Publications by authors named "Althof S"

This paper provides a summary of the biopsychosocial approach to the identification of female sexual dysfunction, with a particular focus on psychological, interpersonal, and sociocultural components. A summary of psychotherapeutic approaches to the management of female sexual dysfunction, for cases warranting a specialist referral, is provided. Approaches including sensate focus sex therapy, cognitive behavioral therapy, mindfulness-based approaches, and systematic desensitization are summarized.

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Background: Approximately 26% of adult women in the United States suffer from female sexual arousal disorder (FSAD), yet little has been done to compare the experience of FSAD in pre- and postmenopausal women, which is critical to enhance the current understanding of FSAD and inform the development and assessment of treatment options for these patient populations.

Aim: To explore the experience of condition-associated symptoms and the relative importance of FSAD symptoms, including their severity, bother, and impact, on participants' health-related quality of life (HRQoL) in pre- and postmenopausal women with FSAD.

Methods: In-depth, qualitative, semistructured concept elicitation interviews were conducted with premenopausal (n = 23) and postmenopausal (n = 13) women who were clinically diagnosed with FSAD by a trained sexual medicine clinician.

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Introduction: Fifteen years have passed since the International Society of Sexual Medicine first established the 3-pronged criteria for premature ejaculation (PE): a short ejaculation latency, lack of ejaculatory control, and bother/distress. Although the process of establishing valid criteria for any condition or disorder is an ongoing one, a dearth of targeted research on these criteria has hindered professional societies from updating and revising them.

Objectives: To review and critique existing criteria used in the diagnosis of PE, to identify specific problems with them, and to recommend studies that will address shortcomings.

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Purpose: Men who ejaculate before or shortly after penetration, without a sense of control, and who experience distress related to this condition may be diagnosed with premature ejaculation (PE), while men who experience difficulty achieving sexual climax may be diagnosed with delayed ejaculation (DE). The experience of many clinicians suggest that these problems are not rare and can be a source of considerable embarrassment and dissatisfaction for patients. The role of the clinician in managing PE and DE is to conduct appropriate investigation, to provide education, and to offer available treatments that are rational and based on sound scientific data.

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Background: There are several problems with diagnostic criteria for premature ejaculation (PE) that lack objectivity, clarity and precision. They hamper accurate determination of PE prevalence estimates, investigations into the etiology of the dysfunction, impact on partners, development of validated Patient Reported Outcomes, regulatory authority oversight, and which men might benefit from specific treatment interventions.

Aim: We sought to review, analyze and comment on the evolution of the definitions of PE and offer suggestions for future directions for PE definitions.

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Background: Erectile dysfunction is one of many conditions associated with depression, but few studies exist to establish the risk of major depressive disorder (MDD) in the large population of men with erectile dysfunction, and it is unclear whether erectile dysfunction (ED) treatment is associated with decreased rates of MDD.

Aim: We determined the risk of major depressive disorder in men with erectile dysfunction and evaluated whether treatment of ED with phosphodiesterase-5 inhibitor or penile prosthesis is associated with a lower risk of developing major depressive disorder.

Methods: We reviewed a large, retrospective, cohort that utilized electronic health record data collected by the TriNetX Research Network, a global federated database that provides healthcare data for analysis.

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Article Synopsis
  • There is currently no validated English-language patient-reported outcome (PRO) tool to measure satisfaction among men who receive inflatable penile prostheses (IPP), relying instead on surgeon assessments and unsuitable questionnaires.
  • The study aimed to create a validated PRO specifically designed to assess patient satisfaction post-IPP surgery by reviewing literature, consulting experts, and gathering patient feedback.
  • After refining the initial 35-item questionnaire through cognitive interviews and statistical analysis, researchers developed a final 16-item Satisfaction Survey for Inflatable Penile Implant (SSIPI), demonstrating high reliability and validity in measuring patient satisfaction levels.
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Background: The Elements of Desire Questionnaire (EDQ) is a patient-reported outcome (PRO) measure developed to evaluate sexual desire and was included in two identically designed phase 3 clinical trials (RECONNECT) as an exploratory endpoint. The EDQ was developed based on a literature review, qualitative research with patients with hypoactive sexual desire disorder (HSDD), and input from clinical experts. This instrument is intended to be used to collect efficacy data in clinical trials evaluating potential treatments for HSDD.

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Background: Clinical trials evaluating new treatments for premature ejaculation (PE) should ideally include both objective end points and patient reported outcomes (PROs), but there is no consensus currently over the optimal measures or combination of outcomes. In addition, many PROs use a 1-month recall period, despite concerns about potential recall bias.

Aims: Data from a clinical trial of men with lifelong PE were used to examine the consistency of 2 core items of the Premature Ejaculation Profile (PEP), a widely used PRO for assessing subjective aspects of PE.

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Introduction: Cligosiban is an orally administered, centrally penetrant oxytocin receptor antagonist being developed to treat premature ejaculation (PE).

Aim: To determine the efficacy of 3 dose levels of cligosiban caplets to prolong intravaginal ejaculation latency time (IELT) and improve patient-reported outcomes in men with lifelong PE.

Methods: Patients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments.

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Introduction: Cligosiban is an orally administered oxytocin receptor antagonist being developed to treat premature ejaculation (PE).

Aim: To determine the safety and efficacy of cligosiban capsules (dose range 400-800 mg) to improve intravaginal ejaculation latency time (IELT) and patient-reported outcomes in men with severe lifelong PE.

Methods: Patients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments.

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Article Synopsis
  • Responder analyses are crucial for assessing if changes in clinical trials, especially those focused on patient-reported outcomes related to female sexual health, are clinically meaningful.
  • The study aimed to determine the minimal clinically important difference (MCID) for scores on questionnaires related to female sexual functioning during a trial of the drug bremelanotide for women with hypoactive sexual desire disorder (HSDD) and related conditions.
  • Results showed significant improvements at the 1.75 mg dose across all evaluated endpoints compared to placebo, aligning with expert estimates for clinically meaningful differences.
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Sexual well-being frequently declines following the menopause transition and can be associated with significant personal and relationship distress. This distress is the hallmark of female sexual dysfunction (FSD). FSD is highly prevalent in postmenopausal women.

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Objective: To quantify reports made to the Food and Drug Administration Adverse Event Reporting System (FAERS), create a demographic of patient reports, and examine the cluster of symptoms to correlate consistency of postfinasteride syndrome (PFS) complaints. PFS is a provisional diagnosis encompassing a cluster of sexual, physical, and psychological and/or neurologic symptoms associated with 5-alpha reductase inhibitor use that emerge or continue after discontinuation of medication.

Materials And Methods: FAERS dataset of 5-alpha reductase inhibitors from April 2011 to October 2014 was obtained.

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The International Society for the Study of Women's Sexual Health process of care (POC) for management of hypoactive sexual desire disorder (HSDD) algorithm was developed to provide evidence-based guidelines for diagnosis and treatment of HSDD in women by health care professionals. Affecting 10% of adult females, HSDD is associated with negative emotional and psychological states and medical conditions including depression. The algorithm was developed using a modified Delphi method to reach consensus among the 17 international panelists representing multiple disciplines.

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Aim: To determine what constitutes a clinically important difference (CID) on the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), an 11-item validated questionnaire assessing treatment satisfaction used in clinical trials for patients with erectile dysfunction (ED).

Methods: Erectile Dysfunction Inventory of Treatment Satisfaction data were evaluated from a double-blind, fixed-dose trial of 279 men aged 18-65 years with ED who were treated with sildenafil 50 or 100 mg or placebo. The primary anchor measure was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), which has a 4-point minimal CID.

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Background: In the professional literature and among our professional societies, female sexual dysfunction nomenclature and diagnostic criterion sets have been the source of considerable controversy. Recently, a consensus group, supported by the International Society for Women's Sexual Health, published its recommendations for nosology and nomenclature, which included only one type of arousal dysfunction, female genital arousal disorder, in its classification system. Subjective arousal was considered an aspect of sexual desire and not part of the arousal phase.

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Article Synopsis
  • The Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) is developed to assess hypogonadism symptoms and track treatment responses over time.
  • A 12-week study involved 177 hypogonadal men who completed the HIS-Q and other health surveys to evaluate various symptoms and testosterone levels.
  • The HIS-Q was refined from 53 to 28 items, covering five domains of symptoms with strong reliability and validity, ensuring that it effectively measures changes in patient-reported experiences.
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