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Minocycline-rifampin-impregnated penile prosthesis surfaces retain antimicrobial activity following irrigation with 0.05% chlorhexidine gluconate and antibiotic solutions. 用 0.05% 葡萄糖酸氯己定和抗生素溶液冲洗后,米诺环素-利福平浸渍的阴茎假体表面仍能保持抗菌活性。
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae093
Brian H Im, Analyse Giordano, Sohan Shah, Samone Guillame, Rachel Evans, Noreen J Hickok, Paul H Chung

Background: 0.05% Chlorhexidine gluconate (CHG; Irrisept [IrriMax]) is a commercial wound irrigation solution approved by the Food and Drug Administration that has seen recent adoption in the field of prosthetic urology; however, no study has evaluated whether 0.05% CHG is compatible with the minocycline-rifampin-impregnated surface (InhibiZone) of the AMS 700 penile prosthesis (Boston Scientific).

Aim: To evaluate whether 0.05% CHG alters the antibiotic efficacy of the minocycline-rifampin-impregnated penile prosthesis surface.

Methods: Discs (8 mm) were taken by a punch biopsy (Sklar) from sterile penile prosthesis reservoirs whose surfaces had been impregnated with rifampin and minocycline. Discs (n = 10) were suspended in 0.05% CHG, vancomycin and gentamicin, or normal saline for 2 minutes to simulate intraoperative irrigation. Discs were then rinsed in normal saline to remove any unbound solution and incubated with methicillin-sensitive Staphylococcus aureus for 48 hours. Adherent surface bacteria were suspended by shaking in a 0.3% Tween 20 solution, serially diluted, plated onto 3M PetriFilms, and counted. Kirby-Bauer disc diffusion assays were conducted to generalize findings across various organisms.

Outcomes: Outcomes included (1) bacterial adherence to the implant surface measured as bacterial counts (in colony-forming units per milliliter) and (2) bacterial growth reduction measured as zones of inhibitions (in millimeters).

Results: Incubation of implant surfaces in 0.05% CHG did not alter recovered bacterial counts as compared with normal saline and vancomycin/gentamycin. Similarly, within a single bacterial species, 0.05% CHG and vancomycin/gentamycin did not alter zone-of-inhibition measurements in Kirby-Bauer disc diffusion studies.

Clinical translation: This study demonstrates in vitro that 0.05% CHG may be used directly on the minocycline-rifampin-impregnated surface without altering the antibiotic efficacy of the coating.

Strengths and limitations: Strengths include that this is the first study to evaluate if 0.05% CHG affected the minocycline-rifampin-impregnated surface. Limitations include the use of in vitro studies, which serve as a proxy for in vivo practices and may not be entirely accurate or translatable in a clinical setting.

Conclusion: 0.05% CHG does not alter the antimicrobial activity of the minocycline-rifampin-impregnated surface as compared with vancomycin/gentamycin and normal saline in vitro; however, its efficacy in clinical practice remains to be evaluated.

背景:0.05%葡萄糖酸氯己定(CHG;Irrisept [IrriMax])是一种经美国食品和药物管理局批准的商用伤口冲洗溶液,最近已被泌尿假体领域采用;然而,还没有研究评估了0.05% CHG是否与米诺环素-利福平浸渍表面(InhibiZone)兼容。目的:评估 0.05% CHG 是否会改变米诺环素-利福平浸渍阴茎假体表面(InhibiZone)的抗生素功效:从表面浸渍了利福平和米诺环素的无菌阴茎假体储存器中用打孔器活检(Sklar)取出圆片(8 毫米)。圆片(n = 10)在 0.05% CHG、万古霉素和庆大霉素或生理盐水中悬浮 2 分钟,以模拟术中灌洗。然后用生理盐水冲洗盘片以去除未结合的溶液,并与对甲氧西林敏感的金黄色葡萄球菌一起培养 48 小时。在 0.3% 的吐温 20 溶液中振荡悬浮表面附着的细菌,将其连续稀释,然后培养到 3M PetriFilms 上并计数。进行 Kirby-Bauer 盘扩散试验,以归纳各种生物的研究结果:结果包括:(1) 以细菌计数(每毫升菌落形成单位)衡量的种植体表面细菌附着情况;(2) 以抑制区(毫米)衡量的细菌生长减少情况:结果:与生理盐水和万古霉素/庆大霉素相比,用 0.05% CHG 培养种植体表面并不会改变回收的细菌数量。同样,在单一细菌种类中,0.05% CHG 和万古霉素/庆大霉素不会改变柯比-鲍尔盘扩散研究中的抑制区测量值:本研究在体外证明,0.05% CHG 可直接用于米诺环素-利福平浸渍表面,而不会改变涂层的抗生素功效:优点包括:这是首次评估 0.05% CHG 是否会影响米诺环素-利福平浸渍表面的研究。结论:与万古霉素/庆大霉素和生理盐水相比,0.05% CHG 在体外不会改变米诺环素-利福平浸渍表面的抗菌活性;但其在临床实践中的疗效仍有待评估。
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引用次数: 0
Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder. 3.6% 西地那非外用乳膏治疗女性性唤起障碍的随机安慰剂对照试验的安全性。
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae089
Andrea R Thurman, Isabella Johnson, Katherine A Cornell, Jessica Hatheway, Noel N Kim, Sharon J Parish, Clint Dart, David R Friend, Andrew Goldstein

Background: There are currently no Food and Drug Administration-approved treatments for female sexual arousal disorder (FSAD), which is physiologically analogous to male erectile dysfunction.

Aims: The study sought to test the systemic and local genital safety of topical sildenafil cream, 3.6% (sildenafil cream) among healthy premenopausal women with FSAD and their sexual partners over a 12-week treatment period.

Methods: This was a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream among healthy premenopausal women with FSAD. Safety was assessed by the frequency and incidence of treatment-emergent adverse events (TEAEs) among participants and their sexual partners. Participants recorded the incidence of TEAEs in a daily eDiary (electronic diary). Sexual partners were contacted within 72 hours of each sexual event in which investigational product was used. All participants used placebo cream for 1 month, during a single-blind run-in period, and then if eligible, were randomized 1:1 to sildenafil cream or placebo cream. Participants used their assigned investigational product over a 12-week double-blind dosing period. They attended monthly follow-up visits, in which their eDiary TEAE data were reviewed by the study staff and graded for severity and relationship to study product.

Outcomes: The frequency and incidence of TEAEs among participants and their sexual partners.

Results: During the 12-week double-blind dosing period, there were 78 TEAEs reported by 29 of 99 sildenafil-assigned participants and 65 TEAEs reported by 28 of 94 placebo-assigned participants (P = .76). All TEAEs were mild or moderate in severity. The most common treatment-related TEAE among active and placebo-assigned participants was application site discomfort. There were no differences in the number of treatment-related TEAEs among sildenafil cream vs placebo cream users (P > .99). Four sildenafil cream participants and 3 placebo cream participants discontinued the study due to TEAEs involving application site discomfort (P > .99). There were 9 TEAEs reported by 7 of 91 sexual partners exposed to sildenafil cream vs 4 TEAEs reported by 4 of 84 sexual partners exposed to placebo cream (P = .54).

Clinical implications: These data support further clinical development of topical sildenafil cream for the treatment of FSAD.

Strengths and limitations: Safety was assessed among participants and their sexual partners after 1357 and 1160 sexual experiences in which sildenafil cream or placebo cream were used, respectively. The phase 2b study was powered for the primary objectives of efficacy, rather than safety.

Conclusion: These data demonstrate that topically applied sildenafil cream was safe and well tolerated by exposed users and their sexual partners.

背景:目的:该研究旨在测试外用3.6%西地那非乳膏(西地那非乳膏)对患有FSAD的绝经前健康女性及其性伴侣在12周治疗期内的全身和局部生殖器安全性:这是一项针对患有FSAD的绝经前健康女性的2b期探索性、随机、安慰剂对照、双盲西地那非乳膏研究。安全性通过参与者及其性伴侣发生治疗突发不良事件(TEAE)的频率和发生率进行评估。参与者在每日电子日记(eDiary)中记录 TEAE 的发生率。在每次使用研究产品的性行为发生后 72 小时内与性伴侣取得联系。所有参与者在单盲磨合期内使用安慰剂药膏 1 个月,然后在符合条件的情况下按 1:1 随机分配使用西地那非药膏或安慰剂药膏。参与者在为期 12 周的双盲给药期间使用指定的研究产品。他们每月接受一次随访,由研究人员审查他们的电子日记 TEAE 数据,并根据严重程度和与研究产品的关系进行分级:结果:参与者及其性伴侣发生 TEAE 的频率和发生率:在为期 12 周的双盲给药期间,99 位西地那非配药参与者中有 29 位报告了 78 例 TEAE,94 位安慰剂配药参与者中有 28 位报告了 65 例 TEAE(P = .76)。所有 TEAE 的严重程度均为轻度或中度。活性药物和安慰剂配伍参与者中最常见的治疗相关 TEAE 是用药部位不适。西地那非乳膏与安慰剂乳膏使用者的治疗相关 TEAE 数量没有差异(P > .99)。4 名西地那非乳膏使用者和 3 名安慰剂乳膏使用者因出现涂抹部位不适的 TEAE 而中止了研究(P > .99)。91名使用西地那非乳膏的性伴侣中有7人报告了9例TEAE,而84名使用安慰剂乳膏的性伴侣中有4人报告了4例TEAE(P = .54):这些数据支持进一步开发治疗FSAD的局部西地那非乳膏:在分别使用了西地那非乳膏或安慰剂乳膏的 1357 次和 1160 次性经历后,对参与者及其性伴侣进行了安全性评估。该 2b 期研究的主要目标是疗效而非安全性:这些数据表明,局部使用西地那非乳膏是安全的,暴露使用者及其性伴侣的耐受性良好。
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引用次数: 0
Individually customized gender affirming genital procedures: techniques and considerations. 个性化定制的性别确认生殖器手术:技术和注意事项。
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae075
Mona Ascha, Siri Rigsby, Maia Shoham, Arya Andre Akhavan, Marco Swanson, Carl G Streed, Anandev Gurjala, Shane D Morrison, John Henry Pang, Thomas Satterwhite

Purpose: Gender-affirming surgery is being increasingly performed for transgender and gender-diverse individuals diagnosed with gender dysphoria. However, there is a group of patients who may seek outcomes that are either a combination of or altogether different from those of binary procedures such as penile inversion vaginoplasty or phalloplasty.

Methods: We describe surgical techniques for less commonly performed gender-affirming genital procedures, in order to introduce these procedures to the medical and surgical community.

Results: Operative techniques for phallus-preserving vaginoplasty, vagina-preserving phalloplasty, and removal of genitalia with creation of perineal urethrostomy are described. Demographic characteristics and complications of these procedures in 16 patients are reported.

Conclusion: Individually customized gender-affirming genital procedures, such as phallus-preserving vaginoplasty, vaginal-preserving phalloplasty, and removal of genitalia and creation of perineal urethrostomy, may better affirm the identities of some gender-diverse patients, and may also preserve desired sexual function of natal genitalia.

目的:越来越多的变性人和性别多元化人士被诊断出患有性别焦虑症,他们需要接受性别确认手术。然而,有一部分患者可能会寻求与阴茎倒置阴道成形术或阴茎成形术等二元手术相结合或完全不同的结果:方法:我们描述了较少实施的性别确认生殖器手术的手术技巧,以便向医学界和外科界介绍这些手术:结果:描述了保留阴茎的阴道成形术、保留阴道的阴茎成形术以及切除生殖器并进行会阴尿道造口术的手术技巧。报告了 16 名患者的人口统计学特征和这些手术的并发症:结论:个性化定制的性别确认生殖器手术,如保留阴茎的阴道成形术、保留阴道的阴茎成形术、切除生殖器并进行会阴尿道造口术,可以更好地确认一些性别多样化患者的身份,还可以保留产前生殖器的理想性功能。
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引用次数: 0
Psychiatric morbidity across the life course and provoked vulvodynia: is it dependent upon the presence of non-stress-related immune dysfunction? 整个生命过程中的精神病发病率和诱发性外阴炎:是否取决于是否存在非应激相关的免疫功能障碍?
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae082
Bernard L Harlow, Hanna Mühlrad, Jane Yan, Evelina Linnros, Donghao Lu, Matthew P Fox, Nina Bohm-Starke

Background: Vulvodynia impacts up to 8% of women by age 40, and these women may have a more compromised immune system than women with no vulvar pain history.

Aim: Given that psychiatric morbidity is associated with vulvodynia and is known to activate immune inflammatory pathways in the brain and systemically, we sought to determine whether the association between psychiatric morbidity and vulvar pain was independent of or dependent upon the presence of immune-related conditions.

Methods: Women born in Sweden between 1973 and 1996 with localized provoked vulvodynia (N76.3) and/or vaginismus (N94.2 or F52.5) diagnosed between 2001 and 2018 were matched to two women from the same birth year with no vulvar pain. International Statistical Classification of Diseases and Related Health Problems (ICD-9 or -10 codes) were used to identify women with a history of depression, anxiety, attempted suicide, neurotic disorders, stress-related disorders, behavioral syndromes, personality disorders, psychotic disorders, or chemical dependencies, as well as a spectrum of immune-related conditions. The Swedish National Prescribed Drug Register was used to identify women with filled prescriptions of antidepressants or anxiolytics.

Outcomes: Vulvodynia, vaginismus, or both were outcomes assessed in relation to psychiatric morbidity.

Results: Women with vulvodynia, vaginismus, or both, relative to those without vulvar pain, had adjusted odds ratios between 1.4 and 2.3, with CIs highly compatible with harmful effects. When we assessed women with and those without a lifetime history of immune-related conditions separately, we also observed elevated odds ratios in both groups for mood, anxiety, and neurotic and stress disorders.

Clinical implications: Documenting psychiatric impairment as a cause or consequence of vulvodynia is critical in clinical practice because psychiatric conditions may impact treatment efficacy.

Strengths and limitations: Strengths of this study include a data source that represents the entire population of women in Sweden that is known to be highly accurate because Sweden provides universal healthcare. Limitations include difficulty in making an accurate assessment of temporality between psychiatric morbidity and the first onset of vulvar pain. In addition, because Swedish registry data have limited information on lifestyle, behavioral, and anthropomorphic factors such as smoking, diet, physical activity, and obesity, these conditions could not be assessed as confounders of psychiatric morbidity and vulvar pain.

Conclusions: Immune pathways by which women with psychiatric conditions increase their risk of vulvar pain could be independent from other immune pathways.

背景:目的:鉴于精神疾病与外阴炎相关,且已知精神疾病会激活大脑和全身的免疫炎症通路,我们试图确定精神疾病发病率与外阴疼痛之间的关联是否独立于或依赖于免疫相关疾病的存在:将 1973 年至 1996 年期间在瑞典出生、2001 年至 2018 年期间确诊患有局部诱发性外阴炎(N76.3)和/或阴道炎(N94.2 或 F52.5)的女性与同年出生且无外阴疼痛的两名女性进行配对。国际疾病和相关健康问题统计分类(ICD-9 或 -10 代码)用于识别有抑郁症、焦虑症、自杀未遂、神经症、压力相关障碍、行为综合征、人格障碍、精神障碍或化学依赖症病史的女性,以及一系列免疫相关疾病。瑞典国家处方药登记册用于识别已开具抗抑郁药或抗焦虑药处方的妇女:结果:评估了外阴炎、阴道炎或两者与精神疾病发病率的关系:患有外阴炎、阴道炎或同时患有这两种疾病的女性与无外阴疼痛的女性相比,调整后的几率比为 1.4 至 2.3,CI 与有害影响高度吻合。当我们分别评估有和没有免疫相关病史的妇女时,我们还观察到两组妇女在情绪、焦虑、神经质和应激障碍方面的几率都有所上升:临床意义:记录精神损伤作为外阴炎的原因或后果在临床实践中至关重要,因为精神疾病可能会影响治疗效果:这项研究的优点包括数据来源代表了瑞典的全部女性人口,由于瑞典提供全民医疗保健服务,因此数据准确性很高。局限性包括难以准确评估精神病发病率与首次外阴疼痛之间的时间性。此外,由于瑞典登记数据中有关生活方式、行为和人体因素(如吸烟、饮食、体力活动和肥胖)的信息有限,因此无法将这些情况作为精神病发病率和外阴疼痛的混杂因素进行评估:结论:患有精神疾病的妇女增加外阴疼痛风险的免疫途径可能独立于其他免疫途径。
{"title":"Psychiatric morbidity across the life course and provoked vulvodynia: is it dependent upon the presence of non-stress-related immune dysfunction?","authors":"Bernard L Harlow, Hanna Mühlrad, Jane Yan, Evelina Linnros, Donghao Lu, Matthew P Fox, Nina Bohm-Starke","doi":"10.1093/jsxmed/qdae082","DOIUrl":"10.1093/jsxmed/qdae082","url":null,"abstract":"<p><strong>Background: </strong>Vulvodynia impacts up to 8% of women by age 40, and these women may have a more compromised immune system than women with no vulvar pain history.</p><p><strong>Aim: </strong>Given that psychiatric morbidity is associated with vulvodynia and is known to activate immune inflammatory pathways in the brain and systemically, we sought to determine whether the association between psychiatric morbidity and vulvar pain was independent of or dependent upon the presence of immune-related conditions.</p><p><strong>Methods: </strong>Women born in Sweden between 1973 and 1996 with localized provoked vulvodynia (N76.3) and/or vaginismus (N94.2 or F52.5) diagnosed between 2001 and 2018 were matched to two women from the same birth year with no vulvar pain. International Statistical Classification of Diseases and Related Health Problems (ICD-9 or -10 codes) were used to identify women with a history of depression, anxiety, attempted suicide, neurotic disorders, stress-related disorders, behavioral syndromes, personality disorders, psychotic disorders, or chemical dependencies, as well as a spectrum of immune-related conditions. The Swedish National Prescribed Drug Register was used to identify women with filled prescriptions of antidepressants or anxiolytics.</p><p><strong>Outcomes: </strong>Vulvodynia, vaginismus, or both were outcomes assessed in relation to psychiatric morbidity.</p><p><strong>Results: </strong>Women with vulvodynia, vaginismus, or both, relative to those without vulvar pain, had adjusted odds ratios between 1.4 and 2.3, with CIs highly compatible with harmful effects. When we assessed women with and those without a lifetime history of immune-related conditions separately, we also observed elevated odds ratios in both groups for mood, anxiety, and neurotic and stress disorders.</p><p><strong>Clinical implications: </strong>Documenting psychiatric impairment as a cause or consequence of vulvodynia is critical in clinical practice because psychiatric conditions may impact treatment efficacy.</p><p><strong>Strengths and limitations: </strong>Strengths of this study include a data source that represents the entire population of women in Sweden that is known to be highly accurate because Sweden provides universal healthcare. Limitations include difficulty in making an accurate assessment of temporality between psychiatric morbidity and the first onset of vulvar pain. In addition, because Swedish registry data have limited information on lifestyle, behavioral, and anthropomorphic factors such as smoking, diet, physical activity, and obesity, these conditions could not be assessed as confounders of psychiatric morbidity and vulvar pain.</p><p><strong>Conclusions: </strong>Immune pathways by which women with psychiatric conditions increase their risk of vulvar pain could be independent from other immune pathways.</p>","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11372066/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141735600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Antibiotic dip and irrigation solutions confer increased antimicrobial efficacy of inflatable penile prosthesis hydrophilic surfaces compared with 0.05% chlorhexidine gluconate. 与 0.05% 葡萄糖酸氯己定相比,抗生素浸泡液和冲洗液能提高充气式阴茎假体亲水性表面的抗菌效果。
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae073
Rishabh Simhal, Brian H Im, Sohan Shah, Samone Guillame, Carlos Perez Kerkvliet, Rachel Evans, Noreen J Hickok, Paul H Chung

Background: Chlorhexidine gluconate (CHG) (0.05%) has recently been suggested as both a dip for the hydrophilic surface and an irrigation solution in the setting of penile prosthesis (PP) surgery.

Aim: The study sought to compare the antimicrobial efficacy of 0.05% CHG with vancomycin and gentamicin (VG) antibiotics as dip and/or irrigation solutions in the setting of a hydrophilic PP surface in vitro.

Methods: Sterile PPs with a hydrophilic coating were obtained. A series of experiments were performed to evaluate the efficacy of normal saline (NS), 0.05% CHG, or VG as dip and/or irrigation solutions to reduce methicillin-sensitive Staphylococcus aureus adhesion to PP surfaces. The 8-mm discs from PPs were incubated in 105 colony-forming units/mL of methicillin-sensitive S aureus for 48 hours, plated, and counted. Disc-diffusion tests were conducted by suspending 6-mm discs for 2 minutes in NS, 0.05% CHG, or VG, then placing them coated side down onto plates streaked with the following organisms: methicillin-sensitive S aureus, S epidermidis, Enterococcus, and Escherichia coli. After 24 hours of growth, zones of inhibition were measured.

Outcomes: We found average bacterial counts (colony-forming units/mL) and zones of inhibition (mm) following a series of treatment protocols of PP discs.

Results: PP discs dipped in VG reduced bacterial adhesion to the implant surface >0.05% CHG (~5.5 log vs ~1.5 log; P < .01). Discs irrigated with either 0.05% CHG or NS removed all dip solution adsorbed to the hydrophilic surface, allowing bacterial growth. VG irrigation adsorbed to the hydrophilic surface even after 0.05% CHG or NS dips, reducing bacterial adherence (~3 log). Dipping and irrigating discs with VG was most effective in reducing adherent bacteria (~5.5 log) and was the only irrigation that showed antimicrobial activity.

Clinical translation: VG, when used both as a prophylactic dip and as an intraoperative irrigation solution for hydrophilic penile implant surfaces, has improved efficacy to 0.05% CHG and NS.

Strengths and limitations: This is the first study to compare the use of VG, 0.05% CHG, and NS as prophylactic dips and intraoperative irrigations for hydrophilic penile implant surfaces. Limitations include the use of in vitro studies, which serve as a proxy for in vivo practices and may not be entirely accurate nor translatable clinically.

Conclusion: We demonstrated the superior efficacy of VG as a combined dip and irrigation solution for hydrophilic penile implant surfaces compared with 0.05% CHG.

背景:目的:本研究旨在比较 0.05% CHG 与万古霉素和庆大霉素 (VG) 抗生素作为亲水性 PP 表面浸泡液和/或冲洗液在体外的抗菌效果:方法:获得了具有亲水涂层的无菌聚丙烯。进行了一系列实验,以评估用生理盐水(NS)、0.05% CHG 或 VG 作为浸泡液和/或灌洗液来减少对甲氧西林敏感的金黄色葡萄球菌粘附到 PP 表面的效果。将聚丙烯上的 8 毫米圆片在 105 菌落总数单位/毫升的甲氧西林敏感金黄色葡萄球菌中培养 48 小时,然后接种并计数。将 6 毫米圆片在 NS、0.05% CHG 或 VG 中悬浮 2 分钟,然后将涂有涂层的一面朝下放置在铺有以下菌种的平板上,进行圆片扩散试验:甲氧西林敏感金黄色葡萄球菌、表皮葡萄球菌、肠球菌和大肠杆菌。生长 24 小时后,测量抑菌区:我们发现了 PP 盘经过一系列处理方案后的平均细菌计数(菌落形成单位/毫升)和抑菌区(毫米):结果:蘸有 VG 的 PP 盘减少了细菌对种植体表面大于 0.05% CHG 的粘附(~5.5 log vs ~1.5 log;P 临床翻译):VG 既可作为预防性浸泡液,也可作为亲水性阴茎假体表面的术中冲洗液,其疗效优于 0.05% CHG 和 NS:这是第一项比较 VG、0.05% CHG 和 NS 作为亲水性阴茎假体表面预防性浸泡液和术中冲洗液的研究。局限性包括使用体外研究作为体内实践的替代物,可能不完全准确,也不能应用于临床:我们证明了与 0.05% CHG 相比,VG 作为阴茎亲水性植入物表面的浸泡和冲洗联合溶液具有更优越的疗效。
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引用次数: 0
Heparin-binding epidermal growth factor-like growth factor improves erectile function in streptozotocin-induced diabetic mice. 肝素结合表皮生长因子样生长因子可改善链脲佐菌素诱导的糖尿病小鼠的勃起功能。
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae079
Fitri Rahma Fridayana, Jiyeon Ock, Fang-Yuan Liu, Lashkari Niloofar, Minh Nhat Vo, Yan Huang, Guo Nan Yin, Ji-Kan Ryu
<p><strong>Background: </strong>Heparin-binding epidermal growth factor-like growth factor (HB-EGF) serves as a pro-angiogenic factor; however, there is to our knowledge currently no reported research on the relationship between HB-EGF and diabetic erectile dysfunction (ED).</p><p><strong>Aim: </strong>In this study we aimed to determine whether HB-EGF can improve the erectile function of streptozotocin-induced diabetic mice and to explore the related mechanisms.</p><p><strong>Methods: </strong>Eight-week-old male C57BL/6 mice were used for diabetes induction. Diabetes mellitus (DM) was induced by low-dose injections of streptozotocin (50 mg/kg) for 5 consecutive days. Eight weeks after streptozotocin injections, DM was determined by measuring blood glucose and body weight. Diabetic mice were treated with two intracavernous administrations of phosphate-buffered saline (20 μL) or various doses of HB-EGF (days -3 and 0; 1, 5, and 10 μg in 20 μL of phosphate-buffered saline). The angiogenesis effect of HB-EGF was confirmed by tube formation and migration assays in mouse cavernous endothelial cells and mouse cavernous pericytes under high-glucose conditions. Erectile function was measured by electrical stimulation of the cavernous nerve, as well as histological examination and Western blot analysis for mechanism assessment.</p><p><strong>Outcomes: </strong>In vitro angiogenesis, cell proliferation, in vivo intracavernous pressure, neurovascular regeneration, cavernous permeability, and survival signaling were the outcomes measured.</p><p><strong>Results: </strong>Expression of HB-EGF was reduced under diabetic conditions. Exogenous HB-EGF induced angiogenesis in mouse cavernous endothelial cells and mouse cavernous pericytes under high-glucose conditions. Erectile function was decreased in the DM group, whereas administration of HB-EGF resulted in a significant improvement of erectile function (91% of the age-matched control group) in association with increased neurovascular content, including cavernous endothelial cells, pericytes, and neuronal cells. Histological and Western blot analyses revealed a significant increase in the permeability of the corpus cavernosum in DM mice, which was attenuated by HB-EGF treatment. The protein expression of phospho-Akt Ser473 and phosphorylated endothelial nitric oxide synthase Ser1177 increased after HB-EGF treatment.</p><p><strong>Clinical implications: </strong>The use of HB-EGF may be an effective strategy to treat ED associated with DM or other neurovascular diseases.</p><p><strong>Strengths and limitations: </strong>Similarly to other pro-angiogenic factors, HB-EGF has dual roles in vascular and neuronal development. Our study focused on broadly evaluating the role of HB-EGF in diabetic ED. In view of the properties of HB-EGF as an angiogenic factor, its dose concentration should be strictly controlled to avoid potential side effects.</p><p><strong>Conclusion: </strong>In the diabetic ED mouse model in this
背景:目的:本研究旨在确定HB-EGF是否能改善链脲佐菌素诱导的糖尿病小鼠的勃起功能,并探讨相关机制:方法:用8周龄雄性C57BL/6小鼠诱导糖尿病。连续5天低剂量注射链脲佐菌素(50 mg/kg)诱导糖尿病(DM)。注射链脲佐菌素八周后,通过测量血糖和体重来确定糖尿病。糖尿病小鼠接受两次海绵体内注射磷酸盐缓冲盐水(20 μL)或不同剂量的 HB-EGF(第 3 天和第 0 天;1、5 和 10 μg 加入 20 μL 磷酸盐缓冲盐水中)治疗。小鼠海绵体内皮细胞和海绵体周细胞在高葡萄糖条件下的管形成和迁移试验证实了 HB-EGF 的血管生成作用。通过电刺激海绵体神经测量勃起功能,并通过组织学检查和 Western 印迹分析进行机制评估:结果:对体外血管生成、细胞增殖、体内海绵体内压、神经血管再生、海绵体通透性和存活信号转导进行了测量:结果:在糖尿病条件下,HB-EGF的表达量减少。在高血糖条件下,外源性HB-EGF诱导小鼠海绵体内皮细胞和海绵体周细胞的血管生成。糖尿病组的勃起功能下降,而服用 HB-EGF 后,勃起功能明显改善(为年龄匹配对照组的 91%),同时神经血管含量增加,包括海绵体内皮细胞、周细胞和神经细胞。组织学和 Western 印迹分析显示,DM 小鼠海绵体的通透性显著增加,而 HB-EGF 治疗可减轻这种情况。HB-EGF 治疗后,磷酸化-Akt Ser473 和磷酸化内皮一氧化氮合酶 Ser1177 的蛋白表达增加:临床意义:使用HB-EGF可能是治疗与DM或其他神经血管疾病相关的ED的有效策略:与其他促血管生成因子类似,HB-EGF在血管和神经元发育中具有双重作用。我们的研究侧重于广泛评估 HB-EGF 在糖尿病 ED 中的作用。鉴于 HB-EGF 作为血管生成因子的特性,应严格控制其剂量浓度,以避免潜在的副作用:结论:本研究中的糖尿病 ED 小鼠模型的勃起功能通过 HB-EGF 得到了改善,这可能会为对磷酸二酯酶 5 抑制剂无效的 ED 患者提供新的治疗策略。
{"title":"Heparin-binding epidermal growth factor-like growth factor improves erectile function in streptozotocin-induced diabetic mice.","authors":"Fitri Rahma Fridayana, Jiyeon Ock, Fang-Yuan Liu, Lashkari Niloofar, Minh Nhat Vo, Yan Huang, Guo Nan Yin, Ji-Kan Ryu","doi":"10.1093/jsxmed/qdae079","DOIUrl":"10.1093/jsxmed/qdae079","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Heparin-binding epidermal growth factor-like growth factor (HB-EGF) serves as a pro-angiogenic factor; however, there is to our knowledge currently no reported research on the relationship between HB-EGF and diabetic erectile dysfunction (ED).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Aim: &lt;/strong&gt;In this study we aimed to determine whether HB-EGF can improve the erectile function of streptozotocin-induced diabetic mice and to explore the related mechanisms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Eight-week-old male C57BL/6 mice were used for diabetes induction. Diabetes mellitus (DM) was induced by low-dose injections of streptozotocin (50 mg/kg) for 5 consecutive days. Eight weeks after streptozotocin injections, DM was determined by measuring blood glucose and body weight. Diabetic mice were treated with two intracavernous administrations of phosphate-buffered saline (20 μL) or various doses of HB-EGF (days -3 and 0; 1, 5, and 10 μg in 20 μL of phosphate-buffered saline). The angiogenesis effect of HB-EGF was confirmed by tube formation and migration assays in mouse cavernous endothelial cells and mouse cavernous pericytes under high-glucose conditions. Erectile function was measured by electrical stimulation of the cavernous nerve, as well as histological examination and Western blot analysis for mechanism assessment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Outcomes: &lt;/strong&gt;In vitro angiogenesis, cell proliferation, in vivo intracavernous pressure, neurovascular regeneration, cavernous permeability, and survival signaling were the outcomes measured.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Expression of HB-EGF was reduced under diabetic conditions. Exogenous HB-EGF induced angiogenesis in mouse cavernous endothelial cells and mouse cavernous pericytes under high-glucose conditions. Erectile function was decreased in the DM group, whereas administration of HB-EGF resulted in a significant improvement of erectile function (91% of the age-matched control group) in association with increased neurovascular content, including cavernous endothelial cells, pericytes, and neuronal cells. Histological and Western blot analyses revealed a significant increase in the permeability of the corpus cavernosum in DM mice, which was attenuated by HB-EGF treatment. The protein expression of phospho-Akt Ser473 and phosphorylated endothelial nitric oxide synthase Ser1177 increased after HB-EGF treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinical implications: &lt;/strong&gt;The use of HB-EGF may be an effective strategy to treat ED associated with DM or other neurovascular diseases.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Strengths and limitations: &lt;/strong&gt;Similarly to other pro-angiogenic factors, HB-EGF has dual roles in vascular and neuronal development. Our study focused on broadly evaluating the role of HB-EGF in diabetic ED. In view of the properties of HB-EGF as an angiogenic factor, its dose concentration should be strictly controlled to avoid potential side effects.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;In the diabetic ED mouse model in this","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141735599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Factors associated with dating app use for sexual "hookups" in the United States: insights from the National Survey of Family Growth. 美国使用约会软件进行性 "勾搭 "的相关因素:全国家庭成长调查的启示。
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae083
Albert Ha, Michael Scott, Chiyuan Amy Zhang, Frank Glover, Satvir Basran, Francesco Del Giudice, Michael L Eisenberg
<p><strong>Background: </strong>The use of dating applications for matchmaking and sexual exploits ("hookups") has increased, and this modern phenomenon has supplanted traditional socialization and relationship formation. To date, sociodemographic data on the use of dating apps has been limited.</p><p><strong>Aim: </strong>In this study, we sought to identify predictors associated with the use of dating apps in the United States.</p><p><strong>Methods: </strong>Using cross-sectional data from the 2017-2019 National Survey of Family Growth, we examined sociodemographic determinants influencing the use of dating apps to find partners for sexual intercourse. We constructed survey-weighted regression models to study these associations, with additional sensitivity analyses performed within specific subgroups. Furthermore, this study investigated the correlation of app use with sexual frequency.</p><p><strong>Outcome: </strong>Study outcomes were participant data regarding reported use of dating apps for sexual intercourse in the 2017-2019 National Survey of Family Growth.</p><p><strong>Results: </strong>A total of 11,225 respondents were examined, representing a survey-weighted total of approximately 143,201, 286 Americans. Among them, 757 respondents (6.7%), equating to approximately 8, 818, 743 individuals, reported dating app use for sexual hookups. Regression analysis revealed that factors such as male sex, White race, previous sexual experience, substance/alcohol use, history of sexually transmitted infections, same-sex attraction, and bisexuality increased the likelihood of dating app usage. Conversely, reduced odds of dating app use were observed among Catholics, Protestants, married/widowed individuals, and older respondents. Stratified analyses across various demographics, including male and female individuals aged 20 to 40 years, heterosexual, and lesbian, gay, and bisexual respondents, generally supported these trends. Notably, dating app use did not correlate with increased sexual frequency (adjusted incidence rate ratio: 1.10; 95% CI: 0.96-1.26; P = .16).</p><p><strong>Clinical implications: </strong>Dating app use is prevalent among male patients and White individuals and correlates with increased sexually transmitted infection risk, alcohol/illicit substance use, past sexual experience, and popularity within the lesbian, gay, and bisexual community, all important considerations for public health interventions. Dating app use, however, was not associated with increased sexual encounters.</p><p><strong>Strengths and limitations: </strong>Strengths of our study were the utilization of a national survey of individuals of reproductive age in the United States and focus on a clearly defined outcome of dating app utilization for the purposes of sexual intercourse. Limitations include self-reported survey responses and insufficient detail on the types and duration of dating app platforms and their use.</p><p><strong>Conclusions: </strong>Many s
背景越来越多的人使用约会应用程序来牵线搭桥和进行性剥削("勾搭"),这种现代现象已经取代了传统的社交和关系建立。迄今为止,有关约会应用程序使用情况的社会人口学数据十分有限。目的:在本研究中,我们试图找出与美国约会应用程序使用情况相关的预测因素:利用 2017-2019 年全国家庭成长调查的横截面数据,我们研究了影响使用约会应用程序寻找性伴侣的社会人口学决定因素。我们构建了调查加权回归模型来研究这些关联,并在特定亚群中进行了额外的敏感性分析。此外,本研究还调查了应用程序的使用与性生活频率的相关性:研究结果是 2017-2019 年全国家庭成长调查中有关报告使用约会应用程序进行性交的参与者数据:共调查了 11225 名受访者,代表了约 143201 286 名美国人的调查加权总数。其中,757 名受访者(6.7%)报告使用约会应用程序进行性勾搭,相当于约 8,818,743 人。回归分析表明,男性性别、白人种族、以往性经验、药物/酒精使用、性传播感染史、同性吸引和双性恋等因素增加了使用约会应用程序的可能性。相反,天主教徒、新教徒、已婚/丧偶者和年龄较大的受访者使用约会应用程序的几率则有所降低。对不同人口统计学特征(包括 20-40 岁的男性和女性、异性恋、女同性恋、男同性恋和双性恋受访者)进行的分层分析总体上支持这些趋势。值得注意的是,约会应用程序的使用与性生活频率的增加并不相关(调整后的发病率比:1.10;95% CI:0.96-1.26;P = .16):约会应用程序的使用在男性患者和白人中很普遍,并且与性传播感染风险增加、酒精/非法药物使用、既往性经验以及在女同性恋、男同性恋和双性恋群体中的受欢迎程度相关,这些都是公共卫生干预的重要考虑因素。然而,约会应用程序的使用与性接触的增加无关:我们这项研究的优势在于利用了一项针对美国育龄人群的全国性调查,并将重点放在明确界定的结果上,即以性交为目的使用约会应用程序。局限性包括自我报告的调查回答,以及约会应用程序平台的类型和持续时间及其使用情况不够详细:许多社会人口因素,包括男性性别、白种人、性传播感染史、药物和酒精使用以及同性和双性恋吸引力,都与约会应用程序的使用有关。然而,使用约会应用程序并不会增加性生活频率。进一步的研究对于将这些技术融入个人的关系和性动态至关重要。
{"title":"Factors associated with dating app use for sexual \"hookups\" in the United States: insights from the National Survey of Family Growth.","authors":"Albert Ha, Michael Scott, Chiyuan Amy Zhang, Frank Glover, Satvir Basran, Francesco Del Giudice, Michael L Eisenberg","doi":"10.1093/jsxmed/qdae083","DOIUrl":"10.1093/jsxmed/qdae083","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The use of dating applications for matchmaking and sexual exploits (\"hookups\") has increased, and this modern phenomenon has supplanted traditional socialization and relationship formation. To date, sociodemographic data on the use of dating apps has been limited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Aim: &lt;/strong&gt;In this study, we sought to identify predictors associated with the use of dating apps in the United States.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using cross-sectional data from the 2017-2019 National Survey of Family Growth, we examined sociodemographic determinants influencing the use of dating apps to find partners for sexual intercourse. We constructed survey-weighted regression models to study these associations, with additional sensitivity analyses performed within specific subgroups. Furthermore, this study investigated the correlation of app use with sexual frequency.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Outcome: &lt;/strong&gt;Study outcomes were participant data regarding reported use of dating apps for sexual intercourse in the 2017-2019 National Survey of Family Growth.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 11,225 respondents were examined, representing a survey-weighted total of approximately 143,201, 286 Americans. Among them, 757 respondents (6.7%), equating to approximately 8, 818, 743 individuals, reported dating app use for sexual hookups. Regression analysis revealed that factors such as male sex, White race, previous sexual experience, substance/alcohol use, history of sexually transmitted infections, same-sex attraction, and bisexuality increased the likelihood of dating app usage. Conversely, reduced odds of dating app use were observed among Catholics, Protestants, married/widowed individuals, and older respondents. Stratified analyses across various demographics, including male and female individuals aged 20 to 40 years, heterosexual, and lesbian, gay, and bisexual respondents, generally supported these trends. Notably, dating app use did not correlate with increased sexual frequency (adjusted incidence rate ratio: 1.10; 95% CI: 0.96-1.26; P = .16).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinical implications: &lt;/strong&gt;Dating app use is prevalent among male patients and White individuals and correlates with increased sexually transmitted infection risk, alcohol/illicit substance use, past sexual experience, and popularity within the lesbian, gay, and bisexual community, all important considerations for public health interventions. Dating app use, however, was not associated with increased sexual encounters.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Strengths and limitations: &lt;/strong&gt;Strengths of our study were the utilization of a national survey of individuals of reproductive age in the United States and focus on a clearly defined outcome of dating app utilization for the purposes of sexual intercourse. Limitations include self-reported survey responses and insufficient detail on the types and duration of dating app platforms and their use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Many s","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141857055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nonalcoholic fatty liver disease and female sexual dysfunction in Egyptian premenopausal women: is there a link between metabolic syndrome and sexual function? 埃及绝经前妇女的非酒精性脂肪肝和女性性功能障碍:代谢综合征和性功能之间有联系吗?
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae080
Tamer Refaat Fouad, Noha Ezzat Mohamad, Mona Elabd, Rokia Abd-Elwahab, Asmaa Youness Elsary, Tamer Samir Abd-Elghafar, Esam Elshimi, Ahmed Attia

Background: Nonalcoholic fatty liver disease (NAFLD) is a major health problem with a paucity of available information about its impact on female sexual dysfunction (FSD).

Aim: We aimed to study the association between NAFLD and FSD in Egyptian premenopausal women.

Methods: Sexually active married premenopausal women who visited our NAFLD outpatient screening clinic (2019 to 2022) were divided into NAFLD and non-NAFLD (control) groups based on liver ultrasound and fatty liver index data. All participants completed the Arabic Female Sexual Function Index (ArFSFI) questionnaire. The resulting data were used to calculate the domains and total scores. FSD is then graded as follows: no FSD (≥28.2), minimal (21.7-28.1), mild (14.5-21.6), moderate (7.3-14.4), and severe (≤7.2).

Outcomes: We determined the proportions of patients and controls for whom ArFSFI scores indicated dissatisfaction with their sexual lives.

Results: Of 995 women participants whose FSFI scores were available, NAFLD was detected in 487 (48.9%) and absent in 508 (51.1%). The two groups were comparable in age, socioeconomic level, residence, and history of female genital cutting. The NAFLD patients had significantly much lower mean scores for the sexual arousal, lubrication, orgasm, satisfaction, and pain domains of the FSFI (P < .001 for all), while no statistical difference was noticed in the desire domain for NAFLD patients compared with the controls. NAFLD women had significantly lower mean total FSFI scores than the controls (mean [SD] 16.7 [6.8] vs 21.7 [5.1], respectively; P < .001) with higher rates of FSD (98.5% vs 82.1%; P < .001, respectively). Most NAFLD women had higher FSD grades than controls (%): no FSD (1.5, 17.9), minimal (20.6, 51.8), mild (42.5, 38.8), moderate (26.2, 9.4), and severe (10.7, none), respectively.

Clinical implications: Given the high prevalence of FSD in patients with NAFLD, greater attention to FSF could improve the quality of life in patients with NAFLD.

Strengths and limitations: This study was limited by the lack of testing of sex hormones and some other important factors that were not tested (eg, age, socioeconomic level, residence, and female genital cutting), as these characteristics were previously matched. Strengths of the study include the large study size, to our knowledge the largest to date to investigate the possible link between FSD and NAFLD in premenopausal women, together with the inclusion of the detailed version of the validated ArFSFI.

Conclusions: In Egyptian premenopausal women, NAFLD could harm their sexual function.

背景:非酒精性脂肪肝(NAFLD)是一个主要的健康问题,但有关其对女性性功能障碍(FSD)影响的可用信息却很少。目的:我们旨在研究埃及绝经前女性非酒精性脂肪肝与FSD之间的关联:根据肝脏超声波和脂肪肝指数数据,将到我们非酒精性脂肪肝门诊筛查诊所就诊的性活跃已婚绝经前女性(2019 年至 2022 年)分为非酒精性脂肪肝组和非非酒精性脂肪肝组(对照组)。所有参与者都填写了阿拉伯女性性功能指数(ArFSFI)问卷。所得数据用于计算各领域和总分。然后将 FSD 分级如下:无 FSD(≥28.2)、轻度(21.7-28.1)、轻度(14.5-21.6)、中度(7.3-14.4)和重度(≤7.2):结果:我们确定了 ArFSFI 评分显示对性生活不满意的患者和对照组的比例:在995名有FSFI评分的女性参与者中,487人(48.9%)检测出非酒精性脂肪肝,508人(51.1%)未检测出非酒精性脂肪肝。两组患者在年龄、社会经济水平、居住地和女性生殖器切割史方面不相上下。非酒精性脂肪肝患者在 FSFI 的性唤起、润滑、性高潮、满意度和疼痛方面的平均得分明显要低得多(P 临床意义):鉴于FSD在非酒精性脂肪肝患者中的高发率,加强对FSF的关注可提高非酒精性脂肪肝患者的生活质量:本研究的局限性在于缺乏对性激素和其他一些重要因素(如年龄、社会经济水平、居住地和女性生殖器切割)的检测,因为这些特征之前都是匹配的。该研究的优点包括研究规模大,据我们所知,这是迄今为止调查绝经前妇女FSD与非酒精性脂肪肝之间可能存在的联系的规模最大的研究,同时还纳入了经过验证的ArFSFI的详细版本:在埃及绝经前妇女中,非酒精性脂肪肝可能会损害她们的性功能。
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引用次数: 0
Lessons learned from the TRAVERSE trial. 从 TRAVERSE 试验中汲取的经验教训。
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae074
Mohit Khera, Daniela Orozco Rendon, Gal Saffati, Abraham Morgentaler
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引用次数: 0
Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder. 3.6%西地那非乳膏治疗女性性唤起障碍的探索性、2b期、随机、双盲、安慰剂对照临床试验中患者报告结果的1个月回忆与24小时回忆的比较和相关性。
IF 3.3 3区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2024-09-03 DOI: 10.1093/jsxmed/qdae086
Isabella Johnson, Andrea Ries Thurman, Katherine A Cornell, Tara Symonds, Jessica Hatheway, David R Friend, Andrew Goldstein
<p><strong>Background: </strong>Efficacy assessments in clinical trials of treatments for female sexual arousal disorder (FSAD) and other female sexual dysfunction (FSD) diagnoses rely on various patient-reported outcomes (PROs).</p><p><strong>Aims: </strong>We sought to compare 1-month recall PRO measures among participants enrolled in a clinical trial who provided these data without (test population) vs with (control population) use of an at-home, 24-hour recall electronic diary (eDiary), capturing similar data.</p><p><strong>Methods: </strong>Preplanned subset analysis as performed during a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream, 3.6% (sildenafil cream) among healthy premenopausal women with FSAD. Preliminary product efficacy was assessed via 1-month recall and 24-hour recall questionnaires. A subset of the participants, the Evaluation of Recall Subset [ERS] provided PROs via the 1-month recall instruments but did not provide data via the 24-hour recall eDiary.</p><p><strong>Outcomes: </strong>Responses to the 1-month recall instruments were compared among ERS (test) vs non-ERS (control) participants. Among the non-ERS population, correlations between 1-month and 24-hour recall endpoints were calculated.</p><p><strong>Results: </strong>There were no significant differences in the study co-primary 1-month recall efficacy endpoints, the Arousal Sensation (AS) domain of the 28-item Sexual Function Questionnaire (SFQ28) and the Female Sexual Distress Scale - Desire, Arousal, Orgasm question 14, among ERS vs non-ERS participants during the initial 1-month no-drug run-in period or the 1-month single-blind placebo run-in period (P values > .47). Scores on these 1-month recall PROs continued to be similar after randomization for sildenafil cream (P values > .30) and placebo cream (P values > .20) assigned ERS and non-ERS participants during the 3-month double-blind dosing period. There were strong correlations between the SFQ28 AS and eDiary AS scores during the no-drug run-in (R = 0.79, P < .01) and the single-blind run-in (R = 0.73 P < .001). During the double-blind dosing period, the SFQ28 AS score continued to be highly correlated with the eDiary AS score among sildenafil cream users (R = 0.83; P < .001) and placebo cream users (R = 0.8; 2 P < .001).</p><p><strong>Clinical implications: </strong>There was no evidence that 1-month recall PRO instruments introduce recall bias; assessing arousal sensations with 24-hour vs 1-month PRO instruments is similar and either method could be used to assess efficacy depending on study objectives.</p><p><strong>Strengths and limitations: </strong>This preplanned subset analysis compared efficacy of PROs based on recall duration. While the subset was preplanned, the study was powered to detect significant differences in the primary efficacy objectives, not among this subset analyses.</p><p><strong>Conclusion: </strong>These data will be used in planning futu
背景:目的:我们试图比较未使用(试验人群)与使用(对照人群)24小时在家回忆电子日记(eDiary)的临床试验参与者的1个月回忆PRO测量,这些参与者提供了这些数据,并捕获了类似的数据:在对患有FSAD的绝经前健康女性进行西地那非乳膏(3.6%)(西地那非乳膏)的2b期探索性、随机、安慰剂对照、双盲研究期间,进行了预先计划的子集分析。通过 1 个月回忆问卷和 24 小时回忆问卷对产品的初步疗效进行了评估。一部分参与者(即 "回忆评估子集"[ERS])通过 1 个月回忆问卷提供了 PROs,但没有通过 24 小时回忆电子日记提供数据:比较了 ERS(测试)与非ERS(对照)参与者对 1 个月回忆工具的反应。在非ERS人群中,计算了1个月和24小时回忆终点之间的相关性:结果:在最初的 1 个月无药试验期或 1 个月单盲安慰剂试验期,ERS 与非ERS 参与者在研究的共同主要 1 个月回忆疗效终点,即 28 项性功能问卷(SFQ28)中的唤醒感觉(AS)领域和女性性困扰量表--欲望、唤醒、高潮问题 14,没有明显差异(P 值大于 0.47)。在 3 个月的双盲给药期间,西地那非乳膏(P 值 > .30)和安慰剂乳膏(P 值 > .20)在随机分配给 ERS 和非 ERS 参与者后,这些 1 个月回忆 PROs 的得分仍然相似。在无药试验期间,SFQ28 AS 和 eDiary AS 分数之间存在很强的相关性(R = 0.79,P 临床影响):没有证据表明1个月回忆的PRO工具会带来回忆偏差;用24小时与1个月的PRO工具评估唤醒感觉相似,根据研究目标,两种方法都可用于评估疗效:这项预先计划的子集分析比较了基于回忆持续时间的 PRO 的疗效。虽然子集是预先计划的,但研究的作用是检测主要疗效目标的显著差异,而不是子集分析之间的显著差异:这些数据将用于规划未来西地那非乳膏治疗 FSAD 的疗效评估:该临床试验已在 ClinicalTrials.gov 登记,编号为 NCT04948151。
{"title":"Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder.","authors":"Isabella Johnson, Andrea Ries Thurman, Katherine A Cornell, Tara Symonds, Jessica Hatheway, David R Friend, Andrew Goldstein","doi":"10.1093/jsxmed/qdae086","DOIUrl":"10.1093/jsxmed/qdae086","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Efficacy assessments in clinical trials of treatments for female sexual arousal disorder (FSAD) and other female sexual dysfunction (FSD) diagnoses rely on various patient-reported outcomes (PROs).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Aims: &lt;/strong&gt;We sought to compare 1-month recall PRO measures among participants enrolled in a clinical trial who provided these data without (test population) vs with (control population) use of an at-home, 24-hour recall electronic diary (eDiary), capturing similar data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Preplanned subset analysis as performed during a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream, 3.6% (sildenafil cream) among healthy premenopausal women with FSAD. Preliminary product efficacy was assessed via 1-month recall and 24-hour recall questionnaires. A subset of the participants, the Evaluation of Recall Subset [ERS] provided PROs via the 1-month recall instruments but did not provide data via the 24-hour recall eDiary.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Outcomes: &lt;/strong&gt;Responses to the 1-month recall instruments were compared among ERS (test) vs non-ERS (control) participants. Among the non-ERS population, correlations between 1-month and 24-hour recall endpoints were calculated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;There were no significant differences in the study co-primary 1-month recall efficacy endpoints, the Arousal Sensation (AS) domain of the 28-item Sexual Function Questionnaire (SFQ28) and the Female Sexual Distress Scale - Desire, Arousal, Orgasm question 14, among ERS vs non-ERS participants during the initial 1-month no-drug run-in period or the 1-month single-blind placebo run-in period (P values &gt; .47). Scores on these 1-month recall PROs continued to be similar after randomization for sildenafil cream (P values &gt; .30) and placebo cream (P values &gt; .20) assigned ERS and non-ERS participants during the 3-month double-blind dosing period. There were strong correlations between the SFQ28 AS and eDiary AS scores during the no-drug run-in (R = 0.79, P &lt; .01) and the single-blind run-in (R = 0.73 P &lt; .001). During the double-blind dosing period, the SFQ28 AS score continued to be highly correlated with the eDiary AS score among sildenafil cream users (R = 0.83; P &lt; .001) and placebo cream users (R = 0.8; 2 P &lt; .001).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinical implications: &lt;/strong&gt;There was no evidence that 1-month recall PRO instruments introduce recall bias; assessing arousal sensations with 24-hour vs 1-month PRO instruments is similar and either method could be used to assess efficacy depending on study objectives.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Strengths and limitations: &lt;/strong&gt;This preplanned subset analysis compared efficacy of PROs based on recall duration. While the subset was preplanned, the study was powered to detect significant differences in the primary efficacy objectives, not among this subset analyses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;These data will be used in planning futu","PeriodicalId":51100,"journal":{"name":"Journal of Sexual Medicine","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141767978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Journal of Sexual Medicine
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