Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial).

OBJECTIVE: To compare adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy. DESIGN: Parallel group, 1:1 single-centre single-blinded randomised trial, designed as non-inferiority study with a margin of 15%. SETTING: Belgian teaching hospital. POPULATION: Non-pregnant non-virgin women with an intact uterus and without obliteration of the pouch of Douglas scheduled to undergo removal of an adnexal mass assessed to be benign on ultrasound by IOTA criteria. METHODS: Randomisation to laparoscopy (control group) or vNOTES (experimental group). Stratification according to adnexal size. Blinding of participants and outcome assessors by sham incisions. MAIN OUTCOME MEASURES: The primary outcome measure was adnexectomy by the allocated technique. Secondary outcomes included duration of surgery, pain scores and analgesics used, quality of life and adverse events. RESULTS: We randomly assigned 67 participants (34 to the vNOTES group and 33 to the laparoscopy group). The primary end point was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the laparoscopy group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 13%, which is below the predefined non-inferiority margin of 15%. The secondary outcomes demonstrated a shorter duration of surgery, lower pain scores, lower total dose of analgesics and a trend for more adverse events in the vNOTES group. CONCLUSIONS: vNOTES is non-inferior to laparoscopy for a successful adnexectomy without conversion. vNOTES allowed shorter operating times and less postoperative pain but there was a trend for more adverse events.

Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial.

OBJECTIVE: To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure. DESIGN: Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%. SETTING: Belgian teaching hospital. POPULATION: Women aged 18-70 years scheduled to undergo hysterectomy for benign indications. METHODS: Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors. MAIN OUTCOME MEASURES: The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes. RESULTS: We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004. CONCLUSIONS: vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting. TWEETABLE ABSTRACT: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.

Effect of laparoscopic surgery for moderate and severe endometriosis on depression, relationship satisfaction and sexual functioning: comparison of patients with and without bowel resection.

STUDY QUESTION: Is there a difference between women with endometriosis who underwent laparoscopic surgery with bowel resection or without bowel resection regarding depressive symptoms, relational adjustment and sexual functioning? SUMMARY ANSWER: Radical surgery for endometriosis in both groups improved the levels of depression and sexual functioning, but only the bowel resection patients showed improvements in relationship satisfaction. WHAT IS KNOWN ALREADY?: The frequent pain symptoms in endometriosis patients can have an impact on psychological issues, relationships and sexual functioning. There are no data available on depression and relationship adjustment after endometriosis surgery. Sexual dysfunction problems have been described after bowel resection for rectal cancer, but no data are available for endometriosis surgery. STUDY DESIGN, SIZE, DURATION: This prospective cohort study included 203 consecutive women operated at the Leuven University Fertility Center (LUFC) between 1 September 2006 and 30 September 2008 for moderate (n = 67) or severe (n = 136) endometriosis. The preoperative response rate was respectively 84% in the bowel resection group and 79% in the no bowel resection group. PARTICIPANTS, SETTING, METHODS: The beck depression inventory (BDI) measured depression, the dyadic adjustment scale (DAS) measured relationship satisfaction and the short sexual functioning scale (SSFS) measured sexual functioning before and 6, 12 and 18 months after women had laparoscopic surgery at the LUFC, a tertiary referral centre for fertility exploration, treatment and surgery. MAIN RESULTS AND THE ROLE OF CHANCE: Both groups had better post-operative outcomes when compared with the preoperative assessments. Mean BDI and DAS levels were comparable with the normal population. Overall assessment points, the bowel resection patients had better outcomes for DAS (P < 0.05) and SSFS 'arousal' (P < 0.05) than the no bowel resection patients. At 6 months after the operation, when compared with the no bowel resection group, the bowel resection group reported lower mean levels of BDI (P < 0.05), a lower incidence of SSFS 'pain during intercourse' and 'orgasm problems' (P < 0.05), and a lower proportion of patients with severe orgasm problems (P < 0.05). The data show that radical but fertility sparing surgery, with or without bowel resection, for the treatment of endometriosis results in comparable and good psychological outcomes concerning depression levels, relationship satisfaction and sexual functioning. LIMITATIONS, REASONS FOR CAUTION: Although the initial response rate was good, response dropped over time and was significantly higher for bowel resection patients compared with the no bowel resection patients (P = 0.05). A responder/non-responder analysis for the whole study population showed no significant differences concerning pain problems. This reduces the possible risk of (positive) bias in the results. WIDER IMPLICATIONS OF THE FINDINGS: Endometriosis is a complex condition and the focus should not be on a one-dimensional end-organ gynaecological outcome, but should take into account the role of psychological factors in pain-related outcome. To this end, more prospective data are needed on sexual functioning and psychological outcomes.

Reasons for dropout in infertility treatment.

BACKGROUND: The objective of this study was to explore the reasons why couples discontinue fertility treatment. METHODS: A retrospective exploratory study was performed at the Leuven University Fertility Centre, a university hospital-based fertility center. Women who discontinued treatment between September 2000 and December 2001 were contacted in 2004-2005 by telephone for a standardized interview which covered 9 dropout reasons. For each reason, its importance on the decision to stop treatment was measured on an 11-point Likert scale. RESULTS: On average, psychological burden (x = 5.96) had the highest impact on the decision to stop treatment followed by physical burden (x = 4.48) and female age (x = 3.64). Perceived lack of staff expertise (x = 1.84), negative impact on social contacts (x = 2.12) and financial burden (x = 2.16) had the lowest impact on the decision to stop treatment. Longer duration of infertility was significantly positively correlated with a higher rating of physical burden as a reason to discontinue treatment (r = 0.48; p < 0.05). DISCUSSION: On average, psychological burden appears to be most frequently named as the number one reason to discontinue infertility treatment, whereas financial burden had the lowest impact. Longer duration of infertility is associated with more externalizing reasons to discontinue treatment.

Sexual and psychological functioning in women after pelvic surgery for gynaecological cancer.

Pelvic surgery for gynecological cancer can affect sexuality through a number of anatomical, physiological and psychological mechanisms. We aimed to examine the prevalence of sexual dysfunction and psychological functioning in women who underwent pelvic surgery for gynecological cancer. Fifty women who underwent pelvic surgery for vulvar, cervical or endometrial cancer in a gynecological oncology unit completed questionnaires evaluating marital satisfaction (DAS), depression (BDI-II) and sexual functioning (SSFS and an in-house Specific Sexual Problems Questionnaire). Medical records were used to obtain disease-specific data. The control group consisted of 39 healthy age-matched control women attending an outpatient screening clinic. Significantly more women with gynaecological cancer than controls reported sexual problems (83 vs 20%), including decreased desire (76 vs 14%) and impaired vaginal lubrication (42 vs 9%). Pelvic surgery was specifically related to changed intensity of orgasm (43%), reduced vaginal sensitivity (38%), vaginal elasticity (30%), superficial dyspareunia (27%), vaginal narrowing (26%) and shortening (22%). Although no significant differences were found between either group for depression (17% vs 13%) or total quality of the partner relationship, women with a history of gynecological cancer reported significant lower marital cohesion. These results indicate that although the psychological adjustment of women who underwent pelvic surgery seems to be satisfactory, they seem to be at risk for sexual dysfunctions.

Compliance with antidepressants in a primary care setting, 1: Beyond lack of efficacy and adverse events.

BACKGROUND: Treatment guidelines recommend antidepressant treatment be continued for at least 6 months to ensure maximal improvement and to prevent relapse. Naturalistic studies show that the average length of treatment is shorter than 6 months and that dropout rates are high. Factors leading patients to discontinuation of therapy are not well understood. This study investigates when and why patients stop treatment and whether they inform their doctors. METHOD: Patients (N = 272) receiving antidepressant therapy due to an episode of major depressive disorder (DSM-IV) were asked to complete an antidepressant compliance questionnaire. Patients were then telephoned monthly while they continued on antidepressant therapy, up to 6 months. During each call, patients were asked standard questions. RESULTS: By endpoint, 53% of patients had discontinued antidepressant treatment. The most common reason given was "feeling better." However, different dropout reasons were prevalent at different times after initiation of therapy. Overall, 24% of the patients did not inform their physician about stopping the antidepressant medication. The likelihood of patients' informing their physicians differed according to the patients' reasons for discontinuation and according to the patients' perceptions of their relationship with their physicians. CONCLUSION: These results provide new guidelines for improving compliance. Strategy should be adapted to the stage of treatment, as patients' reasons for discontinuation vary as treatment progresses. The attitude of the physician and the information provided by the physician significantly influence whether patients inform the physician when they discontinue antidepressant therapy.

Compliance with antidepressants in a primary care setting, 2: the influence of gender and type of impairment.

BACKGROUND: DSM-IV diagnosis of major depressive disorder includes a requirement that symptoms result in significant clinical distress or impairment. This criterion is difficult to assess and is often overlooked. This study examines the use of the Sheehan Disability Scale as a possible method of assessing impairment, as well as the relationship between functioning and discontinuation of antidepressant medication. METHOD: Patients (N = 272) receiving antidepressant therapy due to an episode of major depressive disorder were asked to complete an antidepressant compliance questionnaire. Patients were telephoned monthly while they continued on antidepressant therapy, up to 6 months. During each call, the Sheehan Disability Scale was administered. RESULTS: Of patients referred to this study, 94.8% met DSM-IV criteria of at least 5 symptoms of major depressive disorder. Most patients had initial scores ranging from 5 to 8 on all 3 Sheehan disability subscales (occupational, social, and family functioning); 72% of patients had at least moderate impairment (scores > or = 4) on all 3 subscales. After 8 weeks of treatment, 42% of patients had scores < 4 on all 3 subscales (recovery); after 24 weeks, 64% of patients had scores < 4 on all 3 subscales. Dropout risk in men was related to improvement in occupational, social, and family functioning, whereas dropout risk in women was related only to improvement in family functioning. CONCLUSION: The Sheehan Disability Scale can be valuable in assessing impairment and thus in correctly diagnosing major depressive disorder. We suggest that scores of 4 or more (moderate impairment) on all 3 subscales indicate sufficient impairment for a strict diagnosis of major depressive disorder. Functional symptoms continued to improve for up to 24 weeks on antidepressant therapy, suggesting 6 months or more of therapy is necessary for maximum functional improvement. Premature discontinuation of antidepressant therapy is more likely to occur in women who experience significant improvement in family functioning or men who experience significant improvement in any functional area.

Sexual functioning in a population-based study of men aged 40-69 years: the good news.

The aim of the study was to provide cross-sectional data on age-related sexual functioning of men aged 40-69 y. The study was a randomised age-stratified community-based sample survey. In all, 799 men from two comparable middle-sized areas of Belgium participated in the study. Trained male nurses visited each participant at home and conducted a structured interview during which the participants filled out the International Index of Erectile Function (IIEF). The main outcome measures were scores on the IIEF questionnaire at item level. This study showed that 69% of the sample attempted to have intercourse during the past 4 weeks with an age-related increase in the proportion of sexually inactive men (11% at age 40-49 y; 25% at age 50-59 y; 52% at age 60-69 y; P=0.0001). Almost 90% of sexually active men reported to be able to get and keep an erection until completion of intercourse, to ejaculate with a feeling of orgasm, and reported to be satisfied with their sexual partner relation and their overall sex life. About 75% of sexually active men reported to be (very) highly confident about their erectile functioning. Only 15% of sexually inactive men reported a high to very high frequency and strong to very strong level of sexual desire. Whereas 26% still reported high to very high confidence in their erectile capacity, 34% reported to be moderately to (very) satisfied with their sexual life. This study showed that sexuality still matters at middle to high age and that it deserves to be regarded as an important and continuing aspect of the overall adaptation to getting older.

Trazodone: a double-blind, placebo-controlled, randomized study of its effects in patients with erectile dysfunction without major organic findings.

UNLABELLED: This study examined the efficacy of trazodone 200 mg/day in patients with erectile dysfunction (ED) without major organic findings. PATIENTS AND METHODS: Thirty-four patients with ED without major organic findings entered a double-blind, placebo-controlled, randomized two-centre trial comparing placebo and trazodone 200 mg/day. After a 2 week treatment-free, baseline period eligible patients entered a 4 week treatment-phase. Nocturnal erectile activity was measured before and after treatment by Rigiscan Plus. Sexual desire, quality of partner relation and depressive symptomatology were assessed with the derogatis sexual functioning inventory (DSFI), the dyadic adjustment scale (DAS) and the Hamilton depression rating scale (HDRS), respectively. Sexual function during the study period was assessed with patient diaries. Compliance was measured by trazodone serum concentrations. There were no significant differences between trazodone and placebo in total erection duration, change in sexual desire, report of morning erections or psychometric scales, except for the HDRS. Trazodone serum levels indicated that half of the patients were not compliant. In conclusion, Trazodone 200 mg/day has no effect on sexual function in men with ED without major organic findings and non-compliance was an important issue in the present study.

Psychological impact of endometrial monitoring in tamoxifen-treated postmenopausal breast cancer patients.

In view of the higher incidence of endometrial pathology in tamoxifen-treated breast cancer patients, it has been recommended that endometrial surveillance be performed on these women by means of transvaginal sonography. Our study investigated how breast cancer patients experience the endometrial surveillance and which personality factors influence this experience. We also studied compliance with the recommended examination. Fifty-three consecutive asymptomatic postmenopausal breast cancer patients who had taken tamoxifen for at least 6 months were included. Our results show that 23% of the women felt very anxious just before the examination. One woman in five evaluated the procedure as annoying, unpleasant, invasive and awkward, but only 3% found it really unacceptable. Difficulties in coping with mastectomy as well as anxiety negatively affected the experience of the examination. One in six women were doubtful about their ability to comply with such an examination in the future. Women who have difficulties in coming to terms with the mastectomy, anxious women, and women with a low tolerance towards common medical procedures are at especial risk of becoming dropouts. Suggestions are made for developing strategies that might improve these women's compliance.

Sexual functioning in women after mastectomy versus breast conserving therapy for early-stage breast cancer: a prospective controlled study.

INTRODUCTION: Breast cancer (BC) and/or its treatments may affect sexual functioning based on physiological and psychosocial mechanisms. The aim of this study was to prospectively investigate sexual adjustment of BC patients during a follow-up period of one year after mastectomy (ME) or breast conserving therapy (BCT). METHODS: In this prospective controlled study, women with BC and an age-matched control group of healthy women completed the Beck Depression Inventory Scale, World Health Organization 5 Well-being scale, Body Image Scale, EORTC QLQ questionnaire, Dyadic Adjustment Scale, Short Sexual Functioning Scale and Specific Sexual Problems Questionnaire to assess various aspects of sexual and psychosocial functioning before surgery, six months and one year after surgical treatment. RESULTS: In total, 149 women with BC and 149 age-matched healthy controls completed the survey. Compared to the situation before surgery, significantly more BCT women reported problems with sexual arousal six months after surgery and significantly more women of the ME group reported problems with sexual desire, arousal and the ability to achieve an orgasm six months and one year after surgery. While in comparison with healthy controls, no significant differences in sexual functioning were found after BCT surgery, significantly more women who underwent ME reported problems with sexual desire, arousal, the ability to achieve an orgasm and intensity of the orgasm. CONCLUSIONS: Although little differences were seen in sexual functioning in the BCT group during prospective analyses and in comparison with healthy controls, analyses revealed that women who underwent a ME were at risk for post-operative sexual dysfunctions.

Pheromones and their effect on women's mood and sexuality.

Pheromones are substances which are secreted to the outside by an individual and received by a second individual of the same species. Many examples exist in animals but their role in humans remains uncertain since adults have no functioning vomeronasal organ, which processes pheromone signals in animals. Yet pheromones can be detected by the olfactory system although humans under develop and underrate their smelling sense. Pheromones may be present in all bodily secretions but most attention has been geared toward axillary sweat which contains the odorous 16-androstenes. One of these steroidal compounds, androstadienone, is present at much higher concentrations in male sweat and can be detected by women, albeit with wide variation in sensitivity. Upper-lip application of a pharmacological dose of androstadienonein women results in improved mood and heightened focus - particularly to capture emotional information. A positive mood is known to facilitate women's sexual response, and -increased focus improves sexual satisfaction. Indeed, some studies showed a beneficial effect of androstadienone on sexual desire and arousal. However, these effects were dependent on the context of the experiment, for example, on the presence of a male attendant. Pheromones may also play a role in mate selection which is "disassortative" regarding the human leukocyte antigen (HLA)-genotype. Preliminary evidence suggests that exposure to androstadienone in women promotes attractiveness ratings of potential mates. In conclusion, some data indicate that 16-androstene pheromones, in particular androstadienone, play a beneficial role in women's mood, focus and sexual response, and perhaps also in mate selection.

Sexuality in people with a lower limb amputation: a topic too hot to handle?

PURPOSE: The purpose of this study was to analyze whether, and by whom sexuality is discussed in amputation departments. The focus was on whether professionals received questions about sexuality from their patients with a lower limb amputation and whether they addressed sexuality themselves, as well as on the knowledge and comfort level, approach and attitudes toward sexuality of these professionals. METHOD: An online questionnaire, including questions on self-perceived sexological competence and the Knowledge, Comfort, Approach and Attitudes towards Sexuality Scale. RESULTS: Seventy-eight percent of the professionals had not received questions about sexuality from their patients and 67% had not addressed sexuality. Self-perceived knowledge about sexuality and self-perceived ability to recognize sexual problems increased the odds of receiving a question about sexuality and the odds of addressing this issue. CONCLUSIONS: Sexuality is rarely discussed by professionals in the amputation department. It is, however, the responsibility of the professional to do so. By addressing sexuality in a systematic way and discussing this as a common topic professionals "give permission" to patients and other team members to discuss eventual sexual problems or concerns. Therefore, the professionals' self-perceived sexological competence and feeling of comfort with the topic of sexuality need to be increased. Implications for Rehabilitation Sexuality is rarely discussed by professionals in the amputation department, even though sexual problems do occur in patients with a lower limb amputation (LLA). By addressing sexuality in a systematic way and discussing this as a common topic professionals "give permission" to patients and other team members to discuss eventual sexual problems or concerns. Our study shows that self-perceived knowledge about sexuality and self-perceived ability to recognize sexual problems increases the odds of receiving a question about sexuality and the odds of addressing this issue. Investing in courses that focus on increasing the knowledge and feeling of comfort concerning sexuality of professionals working with people with a LLA is therefore of important value.

A systematic review of sperm donors: demographic characteristics, attitudes, motives and experiences of the process of sperm donation.

BACKGROUND This systematic review aimed first to integrate the current body of knowledge on the demographic, institutional and psychosocial information on sperm donors, and second to provide insight into the actual experiences of men who donate and the attitudes towards potential donation. METHODS Electronic databases (PUBMED, CINAHL, PsycINFO, Embase and Web of Science) were searched with no date restriction using a specific search strategy followed by a snowball strategy. English language peer-reviewed abstracts and full texts were screened for eligibility and the risk of bias was assessed with 15 criteria. Eligibility, quality assessments and data extraction were performed by two independent researchers, resolving disagreement by discussion. RESULTS The initial search retrieved 857 studies and after quality assessment, 29 studies were retained for data extraction. Data from nine countries were obtained. The review synthesis revealed differences and similarities between actual and potential sperm donors on demographic characteristics, financial compensation and attitudes towards anonymity, disclosure and providing information to potential offspring. A number of methodological shortcomings have been identified in the studies investigating sperm donors. CONCLUSIONS Institutional factors (such as recruitment procedures, altruism versus compensation of sperm donors, anonymity versus open-identity donation) and the impact of changing legislation have largely dominated the studies on sperm donation. Furthermore, studies from countries with a bias towards white Western ideology and interpretation were over-represented. This has resulted in a profile of potential and actual sperm donors in terms of demographics, recruitment strategies, motivation for donation and attitudes regarding anonymity, disclosure, recipients and offspring. However, the psychosocial needs and experiences of the donor, and their follow-up and counselling are largely neglected. This review has identified key issues to inform current practice and the development of pathways of care for sperm donors that reflect the multidimensional nature of sperm donation.

Diabetes mellitus and female sexuality: a review of 25 years' research.

Diabetes mellitus may cause debilitating somatic complications and a high psychosocial burden. Impaired sexual function (erectile dysfunction) is a well-established complication in men. Does diabetes also have an effect on sexuality of women? Since the first publication in 1971, only 15 studies in this area have been published and their results are contradictory. The purpose of this article is to offer a review of these results. As a conclusion, a new hypothesis on the specific influence of diabetes on female sexuality and suggestions for further research are formulated.

Coping with infertility: a body-mind group intervention programme for infertile couples.

BACKGROUND: The recognition of the distressing character of infertility diagnosis and treatment has led to the development of several psychosocial interventions for infertile couples. At the Leuven University Fertility Centre, a body-mind marital group intervention was developed to help infertile couples cope with the distress related to infertility. METHODS AND RESULTS: This treatment programme was originally adapted from a mind-body approach, but integrated concepts and techniques from body-oriented therapy, art therapy and multi-family group therapy. In this paper, the therapeutic foundations, treatment goals and practical implications of the mind-body marital group intervention are outlined. Further, the treatment procedure is explained in detail and illustrated by clinical vignettes. CONCLUSIONS: Although the first clinical impressions about the usefulness of the body-mind group programme in fertility clinics seem promising, further research is needed to assess its effectiveness.