Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI).

BACKGROUND: No validated English language patient-reported outcome (PRO) currently exists that assesses satisfaction with inflatable penile prosthesis (IPP). Satisfaction data have been largely based primarily on surgeon assessment of patients or using questionnaires that have not been designed for this purpose. AIM: To develop an English-language validated PRO that assesses patient satisfaction after IPP surgery. METHODS: Initially, a literature review and discussions with experts defined domains important to IPP satisfaction (pain, appearance, function, overall satisfaction). The initial 35-item Satisfaction Survey for Inflatable Penile Implant (SSIPI) was developed. Cognitive interviews were then performed with IPP patients (n = 12) to gain feedback on the SSIPI domains and items. These data were used to modify SSIPI with the addition of 2 questions for a final item number of 37. Patients from 4 centers, who were between 6 months and 5 years after IPP, were administered the questionnaire through RedCap. Reliability statistics and content analysis were used to winnow questions to yield the final 16-item version of the SSIPI. Internal consistency was assessed via Cronbach's alpha and item-total correlation. Test-retest reliability was assessed via intraclass correlation coefficients using baseline and 2-week data. For convergent validity, the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship (SEAR) questionnaire were used. For discriminant validity, the International Prostate Symptom Score (IPSS) was used. Confirmatory factor analysis was used to assess the factor structure of the SSIPI. OUTCOMES: Internal consistency, test-retest reliability, convergent and discriminant validity, and confirmatory factor analysis were assessed. RESULTS: 118 men were surveyed. Mean age was 66.8 ± 9.5 years. The 16-item SSIPI showed high internal consistency with an overall Cronbach's Alpha of 0.97 (domains 0.85-0.89). Item-total correlations for individual items to subscales ranged from 0.60 to 0.91. The overall test-retest reliability was 0.94 (domains 0.87-0.93). Erectile Dysfunction Inventory of Treatment Satisfaction and Self-Esteem and Relationship had correlations of 0.84 overall (domains 0.57-0.79) and 0.47 overall (domains 0.34-0.44), respectively. International Prostate Symptom Score (discriminant validity) had correlations of -0.29 overall (domains -0.17 to -0.31). CLINICAL IMPLICATIONS: SSIPI is the first English-language validated IPP satisfaction PRO. This will enable clinicians to collect satisfaction data in a standardized way. STRENGTHS AND LIMITATIONS: As strengths we have used a rigorous psychometric process and have no industry sponsorship. Limitations include small numbers of specific subpopulations. CONCLUSION: The SSIPI has demonstrated robust psychometric properties. Salter CA, Bach PV, Jenkins L, et al. Development and Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI). J Sex Med 2021;18:1641-1651.

Diagnosing Sexual Dysfunction in Men and Women: Sexual History Taking and the Role of Symptom Scales and Questionnaires.

INTRODUCTION: A detailed sexual history is the cornerstone for all sexual problem assessments and sexual dysfunction diagnoses. Diagnostic evaluation is based on an in-depth sexual history, including sexual and gender identity and orientation, sexual activity and function, current level of sexual function, overall health and comorbidities, partner relationship and interpersonal factors, and the role of cultural and personal expectations and attitudes. AIM: To propose key steps in the diagnostic evaluation of sexual dysfunctions, with special focus on the use of symptom scales and questionnaires. METHODS: Critical assessment of the current literature by the International Consultation on Sexual Medicine committee. MAIN OUTCOME MEASURES: A revised algorithm for the management of sexual dysfunctions, level of evidence, and recommendation for scales and questionnaires. RESULTS: The International Consultation on Sexual Medicine proposes an updated algorithm for diagnostic evaluation of sexual dysfunction in men and women, with specific recommendations for sexual history taking and diagnostic evaluation. Standardized scales, checklists, and validated questionnaires are additional adjuncts that should be used routinely in sexual problem evaluation. Scales developed for specific patient groups are included. Results of this evaluation are presented with recommendations for clinical and research uses. CONCLUSION: Defined principles, an algorithm and a range of scales may provide coherent and evidence based management for sexual dysfunctions.

The International Society for Sexual Medicine's Process of Care for the Assessment and Management of Testosterone Deficiency in Adult Men.

INTRODUCTION: In 2014, the International Society for Sexual Medicine (ISSM) convened a panel of experts to develop an evidence-based process of care for the diagnosis and management of testosterone deficiency (TD) in adult men. The panel considered the definition, epidemiology, etiology, physiologic effects, diagnosis, assessment and treatment of TD. It also considered the treatment of TD in special populations and commented on contemporary controversies about testosterone replacement therapy, cardiovascular risk and prostate cancer. AIM: The aim was to develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of diagnosis and management of TD for clinicians without expertise in endocrinology, such as physicians in family medicine and general urology practice. METHOD: A comprehensive literature review was performed, followed by a structured, 3-day panel meeting and 6-month panel consultation process using electronic communication. The final guideline was compiled from reports by individual panel members on areas reflecting their special expertise, and then agreed by all through an iterative process. RESULTS: This article contains the report of the ISSM TD Process of Care Committee. It offers a definition of TD and recommendations for assessment and treatment in different populations. Finally, best practice treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with TD. CONCLUSION: Development of a process of care is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to new insights into the pathophysiology of TD, as well as new, efficacious and safe treatments. We recommend that this process of care be reevaluated and updated by the ISSM in 4 years.

Clinical interviewing techniques and sexuality questionnaires for male and female cancer patients.

INTRODUCTION: Sexuality is an important aspect of quality of life; however, cancer and its treatments may impact the sexual function of men and women. Both cancer survivors and healthcare providers have barriers to addressing sexual problems in the clinical encounter. AIM: To summarize the key points from the two authors' oral presentations at the Cancer Survivorship and Sexual Health Symposium, International Society for Sexual Medicine-Sexual Medicine Society of North America (ISSM-SMSNA) Joint Meeting, Washington, DC, June 2011. METHODS: To describe patient-centered communication skills that can improve communication without excessively increasing the length of the visit. To review the validated sexuality measures that can assist clinicians in gathering sexual health information and assessing the response to therapeutic interventions for sexual problems. MAIN OUTCOME MEASURES: Sexual health interviewing skills including screening, assessment, open-ended questions, empathic delineation, and counseling are discussed. Key sexuality scales including the rationale for their use, psychometric properties, and patient-reported outcomes are summarized. RESULTS: Optimal approaches to the spectrum of communication challenges in the male and female sexual health encounter are exemplified. Advantages and limitations of the array of measures, including structured interviews, self-administered questionnaires, daily diaries, and event logs, are explained. CONCLUSIONS: Practitioners can improve their detection and management of sexual concerns in cancer survivors by employing efficient patient-centered communication skills in conjunction with validated sexuality scales.

Summary of the recommendations on sexual dysfunctions in men.

INTRODUCTION: Sexual health is an integral part of overall health. Sexual dysfunction can have a major impact on quality of life and psychosocial and emotional well-being. AIM: To provide evidence-based, expert-opinion consensus guidelines for clinical management of sexual dysfunction in men. METHODS: An international consultation collaborating with major urologic and sexual medicine societies convened in Paris, July 2009. More than 190 multidisciplinary experts from 33 countries were assembled into 25 consultation committees. Committee members established scope and objectives for each chapter. Following an exhaustive review of available data and publications, committees developed evidence-based guidelines in each area. Main Outcome Measures. New algorithms and guidelines for assessment and treatment of sexual dysfunctions were developed based on work of previous consultations and evidence from scientific literature published from 2003 to 2009. The Oxford system of evidence-based review was systematically applied. Expert opinion was based on systematic grading of medical literature, and cultural and ethical considerations. RESULTS: Algorithms, recommendations, and guidelines for sexual dysfunction in men are presented. These guidelines were developed in an evidence-based, patient-centered, multidisciplinary manner. It was felt that all sexual dysfunctions should be evaluated and managed following a uniform strategy, thus the International Consultation of Sexual Medicine (ICSM-5) developed a stepwise diagnostic and treatment algorithm for sexual dysfunction. The main goal of ICSM-5 is to unmask the underlying etiology and/or indicate appropriate treatment options according to men's and women's individual needs (patient-centered medicine) using the best available data from population-based research (evidence-based medicine). Specific evaluation, treatment guidelines, and algorithms were developed for every sexual dysfunction in men, including erectile dysfunction; disorders of libido, orgasm, and ejaculation; Peyronie's disease; and priapism. CONCLUSIONS: Sexual dysfunction in men represents a group of common medical conditions that need to be managed from a multidisciplinary perspective.

Association of sexual dysfunction with lower urinary tract symptoms of BPH and BPH medical therapies: results from the BPH Registry.

OBJECTIVES: The severity of lower urinary tract symptoms (LUTS) has correlated with erectile dysfunction (ED) and ejaculatory dysfunction (EjD) in large-scale epidemiologic studies. ED and EjD are also side effects of some medical therapies for LUTS suggestive of benign prostatic hyperplasia (LUTS/BPH). These relationships were examined in a physician office-based population of men enrolled in the BPH Registry. METHODS: Enrolled men with LUTS/BPH who completed the International Prostate Symptom Score (IPSS), IPSS bother question, 5-item International Index of Erectile Function, and the 3 ejaculatory function items of the Male Sexual Health Questionnaire-EjD short form at baseline were eligible. The relationship between sexual dysfunction and LUTS/BPH and BPH medical therapies were examined using multivariate analyses. RESULTS: Of 6924 men enrolled, 5042 (mean age 65 years) completed all 4 baseline assessments. Of 3084 sexually active men, age, total IPSS, IPSS bother score, hypertension, diabetes, and black race/ethnicity were independent predictors of both ED and EjD (all P < .05). For the subset of 1362 men receiving BPH medical therapy, a significant association (P < .0001) was demonstrated for ED and EjD with specific BPH medical therapies. The alpha(1A)-subtype nonsuperselective quinazoline alpha(1)-blockers alfuzosin, doxazosin, and terazosin appeared to be associated with better ejaculatory function than were the alpha(1A)-subtype superselective sulfonamide alpha(1)-blocker tamsulosin, 5alpha-reductase inhibitors, and alpha(1)-blocker plus 5alpha-reductase inhibitor combination therapy. CONCLUSIONS: These results have provided additional evidence of the link between LUTS/BPH and sexual dysfunction in aging men and support clinical trial results indicating different rates of sexual side effects for BPH medical therapies.

Development and validation of four-item version of Male Sexual Health Questionnaire to assess ejaculatory dysfunction.

OBJECTIVES: An abridged version of the 25-item Male Sexual Health Questionnaire (MSHQ) was developed and validated (MSHQ-EjD Short Form) for assessing ejaculatory dysfunction (EjD). METHODS: The MSHQ was administered to 1245 men in the Men's Sexual Health Population Survey, 179 gay/bisexual men in the Urban Men's Health Study, and 6909 men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in the BPH Registry & Patient Survey. Factor analysis, scale reliability, construct and discriminant validity, and the correlation between the MSHQ-EjD Short Form and the MSHQ ejaculatory function domain were assessed. RESULTS: Factor loadings of greater than 0.5 were demonstrated for four ejaculatory function items (force, volume, frequency, and delay). The force and volume of ejaculation had the greatest factor loadings (range 0.77 to 0.81), followed by frequency of ejaculation (0.64 and 0.66). These three ejaculatory function items had a high degree of internal consistency (Cronbach alpha > or = 0.78) and test-retest reliability (r = 0.72). The three items discriminated between men with none/mild LUTS and those with moderate/severe LUTS (P <0.001). After adjusting for age, depression, and erectile function, the odds ratio for a diagnosis of moderate/severe LUTS was 0.68 (95% confidence interval 0.49 to 0.96; P <0.05). The three items had a correlation coefficient of 0.95 with the 7-item MSHQ ejaculatory function domain. The MSHQ ejaculation bother item, an independent domain, showed moderate correlation with the three ejaculatory function items (r = -0.41 and r = -0.45). CONCLUSIONS: The results of our study have shown that the MSHQ-EjD Short Form, with three ejaculatory function items and one ejaculation bother item, has excellent psychometric properties and should be a useful instrument for assessing EjD in clinical and research settings.