Music from Noise-Canceling Headphones Is Beneficial against Anxiety in Male Bladder Cancer Patients Undergoing Follow-Up Cystoscopy: A Prospective Randomized Trial.

INTRODUCTION: Bladder cancer, with a greater incidence in males than in females, requires frequent cystoscopies. We aimed to evaluate the effect of music played through noise-canceling headphones on male bladder cancer patients during follow-up cystoscopy. METHODS: A total of 160 male bladder cancer patients undergoing follow-up flexible cystoscopy were randomly divided into the noise-canceling headphones without music group and the noise-canceling headphones with music group (groups 1 and 2, respectively; n = 80 per group). The patients' clinical characteristics were examined, and objective and subjective measurements were compared before and after cystoscopy. The primary outcomes that were evaluated included the visual analog scale (VAS, 0-10) and the state-trait anxiety inventory (STAI, 20-80). Other outcomes, including vital signs and scores for assessing satisfaction and the willingness to repeat the procedure, were also examined. RESULTS: The characteristics of the patients in groups 1 and 2, and their pre-cystoscopy status, did not differ significantly. Although post-cystoscopy vital signs for the objective parameters and VAS pain scores were similar between the groups, subjective parameters were not. When compared with group 1, post-cystoscopy STAI-state scores were significantly lower in group 2, whereas patients' satisfaction scores and the willingness to repeat the procedure were significantly higher in group 2 (p = 0.002, 0.001, and 0.001, respectively). Additionally, in group 2, STAI-state scores changed significantly after the procedure when compared with before the procedure (p = 0.002). CONCLUSION: Providing music to male bladder cancer patients through noise-canceling headphones was found to reduce anxiety during cystoscopy and to improve patient satisfaction and willingness to undergo repeat cystoscopy.

Altered brain morphology and functional connectivity in postmenopausal women: automatic segmentation of whole-brain and thalamic subnuclei and resting-state fMRI.

The transition to menopause is associated with various physiological changes, including alterations in brain structure and function. However, menopause-related structural and functional changes are poorly understood. The purpose of this study was not only to compare the brain volume changes between premenopausal and postmenopausal women, but also to evaluate the functional connectivity between the targeted brain regions associated with structural atrophy in postmenopausal women. Each 21 premenopausal and postmenopausal women underwent magnetic resonance imaging (MRI). T1-weighted MRI and resting-state functional MRI data were used to compare the brain volume and seed-based functional connectivity, respectively. In statistical analysis, multivariate analysis of variance, with age and whole brain volume as covariates, was used to evaluate surface areas and subcortical volumes between the two groups. Postmenopausal women showed significantly smaller cortical surface, especially in the left medial orbitofrontal cortex (mOFC), right superior temporal cortex, and right lateral orbitofrontal cortex, compared to premenopausal women (p < 0.05, Bonferroni-corrected) as well as significantly decreased functional connectivity between the left mOFC and the right thalamus was observed (p < 0.005, Monte-Carlo corrected). Although postmenopausal women did not show volume atrophy in the right thalamus, the volume of the right pulvinar anterior, which is one of the distinguished thalamic subnuclei, was significantly decreased (p < 0.05, Bonferroni-corrected). Taken together, our findings suggest that diminished brain volume and functional connectivity may be linked to menopause-related symptoms caused by the lower sex hormone levels.

Early Detection of Alzheimer's Disease in Postmenopausal Women Using Thalamic Subnuclear Volumetry.

Alzheimer's disease (AD) and aging are intrinsically interconnected with each other and are mediated by molecular, cellular, and biological systems. In particular, a specific pattern of brain volume atrophy is the most profound risk factor for cognitive impairment, including AD, that is directly linked to aging. Thus, this study aimed to investigate knowledge on the early detection of AD in postmenopausal women, focusing on the volume changes of the subcortical regions, including the thalamic subnuclei, in women with AD vs. postmenopausal women. Twenty-one women with AD and twenty-one postmenopausal women without AD underwent magnetic resonance imaging (MRI). Women with AD showed significantly reduced volumes in the hippocampus, thalamus, and amygdala compared with postmenopausal women (p < 0.05, FWE-corrected). After adjustments for age, the right hippocampal volume was found to be significantly lower in the women with AD, but the volumes of the thalamus and amygdala were relatively unaffected. The women with AD exhibited significantly reduced volume in the right laterodorsal nucleus of the thalamus compared with the postmenopausal women (p < 0.05, Bonferroni-corrected). Our findings suggest that the reduced volume of both the right laterodorsal thalamic nucleus and right hippocampus may serve as a potential biomarker for the early detection of AD in postmenopausal women.

Management of Male Infertility with Coexisting Sexual Dysfunction: A Consensus Statement and Clinical Recommendations from the Asia-Pacific Society of Sexual Medicine (APSSM) and the Asian Society of Men's Health and Aging (ASMHA).

Male infertility (MI) and male sexual dysfunction (MSD) can often coexist together due to various interplay factors such as psychosexual, sociocultural and relationship dynamics. The presence of each form of MSD can adversely impact male reproduction and treatment strategies will need to be individualized based on patients' factors, local expertise, and geographical socioeconomic status. The Asia Pacific Society of Sexual Medicine (APSSM) and the Asian Society of Men's Health and Aging (ASMHA) aim to provide a consensus statement and practical set of clinical recommendations based on current evidence to guide clinicians in the management of MI and MSD within the Asia-Pacific (AP) region. A comprehensive, narrative review of the literature was performed to identify the various forms of MSD and their association with MI. MEDLINE and EMBASE databases were searched for the following English language articles under the following terms: "low libido", "erectile dysfunction", "ejaculatory dysfunction", "premature ejaculation", "retrograde ejaculation", "delayed ejaculation", "anejaculation", and "orgasmic dysfunction" between January 2001 to June 2022 with emphasis on published guidelines endorsed by various organizations. This APSSM consensus committee panel evaluated and provided evidence-based recommendations on MI and clinically relevant MSD areas using a modified Delphi method by the panel and specific emphasis on locoregional socio-economic-cultural issues relevant to the AP region. While variations exist in treatment strategies for managing MI and MSD due to geographical expertise, locoregional resources, and sociocultural factors, the panel agreed that comprehensive fertility evaluation with a multidisciplinary management approach to each MSD domain is recommended. It is important to address individual MI issues with an emphasis on improving spermatogenesis and facilitating reproductive avenues while at the same time, managing various MSD conditions with evidence-based treatments. All therapeutic options should be discussed and implemented based on the patient's individual needs, beliefs and preferences while incorporating locoregional expertise and available resources.

The relationship between depressive mood and subjective health in centenarians and near-centenarians: a cross-sectional study from Korean centenarian cohort.

BACKGROUND: With the rapid increase in population longevity, more clinical attention is being paid to the overall health of long-lived people, especially centenarians. Subjective health, which is the perception of one's health status, predicts both mortality and declining physical function in older adults. The purpose of this study was to investigate the factors related to subjective health among centenarians and near-centenarians (ages ≥95) living in a rural area of South Korea. METHODS: A total of 101 participants were enrolled from four different regions (Gurye, Gokseong, Sunchang, and Damyang), known as the Longevity Belt in Korea. Variables assessing physical and mental health, including the results of blood tests, were examined. Factors associated with good subjective health were identified with logistic regression analysis. RESULTS: Fifty-six participants (59.6%) were subjectively healthy among the centenarians and near-centenarians. Logistic regression analysis revealed that depressive mood was the only factor associated with subjective health and was negatively correlated. The regression model explained 39% of the variance in subjective health. CONCLUSIONS: These findings emphasize the importance of mental health at very advanced ages. Because depressive mood negatively correlates with subjective health, more attention is needed to prevent and manage mood symptoms of people of advanced ages, including centenarians.

Clinical recommendations on penile reconstructive and prosthetic surgery: a consensus statement from the Asia-Pacific Society of Sexual Medicine.

Introduction: Penile reconstructive and prosthetic surgery remains a highly specialized field where potential complications can be devastating, and unrealistic patient expectations can often be difficult to manage. Furthermore, surgical practice can vary depending on locoregional expertise and sociocultural factors. Methods: The Asia Pacific Society of Sexual Medicine (APSSM) panel of experts reviewed contemporary evidence regarding penile reconstructive and prosthetic surgery with an emphasis on key issues relevant to the Asia-Pacific (AP) region and developed a consensus statement and set of clinical practice recommendations on behalf of the APSSM. The Medline and EMBASE databases were searched using the following terms: "penile prosthesis implant," "Peyronie's disease," "penile lengthening," "penile augmentation," "penile enlargement," "buried penis," "penile disorders," "penile trauma," "transgender," and "penile reconstruction" between January 2001 and June 2022. A modified Delphi method was undertaken, and the panel evaluated, agreed, and provided consensus statements on clinically relevant penile reconstructive and prosthetic surgery, namely (1) penile prosthesis implantation, (2) Peyronie's disease, (3) penile trauma, (4) gender-affirming (phalloplasty) surgery, and (5) penile esthetic (length and/or girth enlargement) surgery. Main outcome measures: Outcomes were specific statements and clinical recommendations according to the Oxford Centre for Evidence-Based Medicine, and if clinical evidence is lacking, a consensus agreement is adopted. The panel provided statements on clinical aspects of surgical management in penile reconstructive and prosthetic surgery. Results: There is a variation in surgical algorithms in patients based on sociocultural characteristics and the availability of local resources. Performing preoperative counseling and obtaining adequate informed consent are paramount and should be conducted to discuss various treatment options, including the pros and cons of each surgical intervention. Patients should be provided with information regarding potential complications related to surgery, and strict adherence to safe surgical principles, preoperative optimization of medical comorbidities and stringent postoperative care are important to improve patient satisfaction rates. For complex patients, surgical intervention should ideally be referred and performed by expert high-volume surgeons to maximize clinical outcomes. Clinical implications: Due to the uneven distribution of surgical access and expertise across the AP region, development of relevant comprehensive surgical protocols and regular training programs is desirable. Strengths and Limitations: This consensus statement covers comprehensive penile reconstructive and prosthetic surgery topics and is endorsed by the APSSM. The variations in surgical algorithms and lack of sufficient high-level evidence in these areas could be stated as a limitation. Conclusion: This APSSM consensus statement provides clinical recommendations on the surgical management of various penile reconstructive and prosthetic surgeries. The APSSM advocates for surgeons in AP to individualize surgical options based on patient condition(s) and needs, surgeon expertise, and local resources.

Effects of retinoid-loaded hyaluronic acid nanomicelles on vaginal epithelium in a murine menopause model.

PURPOSE: This study aimed to develop hyaluronic acid (HA)-based, retinoic acid (RA)-containing nanomicelles and to investigate the effects of these newly developed nanomicelles on regeneration of the vaginal epithelium and aquaporin 3 (AQP3) expression in a murine menopause model. MATERIALS AND METHODS: The HA-based, RA-loaded nanomicelles were developed, and the RA-loading rate, encapsulation efficiency, and hydrodynamic diameter were measured. Female BALB/c mice (8 weeks; n=30) were divided into control and experimental groups. Menopause was established in the experimental group by removing both ovaries. The experimental group was further divided into an ovariectomy group, an HA-C18 vehicle group, and an HA-C18-RA group (2.5 µg per mouse); vaginal administration of HA-C18 or HA-C18-RA was performed once daily. After 4 weeks of treatment, murine vaginal tissue was removed, and histological analysis was performed. RESULTS: Three drug-loaded nanomicelles were synthesized: the RA content in HA-C18-RA-10, HA-C18-RA-20, and HA-C18-RA-30 was 3.13%, 2.52%, and 16.67%, respectively, and the RA encapsulation efficiency was 95.57%, 83.92%, and 93.24%, respectively. In the experimental versus control group, serum estrogen levels were significantly reduced, and the vaginal mucosal epithelial layer was significantly thinner. After 4 weeks of treatment, the thickness of the vaginal mucosal epithelial layer and AQP3 expression was increased in the HA-C18-RA group compared with the HA-C18 vehicle group. CONCLUSIONS: The newly developed HA-based nanomicelles containing RA resulted in vaginal epithelial recovery and increased AQP3 expression. The results may contribute to the development of functional vaginal lubricants or moisturizers for the treatment of vaginal dryness.

Increased Hippocampal-Inferior Temporal Gyrus White Matter Connectivity following Donepezil Treatment in Patients with Early Alzheimer's Disease: A Diffusion Tensor Probabilistic Tractography Study.

The incidence of Alzheimer's disease (AD) has been increasing each year, and a defective hippocampus has been primarily associated with an early stage of AD. However, the effect of donepezil treatment on hippocampus-related networks is unknown. Thus, in the current study, we evaluated the hippocampal white matter (WM) connectivity in patients with early-stage AD before and after donepezil treatment using probabilistic tractography, and we further determined the WM integrity and changes in brain volume. Ten patients with early-stage AD (mean age = 72.4 ± 7.9 years; seven females and three males) and nine healthy controls (HC; mean age = 70.7 ± 3.5 years; six females and three males) underwent a magnetic resonance (MR) examination. After performing the first MR examination, the patients received donepezil treatment for 6 months. The brain volumes and diffusion tensor imaging scalars of 11 regions of interest (the superior/middle/inferior frontal gyrus, the superior/middle/inferior temporal gyrus, the amygdala, the caudate nucleus, the hippocampus, the putamen, and the thalamus) were measured using MR imaging and DTI, respectively. Seed-based structural connectivity analyses were focused on the hippocampus. The patients with early AD had a lower hippocampal volume and WM connectivity with the superior frontal gyrus and higher mean diffusivity (MD) and radial diffusivity (RD) in the amygdala than HC (p < 0.05, Bonferroni-corrected). However, brain areas with a higher (or lower) brain volume and WM connectivity were not observed in the HC compared with the patients with early AD. After six months of donepezil treatment, the patients with early AD showed increased hippocampal-inferior temporal gyrus (ITG) WM connectivity (p < 0.05, Bonferroni-corrected).

Mean platelet volume is the most valuable hematologic parameter in differentiating testicular torsion from epididymitis within the golden time.

Background: We aimed to assess the diagnostic value of hematologic parameters in the differential diagnosis of testicular torsion and epididymitis within and after the golden time. Methods: We retrospectively reviewed the records of 250 patients aged <25 years who were diagnosed with epididymitis (n=119) or testicular torsion (n=131). The characteristics and hematologic parameters of patients in the two groups were analyzed. Receiver operating characteristic (ROC) curves were used to assess the validity of hematologic parameters as differential diagnostic tools with respect to the golden time (defined as 6 h of symptom duration). Further, we evaluated the predictive factors associated with orchiectomy in patients with testicular torsion. Results: The mean patient age was 14.4 years. Among patients with testicular torsion, 91.40% (53 of 58) underwent detorsion and orchiopexy within the golden time, whereas only 27.40% (20 of 73) of the affected testes were preserved after the golden time. Within the golden time, mean platelet volume (MPV) seemed to be the most valuable hematologic parameter [area under the curve (AUC) 0.855, 95% confidence interval (CI): 0.778-0.932]. In a multivariate analysis, symptom duration (symptoms beyond the golden time) was associated with orchiectomy in patients with testicular torsion. Conclusions: MPV showed the greatest hematologic value in the early stage of testicular torsion and epididymitis, suggesting its potential use for the differential diagnosis of these two conditions within the golden time.

Do prostate-specific antigen parameters have a similar role in predicting prostate cancer regardless of serum testosterone levels in men with gray-zone prostate-specific antigen levels?

Background: To evaluate whether various prostate-specific antigen (PSA) parameters have a similar diagnostic value in predicting prostate cancer (PCa) in men with gray-zone PSA levels (4.0-10.0 ng/mL) depending on different serum testosterone levels. Methods: We retrospectively reviewed the data of 635 men with gray-zone PSA levels who underwent prostate biopsy between January 2015 and December 2019. The study cohort was divided into two groups according to serum testosterone levels: normal (≥300 ng/dL) and low (<300 ng/dL) testosterone. Using the area under the receiver-operating characteristic curve (AUC), we analyzed the diagnostic accuracy of PSA parameters (total PSA, free PSA, free-to-total PSA ratio, testosterone-to-PSA ratio, and PSA density) in predicting PCa and compared the results between the two groups. Results: The median age was 68 (range, 40-88) years, and 76.1% (483 of 635) of the men had low testosterone levels. The PCa incidence was higher in the low testosterone group than in the normal testosterone group (45.5% vs. 35.5%, P=0.030). The AUC of free-to-total PSA ratio for predicting PCa showed no difference between the normal and low testosterone groups (AUC 0.616 vs. 0.684, P=0.257). Moreover, total PSA, testosterone-to-PSA ratio, and PSA density showed similar performance in predicting PCa between the two groups. Conclusions: The analyzed PSA parameters showed a similar diagnostic value in predicting PCa regardless of testosterone levels in men with gray-zone PSA levels.

Efficacy and Safety of Mirodenafil Oro-Dispersible Film in Korean Patients with Erectile Dysfunction: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Phase IV Study.

PURPOSE: To investigate the efficacy, safety, and tolerability of oro-dispersible film (ODF) formulation of mirodenafil 50 mg and 100 mg for the treatment of patients with erectile dysfunction (ED) in Korea. MATERIALS AND METHODS: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 129 subjects was performed. Subjects were randomized to either placebo or mirodenafil ODF 50 mg or 100 mg to be taken in an "on demand" manner for 8 weeks. The primary efficacy variable was the International Index of Erectile Dysfunction (IIEF)-5 questionnaire. The secondary efficacy variables comprised Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ), and the Life Satisfaction Checklist (LSC). RESULTS: IIEF-5 was significantly increased in all groups after treatment. However, compared to the placebo group, only the mirodenafil ODF 100 mg group showed a significant difference. SEP2 and SEP3 were increased in both mirodenafil groups; however, the increase was not statistically significant for SEP2. In terms of GAQ and LSC, the mirodenafil ODF groups showed significant increases compared with the baseline. Most treatment-associated adverse events were mild and resolved spontaneously. CONCLUSIONS: Mirodenafil ODF is an effective and well-tolerated agent for the treatment of patients with ED in Korea.

Does music from noise-canceling headphones have a beneficial effect on men undergoing transrectal ultrasound-guided prostate biopsy?

BACKGROUND: The objective of this study was to evaluate the effect of music with noise-canceling headphones on men undergoing transrectal ultrasound-guided prostate biopsy (TRUSPB) in a prospective randomized study. METHODS: From January to February 2020, 94 men underwent TRUSPB at our institution. They were divided into two groups and wore noise-cancelling headphones-group 1 (n = 47) did not listen to music and group 2 (n = 47) listened to music. We examined the patients' clinical characteristics and compared the objective and subjective measurements before and after the procedures. Primary outcomes included vital signs, the State-Trait Anxiety Inventory (STAI, 20-80) scale; and the visual analog scale (VAS, 0-10) for the assessments of pain, satisfaction, and willingness to repeat the procedure. RESULTS: There were no significant differences in patients' characteristics or the prebiopsy status between the groups. Postbiopsy vital signs for objective parameters were statistically similar between the groups; however, the subjective parameters were not. Postbiopsy STAI-state and VAS scores were significantly lower and VAS scores for the patients' satisfaction and willingness to repeat the procedure were significantly higher in Group 2 than in Group 1 (p = 0.004, p = 0.009, p = 0.004, and p = 0.003, respectively). In addition, changes in the STAI-state score before and after the procedure were significant in Group 2 (p = 0.001). CONCLUSIONS: Music from noise-canceling headphones may have beneficial effects on anxiety, pain, satisfaction, and willingness to repeat the procedure in men undergoing TRUSPB.

Is acute kidney injury after laparoscopic adrenalectomy related to the progression of chronic kidney disease in patients with primary aldosteronism?

PURPOSE: This study was conducted to investigate the predictors of kidney outcome after laparoscopic adrenalectomy in patients with primary aldosteronism (PA). MATERIALS AND METHODS: We retrospectively reviewed the medical records of 74 patients who underwent unilateral adrenalectomy for the treatment of PA from January 2011 to December 2019. Patient characteristics and serial data on postoperative changes in kidney function were analyzed and compared between the two groups according to the presence of acute kidney injury (AKI). Postoperative AKI was defined as a decline in the estimated glomerular filtration rate (eGFR) of >50% or an increase in the serum creatinine level of ≥0.3 mg/dL at 1 week after surgery compared with perioperative levels. Chronic kidney disease (CKD) was defined as an eGFR < 60 mL/min/1.73 m² present for 3 months. RESULTS: Nineteen patients (25.7%) had postoperative AKI. Patients who experienced postoperative AKI had higher aldosterone-to-renin ratios, higher rates of dyslipidemia, and more left ventricular hypertrophy than did patients without postoperative AKI (p=0.015, 0.036, and 0.033, respectively). Twenty-eight patients (37.8%) had CKD at 6 months after surgery, including 15 patients who had newly progressed to CKD postoperatively. In the multivariate regression analysis of patients without preoperative CKD, the only independent predictor of the progression to CKD was preoperative albuminuria (p=0.007). CONCLUSIONS: In this study, one-quarter of the patients had postoperative AKI after unilateral adrenalectomy for the treatment of PA. However, postoperative AKI was not directly correlated with CKD progression. Preoperative albuminuria was an independent predictor of the progression of CKD.

Changes of Apomorphine-Induced Vaginal Hemodynamics in an Ovariectomized Rat Model Using Near-Infrared Spectroscopic Probe.

INTRODUCTION: Female sexual arousal disorder (FSAD) can be caused by the change in vaginal structure due to the decline of estrogen and one of the main symptoms is vaginal dryness. FSAD is a prevalent problem afflicting women all over the world and thus the interest is growing on the matter, but related studies of monitoring FSAD using a non-invasive optical method barely have been carried out. AIM: This study aims to investigate the longitudinal changes in female sexual arousal response induced by apomorphine (APO) administration in the ovariectomized rat using near-infrared spectroscopy (NIRS) probe. METHODS: To elicit sexual arousal, APO was administered subcutaneously to animals (n = 6) before and after ovariectomy, and the changes in oxyhemoglobin (OHb), deoxyhemoglobin (RHb), total hemoglobin (THb) concentration, and temperature on the vaginal wall after APO administration were monitored bi-weekly for 8 weeks. Furthermore, estradiol hormone, vaginal secretion, and body weight have been measured for comparison with the results from vaginal hemodynamics. RESULTS: APO administration caused the increase of vaginal OHb and RHb concentration but a decrease in temperature. The amplitude of OHb, RHb, and THb increase induced by APO gradually decreased over 8 weeks after ovariectomy while the decrease in vaginal temperature became profound. The level of estradiol and vaginal secretions also decreased over 8 weeks after ovariectomy, but bodyweight showed an increasing trend. CONCLUSIONS: A comparison between the parameters measured from the NIRS probe and the others (estradiol level, amount of vaginal secretion, and body weight) proved that the NIRS has the potential as a monitoring tool to evaluate female sexual arousal response. Jeong H, Lee HS, Seong M, et al. Changes of Apomorphine-Induced Vaginal Hemodynamics in an Ovariectomized Rat Model Using Near-Infrared Spectroscopic Probe. J Sex Med 2021;18:1328-1336.

COVID Pandemic Impact on Healthcare Provision and Patient Psychosocial Distress: A Multi-National Cross-Sectional Survey among Asia-Pacific Countries.

PURPOSE: COVID pandemic significantly affected the delivery and maintenance of healthcare system, resulting in greater utilization of digital health interventions. MATERIALS AND METHODS: This multi-national cross-sectional survey was administered to clinicians working in major Asia-Pacific cities during the mandatory social lockdown period in June 2020. Clinical demographics and professional data, delivery of Andrology-related healthcare services, and patient distress based on validated questionnaires such as Depression and Anxiety Stress Scales (DASS) and Decisional Engagement Scale (DES) were collected. RESULTS: Telehealth medicine was instituted in all the centres with the majority of centres (92.9%) reported a 50% or more reduction in out-patient related services. The numbers of phone calls, emails correspondence and educational webinars have significantly increased. Despite the provision of reasons for changes in healthcare service and delay in surgery, more than half of the patients (57.1%) rated 2 on the DASS score for the item on patients over-react to situations, while a third of the patients (35.7%) scored a 2 for DASS item on patients being more demanding or unreasonable. The DES scores were more positive with most patients reported a score above 7 out of 10 in terms of items on accepting current arrangement (85.7%), confident in clinician decision-making about treatment (92.9%) and comfortable that the decision is consistent with their preferences (71.4%). Most patients (85.7%) indicated their preferences for more detailed information on healthcare provision. CONCLUSIONS: Our study showed telehealth services were integrated early and successfully during the COVID pandemic and patients were generally receptive with minimal psychosocial distress.

International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women.

BACKGROUND: The Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Global Position Statement) recommended testosterone therapy for postmenopausal women with hypoactive sexual desire disorder (HSDD). AIM: To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with HSDD. METHODS: The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women. Consensus was reached using a modified Delphi method. OUTCOMES: A clinically useful guideline following a biopsychosocial assessment and treatment approach for the safe and efficacious use of testosterone in women with HSDD was developed including measurement, indications, formulations, prescribing, dosing, monitoring, and follow-up. RESULTS: Although the Global Position Statement endorses testosterone therapy for only postmenopausal women, limited data also support the use in late reproductive age premenopausal women, consistent with the International Society for the Study of Women's Sexual Health Process of Care for the Management of HSDD. Systemic transdermal testosterone is recommended for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems. Current available research supports a moderate therapeutic benefit. Safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established. Before initiation of therapy, clinicians should provide an informed consent. Shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks. A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring. Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women. Patients should be assessed for signs of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range. Compounded products cannot be recommended because of the lack of efficacy and safety data. CLINICAL IMPLICATIONS: This clinical practice guideline provides standards for safely prescribing testosterone to women with HSDD, including identification of appropriate patients, dosing, and monitoring. STRENGTHS & LIMITATIONS: This evidence-based guideline builds on a recently published comprehensive meta-analysis and the Global Position Statement endorsed by numerous societies. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging. CONCLUSION: Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a significant unmet need. Parish SJ, Simon JA, Davis SR, et al. International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med 2021;18:849-867.

International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women.

Background: The Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Global Position Statement) recommended testosterone therapy for postmenopausal women with hypoactive sexual desire disorder (HSDD). Aim: To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with HSDD. Methods: The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women. Consensus was reached using a modified Delphi method. Outcomes: A clinically useful guideline following a biopsychosocial assessment and treatment approach for the safe and efficacious use of testosterone in women with HSDD was developed including measurement, indications, formulations, prescribing, dosing, monitoring, and follow-up. Results: Although the Global Position Statement endorses testosterone therapy for only postmenopausal women, limited data also support the use in late reproductive age premenopausal women, consistent with the International Society for the Study of Women's Sexual Health Process of Care for the Management of HSDD. Systemic transdermal testosterone is recommended for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems. Current available research supports a moderate therapeutic benefit. Safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established. Before initiation of therapy, clinicians should provide an informed consent. Shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks. A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring. Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women. Patients should be assessed for signs of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range. Compounded products cannot be recommended because of the lack of efficacy and safety data. Clinical Implications: This clinical practice guideline provides standards for safely prescribing testosterone to women with HSDD, including identification of appropriate patients, dosing, and monitoring. Strengths & Limitations: This evidence-based guideline builds on a recently published comprehensive meta-analysis and the Global Position Statement endorsed by numerous societies. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging. Conclusion: Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a significant unmet need.

International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women.

AIM: To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with hypoactive sexual desire disorder (HSDD). METHODS: The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women. Consensus was reached using a modified Delphi method. OUTCOMES: A clinically useful guideline following a biopsychosocial assessment and treatment approach for the safe and efficacious use of testosterone in women with HSDD was developed including measurement, indications, formulations, prescribing, dosing, monitoring, and follow-up. RESULTS: Although the Global Position Statement endorses testosterone therapy for only postmenopausal women, limited data also support the use in late reproductive age premenopausal women, consistent with the International Society for the Study of Women's Sexual Health Process of Care for the Management of HSDD. Systemic transdermal testosterone is recommended for women with HSDD not primarily related to modifiable factors or comorbidities such as relationship or mental health problems. Current available research supports a moderate therapeutic benefit. Safety data show no serious adverse events with physiologic testosterone use, but long-term safety has not been established. Before initiation of therapy, clinicians should provide an informed consent. Shared decision-making involves a comprehensive discussion of off-label use, as well as benefits and risks. A total testosterone level should not be used to diagnose HSDD, but as a baseline for monitoring. Government-approved transdermal male formulations can be used cautiously with dosing appropriate for women. Patients should be assessed for signs of androgen excess and total testosterone levels monitored to maintain concentrations in the physiologic premenopausal range. Compounded products cannot be recommended because of the lack of efficacy and safety data. CLINICAL IMPLICATIONS: This clinical practice guideline provides standards for safely prescribing testosterone to women with HSDD, including identification of appropriate patients, dosing, and monitoring. STRENGTHS AND LIMITATIONS: This evidence-based guideline builds on a recently published comprehensive meta-analysis and the Global Position Statement endorsed by numerous societies. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging. CONCLUSION: Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a significant unmet need.