheral liver blood flow (PLBF). Immediately upon completion of the surgery, the rats were administered either PDTC (50 mg/kg intravenously; n = 8) or its solvent (isotonic NaCl; n = 8). After 60 minutes, regional ischemia was induced for 30 minutes. The animals were then monitored for 2 hours of reperfusion. Blood samples for alanine transferase (ALT) estimation (as a measure of parenchymal injury) were drawn immediately prior to ischemia and reperfusion, as well as 60 and 120 minutes after reperfusion; PLBF was calculated at these times. RESULTS: ALT increased in the course of the experiments but there was no difference between the groups. The reduction in PBLF due to ischemia-reperfusion was significantly lower in the PDTC group: about 16% versus 40%, after 2 hours of reperfusion. CONCLUSION: Pretreatment with PDTC attenuated the disturbance of hepatic microcirculation, but not parenchymal injury, in the early phase of IRI.

Effect of remote preconditioning on mild or severe ischemia-reperfusion injury to rat liver.

UNLABELLED: In this study we examined the effect of remote ischemic preconditioning (RIPC) on liver ischemia-reperfusion (IR) injury. Anesthetized Wistar rats (200 to 250 g body weight, n = 32) had the right femoral artery (FA) dissected. Protocol I. The hepatic artery (HA) was clamped for 60 minutes; peripheral liver blood flow (PLBF) and alanine aminotransferase (ALT) were measured prior to clamping as well as 60 minutes after reperfusion. The cohorts were group 1 (no RIPC; n = 10) and group 2 (RIPC; n = 10) 35 minutes after surgery, the FA was clamped for 10 minutes. After 15 minutes, the HA was clamped as in group 1. In protocol II, a rubber band was applied around the entire vascular supply to about 70% of the liver, yielding group 3 (no RIPC; n = 6) that 60 minutes after surgery, had vascular occlusion performed for 30 minutes and group 4 (RIPC; n = 6) with the FA clamped as above, in a procedure otherwise identical to that of group 3. RESULTS: In protocol I, there was no significant difference in PLBF between the two groups after reperfusion, but the increased ALT levels in the RIPC group were reduced (.70 +/- .05 vs. 1.0 +/- .15 microkat/L, P = .049). In protocol II, we observed no significant differences in ALT levels or PLBF between the two groups. Thus, a beneficial effect of RIPC was demonstrated in protocol I with relative hypoxemia to the liver. However, the effect could not be demonstrated in protocol II, which induced a more severe IR injury.

MRI of female genital and pelvic organs during sexual arousal.

We utilized contrast enhanced magnetic resonance imaging (MRI) to delineate the anatomy of the female genital and pelvic organs during sexual arousal. Eleven healthy pre-menopausal women and eight healthy post-menopausal women underwent MRI of the pelvis while watching an erotic video. A 1.5 Tesla MR system was used to produce T1-weighted images following administration of MS-325, a gadolinium-based blood pool contrast agent. Selected structural dimensions and enhancement were measured prior to and during sexual arousal. In both pre- and post-menopausal subjects, vestibular bulb and labia minora width increased with arousal. Enhancement measurements increased in the bulb, labia minora and clitoris in both pre- and post-menopausal subjects, and in the vagina in pre-menopausal subjects. There were no marked changes in size or enhancement of the labia majora, urethra, cervix, or rectum during sexual arousal in pre- or post-menopausal subjects. Using MRI, we observed specific changes in the female genitalia and pelvic organs with sexual arousal, in both pre- and post-menopausal women. MRI can potentially provide detailed anatomical information in the assessment of female sexual function, particularly with regard to changes in blood flow.

Definitions of women's sexual dysfunction reconsidered: advocating expansion and revision.

In light of various shortcomings of the traditional nosology of women's sexual disorders for both clinical practice and research, an international multi-disciplinary group has reviewed the evidence for traditional assumptions about women's sexual response. It is apparent that fullfilment of sexual desire is an uncommon reason/incentive for sexual activity for many women and, in fact, sexual desire is frequently experienced only after sexual stimuli have elicited subjective sexual arousal. The latter is often poorly correlated with genital vasocongestion. Complaints of lack of subjective arousal despite apparently normal genital vasocongestion are common. Based on the review of existing evidence-based research, many modifications to the definitions of women's sexual dysfunctions are recommended. There is a new definition of sexual interest/desire disorder, sexual arousal disorders are separated into genital and subjective subtypes and the recently recognized condition of persistent sexual arousal is included. The definition of dyspareunia reflects the possibility of the pain precluding intercourse. The anticipation and fear of pain characteristic of vaginismus is noted while the assumed muscular spasm is omitted given the lack of evidence. Finally, a recommendation is made that all diagnoses be accompanied by descriptors relating to associated contextual factors and to the degree of distress.

National trends in condom use among at-risk heterosexuals in the united states.

Based on national level surveys, we examined data relevant to the United States' overall effort to prevent the spread of HIV among heterosexual adults. We examined changes in condom use among at-risk heterosexuals over the past decade. The observed increases over time in condom use across all heterosexual at-risk population segments are consistent with the observed (declines) trends in HIV and syphilis in the 1990s. These results and findings from prior studies suggest that U.S. efforts to facilitate condom use and contain HIV and related sexually transmitted disease (STD)-cofactors among adult at risk heterosexuals was succeeding over most of the 1990s. The absence of national level behavioral trend data after 1996, and the ambiguities of HIV spread suggest some caution in projecting trends into this century. National and local efforts need to be directed at sustaining behavioral change and conducting more rigorous studies on population trends in HIV/STD-related behaviors/pathogens.

Sexual abuse and sexual function: an examination of sexually relevant cognitive processes.

Participants were 61 sexually abused and 57 nonsexually abused women. The authors examined whether recent methodologies adopted from social-cognitive psychology might prove helpful in understanding the previously reported negative relation between childhood sexual abuse (CSA) and adult sexual function. In Part I, a card-sort task was used to explore potential differences between sexually abused and nonsexually abused women in the categorization of positive/negative self-information. In Part 2, sexually relevant information networks, believed to represent the way in which information is organized, accessed, and retrieved from memory, were compared. Sexually abused women differed from nonsexually abused women in the meanings they attributed to many sexuality-relevant concepts but not in how they compartmentalized positive/negative self-information. The findings provide insight into the cognitive processes by which CSA experiences might influence adult sexual function and provide a starting point for future research using this type of methodology.

The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function.

This article presents the development of a brief, self-report measure of female sexual function. Initial face validity testing of questionnaire items, identified by an expert panel, was followed by a study aimed at further refining the questionnaire. It was administered to 131 normal controls and 128 age-matched subjects with female sexual arousal disorder (FSAD) at five research centers. Based on clinical interpretations of a principal components analysis, a 6-domain structure was identified, which included desire, subjective arousal, lubrication, orgasm, satisfaction, and pain. Overall test-retest reliability coefficients were high for each of the individual domains (r = 0.79 to 0.86) and a high degree of internal consistency was observed (Cronbach's alpha values of 0.82 and higher) Good construct validity was demonstrated by highly significant mean difference scores between the FSAD and control groups for each of the domains (p < or = 0.001). Additionally, divergent validity with a scale of marital satisfaction was observed. These results support the reliability and psychometric (as well as clinical) validity of the Female Sexual Function Index (FSFI) in the assessment of key dimensions of female sexual function in clinical and nonclinical samples. Our findings also suggest important gender differences in the patterning of female sexual function in comparison with similar questionnaire studies in males.

The high prevalence of sexual concerns among women seeking routine gynecological care.

BACKGROUND: Sexuality is an important part of health, quality of life, and general wellbeing. Studies indicate that less than half of patients' sexual concerns are known by their physicians, and physicians are unaware of how common these sexual concerns are in their practices. Our objective was to determine the prevalence and type of sexual concerns among women seeking routine gynecological care. METHODS: We mailed the survey in waves. Of 1480 women seeking routine gynecological care from the departments of Family Practice and Obstetrics and Gynecology at Madigan Army Medical Center between August 1992 and January 1993, 964 responded. The main outcome measures were self-reported sexual concerns and their experiences with discussing these concerns with a physician. RESULTS: A A total of 98.8% of the women we surveyed reported one or more sexual concerns. The most frequently reported concerns were lack of interest (87.2%), difficulty with orgasm (83.3%), inadequate lubrication (74.7%), dyspareunia (71.7%), body image concerns (68.5%), unmet sexual needs (67.2%), and needing information about sexual issues (63.4%). More than half reported concerns about physical or sexual abuse, and more than 40% reported sexual coercion at some point in their lives. CONCLUSIONS: Our results suggest that sexual health concerns are prevalent for women seeking routine gynecological care. Sexual health inquiry should be a regular and important part of health care maintenance.

Report of the international consensus development conference on female sexual dysfunction: definitions and classifications.

PURPOSE: Female sexual dysfunction is highly prevalent but not well defined or understood. We evaluated and revised existing definitions and classifications of female sexual dysfunction. MATERIALS AND METHODS: An interdisciplinary consensus conference panel consisting of 19 experts in female sexual dysfunction selected from 5 countries was convened by the Sexual Function Health Council of the American Foundation for Urologic Disease. A modified Delphi method was used to develop consensus definitions and classifications, and build on the existing framework of the International Classification of Diseases-10 and DSM-IV: Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, which were limited to consideration of psychiatric disorders. RESULTS: Classifications were expanded to include psychogenic and organic causes of desire, arousal, orgasm and sexual pain disorders. An essential element of the new diagnostic system is the "personal distress" criterion. In particular, new definitions of sexual arousal and hypoactive sexual desire disorders were developed, and a new category of noncoital sexual pain disorder was added. In addition, a new subtyping system for clinical diagnosis was devised. Guidelines for clinical end points and outcomes were proposed, and important research goals and priorities were identified. CONCLUSIONS: We recommend use of the new female sexual dysfunction diagnostic and classification system based on physiological as well as psychological pathophysiologies, and a personal distress criterion for most diagnostic categories.

Ethnicity, desirable responding, and self-reports of abuse: a comparison of European- and Asian-ancestry undergraduates.

One thousand fifty-two (582 non-Asian, 470 Asian) university students were assessed regarding levels of physical abuse, emotional abuse, sexual abuse, neglect, and socially desirable responding. Differences between Asian-ancestry and European-ancestry students in self-reported incidence and expression of abuse were evaluated, as was gender and the relation between self-reported abuse and socially desirable responding. Asian-ancestry men and women reported higher levels of physical abuse, emotional abuse, and neglect than did their Euro-ancestry counterparts, and Euro-ancestry women reported a higher incidence of sexual abuse than did Asian-ancestry women. Across ethnicity, men reported higher levels of physical abuse and neglect but lower levels of sexual abuse than did women. Socially desirable responding was not related to measures of abuse. Findings are discussed in terms of cultural influences on child-rearing and disciplinary practices.

Relating body image to psychological and sexual functioning in child sexual abuse survivors.

Cognitive-affective body image variables and their relation to long-term psychological and sexual functioning were investigated in a community sample of 57 female adult child sexual abuse (CSA) survivors and 47 comparison subjects. The Body-Self Relations Questionnaire and the Body Esteem Scale were administered to assess cognitive-affective body image. Group comparisons indicated that, after controlling for actual weight status, survivors evaluated their health more negatively and reported less body esteem regarding their sexual attractiveness than comparison subjects. Body image variables related to health and sexual attractiveness significantly explained variance on symptom measures that reflect the diverse CSA long-term sequelae. Results suggest the need for careful assessment of body image disturbances and the development of effective interventions targeting body image in the treatment of CSA survivors.

Psychophysiological models of female sexual response.

Psychophysiology provides a methodology and a model for evaluating physiological and psychological (cognitive-affective) components of sexuality in a relatively controlled laboratory setting. Laboratory responses can then be correlated with key sexual or nonsexual self-reported behaviors, thoughts and feelings occurring in the person's daily environment. Given the fact that human sexual response is the result of a complex interaction of psychosocial and physiological factors, a psychophysiological model provides one valuable inroad to exploring and analyzing sexual response patterns. The following comments briefly evaluate the current status of the use of this model as it applies to female sexual response.

Ethical and cultural concerns in sexual function assessment.

The ethical and cultural issues accompanying sex research methods are rarely discussed. The present remarks briefly examine three previously described ethical principles--respect for people, beneficence and justice--as they might relate to sexual dysfunction assessment in clinical trials. Given the fact that sexuality is a social behavior and the outcome measures are reliant on some form of self report, there are specific pressures on investigators to conduct research assessment that respects ethical principles and cultural values. Examples with respect to screening criteria and participant selection are discussed. Recommendations include: (a) excluding participants with selected sexual and non-sexual diagnoses, psychosocial behaviors and habits; (b) including proportional ethnic groups as well as non-heterosexual participants; and (c) considering the couple, rather than just an individual, as study subjects who each require medical and psychosocial screening, assessment, and informed consent.