Objective and Subjective Measures of Premature Ejaculation: How Closely Do They Correspond and How Well Are the Subjective Measures Recalled?

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. The specific aim was to assess the level of agreement between the original 1-month recall version compared with a new event-based version of the scale in men meeting current definitions of lifelong PE. A further aim was to investigate the convergent validity between an objective end point of intravaginal ejaculatory latency time (IELT), subjective PEP responses, and a patient's Clinical Global Impression of Change (CGIC) measure. METHODS: For assessment of consistency of PEP responses (short-term [ie, sexual event driven] vs 1-month recall), descriptive statistics, correlation coefficients (Pearson and Spearman), and Bland-Altman plots are presented for each time interval. For assessment of convergent validity, descriptive statistics and correlation coefficients (Pearson and Spearman) are presented for each assessment with geometric mean IELT values. Results are also depicted graphically. Geometric mean IELT over the last 4 weeks of treatment and change from baseline (absolute and fold change) were estimated via a general linear model for each category of change in PEP and CGIC, adjusting for baseline IELT. OUTCOMES: PEP items administered via 1-month recall and short-term event-driven responses gave virtually identical results. There was a strong correlation (very good convergent validity) between IELT and responses to PEP and the CGIC. CLINICAL TRANSLATION: Men with lifelong PE can accurately recall their level of sexual functioning over the previous month. The PEP and CGIC are appropriate instruments to measure the subjective response of men with PE to new treatments. STRENGTHS AND LIMITATIONS: Our analyses address gaps in previously published research on PE assessment methodology. Men with acquired PE, men without partners, and men in homosexual relationships were not studied. CONCLUSIONS: In a clinical trial setting, PEP and CGIC are appropriate end points and are likely the optimal combination of PROs for use with IELT to enable a global assessment of patient response to new PE treatments. Althof S, Rosen R, Harty B, et al. Objective and Subjective Measures of Premature Ejaculation: How Closely Do They Correspond and How Well Are the Subjective Measures Recalled? J Sex Med 2020;17:634-644.

Content Validity of the Premature Ejaculation Profile, Original and Per-Event Formats, in Men with Lifelong Premature Ejaculation.

BACKGROUND: The Premature Ejaculation Profile (PEP) is a patient-reported outcome (PRO) measure that is widely used in clinical research in men with premature ejaculation (PE) but has not been fully validated for men meeting the current International Society for Sexual Medicine (ISSM) definition of lifelong PE. AIM: To explore the content validity of the PEP (original 1-month recall version and new event-driven version) in men meeting current definitions of lifelong PE and to understand the relevance of the concept of ejaculation control. METHODS: In-depth individual interviews were conducted with 24 men in a stable heterosexual relationship, including 15 with lifelong PE, 4 with acquired PE (with intravaginal ejaculation latency time values confirmed during a 4-week period of no treatment), and 5 with no sexual dysfunction. Initial concept elicitation explored individual experiences of having PE (in those with PE), experiences of control, and impact on sexual life. This was followed by a cognitive debriefing of the PEP versions. MAIN OUTCOME MEASURE: Thematic analysis was used to identify key concepts of PE, understand the experience of control in men with and without PE, and confirm understanding and relevance of questions from original and event-driven versions of the PEP. RESULTS: The interviews confirmed substantial negative consequences for men with lifelong PE. Men with and without PE could describe ejaculation control (or lack of it). The PEP was shown to cover the key concepts in PE, and the questions were easily understood in both the original or event-driven versions. The items were comprehensive, and the concept of ejaculation control was confirmed. A 1- or 2-category change in each item of the PEP was considered clinically meaningful. CLINICAL IMPLICATIONS: The PEP (original and per-event) has strong content validity for use in clinical research studies of men meeting the ISSM definition of lifelong PE. STRENGTHS & LIMITATIONS: This study addressed gaps in previously published research on the development and validation of the PEP and also confirmed that a new event-driven version is also suitable for use in research. However, the study was limited mainly to men meeting a strict definition of lifelong PE; in addition, homosexual men and those not in stable long-term relationships were not studied. CONCLUSION: Both the original and per-event PEP versions were shown to have strong content validity and be acceptable for use in men with lifelong PE. Burbridge C, Symonds T, Osterloh IH, et al. Content Validity of the Premature Ejaculation Profile, Original and Per-Event Formats, in Men with Lifelong Premature Ejaculation. J Sex Med 2019;16:569-576.

[Injection of botulinum-A toxin into bulbospongiosus muscle for primary premature ejaculation: A preliminary clinical study].

OBJECTIVE: To evaluate the efficacy and safety of injection of botulinum-A toxin into the bulbospongiosus muscle in the treatment of primary premature ejaculation (PPE). METHODS: According to the inclusion criteria, we randomly assigned 70 outpatients with PPE to a trial and a control group of equal number, the former injected with 100 U botulinum-A toxin at 10 U/ml and the latter with the same volume of saline into the bulbospongiosus muscle. Then, we obtained the intravaginal ejaculatory latency time (IELT), scores of the Premature Ejaculation Profile (PEP), Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), and Hospital Anxiety and Depression Scale (HADS), and the incidence of adverse reactions between the two groups before and 4 weeks after treatment. RESULTS: Complete data were obtained from 69 of the patients, 34 in the trial and 35 in the control group. The effectiveness rate was 47.06% (16/34) in the former but 0 in the latter. At 4 weeks after treatment, the patients of the trial group showed a significantly longer IELT than the controls and the baseline (ï¼»2.35 ± 1.83ï¼½ vs ï¼»0.79 ± 0.21ï¼½ and ï¼»0.74 ±+ 0.27ï¼½ min, P < 0.01) and the controls. The patients in the trial group, in comparison with those in the saline control group and the baseline, also exhibited significant improvement in the scores of PEP-ejaculation control (1.21 ± 1.04 vs 0.49 ± 0.56 and 0.47 ± 0.51, P < 0.05), PEP-sexual satisfaction (1.32 ± 1.01 vs 0.71 ± 0.57 and 0.79 ± 0.48, P < 0.05), PEP-PE-related distress (2.12 ± 1.01 vs 2.80 ± 0.68 and 2.76 ± 1.26, P < 0.05), and PEP-PE-induced difficult relationship with the partners (1.38 ± 0.70 vs 2.37 ± 0.55 and 2.12 ± 1.49, P < 0.05). The sexual satisfaction score of the female partners after treatment was markedly improved in the trial group as compared with the control group and the baseline (1.18 ± 1.00 vs 0.57 ± 0.50 and 0.62 ± 0.60, P < 0.05). There were no statistically significant differences in MSHQ-EjD and HADS scores between the two groups before and after treatment. Adverse reactions were observed in 6 cases (17.65%) in the trial group, including 4 cases of decreased erectile hardness (11.76%) and 2 cases of incomplete urination (5.88%), which occurred from the 3 to 4 days after injection, and those with decreased erectile hardness could complete sexual intercourse without any other treatment and recovered after 3 weeks. CONCLUSIONS: Injection of botulinum-A toxin into the bulbospongiosus muscle can be used as an option for the treatment of PPE. Its clinical application value, however, needs to be verified by further studies with larger samples.

Injection of botulinum-A toxin into bulbospongiosus muscle for primary premature ejaculation: A preliminary clinical study / 中华男科学杂志

<p><b>Objective</b>To evaluate the efficacy and safety of injection of botulinum-A toxin into the bulbospongiosus muscle in the treatment of primary premature ejaculation (PPE).</p><p><b>METHODS</b>According to the inclusion criteria, we randomly assigned 70 outpatients with PPE to a trial and a control group of equal number, the former injected with 100 U botulinum-A toxin at 10 U/ml and the latter with the same volume of saline into the bulbospongiosus muscle. Then, we obtained the intravaginal ejaculatory latency time (IELT), scores of the Premature Ejaculation Profile (PEP), Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), and Hospital Anxiety and Depression Scale (HADS), and the incidence of adverse reactions between the two groups before and 4 weeks after treatment.</p><p><b>RESULTS</b>Complete data were obtained from 69 of the patients, 34 in the trial and 35 in the control group. The effectiveness rate was 47.06% (16/34) in the former but 0 in the latter. At 4 weeks after treatment, the patients of the trial group showed a significantly longer IELT than the controls and the baseline (［2.35 ± 1.83］ vs ［0.79 ± 0.21］ and ［0.74 ±+ 0.27］ min, P < 0.01) and the controls. The patients in the trial group, in comparison with those in the saline control group and the baseline, also exhibited significant improvement in the scores of PEP-ejaculation control (1.21 ± 1.04 vs 0.49 ± 0.56 and 0.47 ± 0.51, P < 0.05), PEP-sexual satisfaction (1.32 ± 1.01 vs 0.71 ± 0.57 and 0.79 ± 0.48, P < 0.05), PEP-PE-related distress (2.12 ± 1.01 vs 2.80 ± 0.68 and 2.76 ± 1.26, P < 0.05), and PEP-PE-induced difficult relationship with the partners (1.38 ± 0.70 vs 2.37 ± 0.55 and 2.12 ± 1.49, P < 0.05). The sexual satisfaction score of the female partners after treatment was markedly improved in the trial group as compared with the control group and the baseline (1.18 ± 1.00 vs 0.57 ± 0.50 and 0.62 ± 0.60, P < 0.05). There were no statistically significant differences in MSHQ-EjD and HADS scores between the two groups before and after treatment. Adverse reactions were observed in 6 cases (17.65%) in the trial group, including 4 cases of decreased erectile hardness (11.76%) and 2 cases of incomplete urination (5.88%), which occurred from the 3 to 4 days after injection, and those with decreased erectile hardness could complete sexual intercourse without any other treatment and recovered after 3 weeks.</p><p><b>CONCLUSIONS</b>Injection of botulinum-A toxin into the bulbospongiosus muscle can be used as an option for the treatment of PPE. Its clinical application value, however, needs to be verified by further studies with larger samples.</p>

Attitudes of Sexual Medicine Specialists Toward Premature Ejaculation Diagnosis and Therapy.

INTRODUCTION: Premature ejaculation (PE) is one of the commonest sexual dysfunctions in men. Because the definition of and guidelines for the management of PE have been revised in recent years, our understanding of PE has changed. AIM: To investigate the clinical practice patterns of sexual medicine specialists regarding the diagnosis and treatment of PE. METHODS: Attendees of the 17th Annual Congress of the European Society of Sexual Medicine, held in February 2015 in Copenhagen, Denmark, were asked to participate in a survey during the congress. MAIN OUTCOME MEASURES: A 23-item, self-reported, closed-question questionnaire was distributed. Sociodemographic data, professional background, and personal practice patterns of the attendees were assessed in relation to PE. RESULTS: In total, 217 physicians (median age = 47 years, range = 22-74) completed the survey. Most responders (79.3%) considered PE an important sexual dysfunction that should be treated. Almost half the participants stated there is insufficient information about PE for patients and physicians (46.1% and 45.2%, respectively). When asked about the main goal of treating PE, two thirds responded that main goal is to improve patients' sexual function and 35.9% responded that the main goal was to improve partners' satisfaction. CONCLUSION: These findings confirmed that there are many differences among sex health experts in their understanding of PE. Educational activities are crucial in implementing the new guidelines on PE.

[Efficacy and safety of Yimusake Tablets plus dapoxetine hydrochloride in the treatment of premature ejaculation].

OBJECTIVE: To evaluate the effect and safety of Yimusake Tablets combined with dapoxetine hydrochloride and either of them used alone in the treatment of premature ejaculation (PE). METHODS: We randomly assigned 180 PE patients to oral medication of Yimusake Tablets at 1.5 g per night (group A), dapoxetine hydrochloride at 30 mg at 1－3 hours before anticipated sexual activity (group B), the Yimusake Tablets plus dapoxetine hydrochloride simultaneously (group C), all for 8 weeks. After 4 and 8 weeks of medication, we recorded and compared the changes in the intravaginal ejaculation latency time (IELT), measures of the PE profile (PEP), and adverse events among the three groups of patients. RESULTS: The treatment was accomplished and complete data obtained from 154 of the patients, 56 in group A, 52 in group B, and 46 in group C. After 4 and 8 weeks of medication, the mean IELT was dramatically prolonged in all the three groups as compared with the baseline (P<0.01), most significantly at 8 weeks in group C (ï¼»2.08±0.68ï¼½ min), followed by B (ï¼»1.76±0.52ï¼½ min) and A (ï¼»1.47±0.44ï¼½ min), with statistically significant differences among the three groups (P<0.01). The PEP measures were remarkably improved in group A at 8 weeks (P<0.05), and both in B and C at 4 and 8 weeks (P<0.05), most significantly at 8 weeks in group C (P<0.05), in which the patients scored 1.96±0.77 in perception of control over ejaculation, 2.62±0.98 in satisfaction with sexual intercourse, 3.04±0.62 in PE-related distress, and 3.57±0.80 in PE-induced difficult relationship with their partners, all markedly improved as compared with groups A and B (P<0.05). Adverse reactions were observed in 2 cases (3.6%) in group A, 6 cases (9.6%) in B, and 5 cases (10.9%) in C. No severe adverse events occurred in any of the patients during the study. CONCLUSIONS: Combined medication of Yimusake Tablets and dapoxetine hydrochloride, with its advantages of effectiveness and safety, deserves to be recommended for the treatment of PE.

Efficacy and safety of Yimusake Tablets plus dapoxetine hydrochloride in the treatment of premature ejaculation / 中华男科学杂志

<p><b>Objective</b>To evaluate the effect and safety of Yimusake Tablets combined with dapoxetine hydrochloride and either of them used alone in the treatment of premature ejaculation (PE).</p><p><b>METHODS</b>We randomly assigned 180 PE patients to oral medication of Yimusake Tablets at 1.5 g per night (group A), dapoxetine hydrochloride at 30 mg at 1－3 hours before anticipated sexual activity (group B), the Yimusake Tablets plus dapoxetine hydrochloride simultaneously (group C), all for 8 weeks. After 4 and 8 weeks of medication, we recorded and compared the changes in the intravaginal ejaculation latency time (IELT), measures of the PE profile (PEP), and adverse events among the three groups of patients.</p><p><b>RESULTS</b>The treatment was accomplished and complete data obtained from 154 of the patients, 56 in group A, 52 in group B, and 46 in group C. After 4 and 8 weeks of medication, the mean IELT was dramatically prolonged in all the three groups as compared with the baseline (P<0.01), most significantly at 8 weeks in group C (［2.08±0.68］ min), followed by B (［1.76±0.52］ min) and A (［1.47±0.44］ min), with statistically significant differences among the three groups (P<0.01). The PEP measures were remarkably improved in group A at 8 weeks (P<0.05), and both in B and C at 4 and 8 weeks (P<0.05), most significantly at 8 weeks in group C (P<0.05), in which the patients scored 1.96±0.77 in perception of control over ejaculation, 2.62±0.98 in satisfaction with sexual intercourse, 3.04±0.62 in PE-related distress, and 3.57±0.80 in PE-induced difficult relationship with their partners, all markedly improved as compared with groups A and B (P<0.05). Adverse reactions were observed in 2 cases (3.6%) in group A, 6 cases (9.6%) in B, and 5 cases (10.9%) in C. No severe adverse events occurred in any of the patients during the study.</p><p><b>CONCLUSIONS</b>Combined medication of Yimusake Tablets and dapoxetine hydrochloride, with its advantages of effectiveness and safety, deserves to be recommended for the treatment of PE.</p>