Yuan Nance, Feldman Alexandra Terris, Chin Patrick, Zaliznyak Michael, Rabizadeh Susan, Garcia Maurice M
Cedars-Sinai Transgender Surgery and Health Program, Cedars-Sinai Medical Center, Los Angeles, CA, USA; Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Cedars-Sinai Transgender Surgery and Health Program, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Sex Med. 2022 Oct;10(5):100545. doi: 10.1016/j.esxm.2022.100545. Epub 2022 Jul 30.
Permanent genital hair removal is required before gender-affirming vaginoplasty to prevent hair-related complications. No previous studies have directly compared the relative efficacy, costs, and patient experiences with laser hair removal (LHR) vs electrolysis treatments. Food and Drug Administration (FDA) oversight of medical devices is poorly understood and commonly misrepresented, adversely affecting patient care.
This study compares treatment outcomes of electrolysis and LHR for genital hair removal and investigates FDA regulation of electrolysis and LHR devices.
Penile-inversion vaginoplasty and shallow-depth vaginoplasty patients completed surveys about their preoperative hair removal, including procedure type, number/frequency of sessions, cost, and discomfort. Publicly available FDA-review documents and databases were reviewed.
Compared to electrolysis, LHR was associated with greater efficiency, decreased cost, decreased pain, and improved patient satisfaction.
Of 52 total (44 full-depth and 8 shallow-depth) vaginoplasty patients, 22 of 52 underwent electrolysis only, 15 of 52 underwent laser only, and 15 of 52 used both techniques. Compared to patients that underwent LHR only, patients that underwent only electrolysis required a significantly greater number of treatment sessions (mean 24.3 electrolysis vs 8.1 LHR sessions, P < .01) and more frequent sessions (every 2.4 weeks for electrolysis vs 5.3 weeks for LHR, P < .01) to complete treatment (defined as absence of re-growth over 2 months). Electrolysis sessions were significantly longer than LHR sessions (152 minutes vs 26 minutes, P < .01). Total treatment costs for electrolysis ($5,161) were significantly greater than for laser ($981, P < .01). Electrolysis was associated with greater pain and significantly increased need for pretreatment analgesia, which further contributed to higher net costs for treatment with electrolysis vs laser. Many LHR and electrolysis devices have been FDA-cleared for safety, but the FDA does not assess or compare clinical efficacy or efficiency.
For patients with dark-pigmented hair, providers should consider LHR as the first-line treatment option for preoperative hair removal before gender-affirming vaginoplasty.
This is the first study to compare electrolysis and LHR for genital hair removal. The discussion addresses FDA review/oversight of devices, which is commonly misrepresented. Limitations include the survey format for data collection.
When compared with electrolysis, LHR showed greater treatment efficiency (shorter and fewer treatment sessions to complete treatment), less pain, greater tolerability, and lower total cost. Our data suggests that, for patients with dark genital hair, providers should consider recommending laser as the first-line treatment for permanent genital hair removal before vaginoplasty. Yuan N, Feldman A, Chin P, et al. Comparison of Permanent Hair Removal Procedures before Gender-Affirming Vaginoplasty: Why We Should Consider Laser Hair Removal as a First-Line Treatment for Patients Who Meet Criteria. Sex Med 2022;10:100545.
在进行性别确认阴道成形术前,需要永久性去除生殖器毛发以预防与毛发相关的并发症。此前尚无研究直接比较激光脱毛(LHR)与电解脱毛治疗的相对疗效、成本及患者体验。美国食品药品监督管理局(FDA)对医疗器械的监管情况鲜为人知且常被误解,这对患者护理产生了不利影响。
本研究比较电解脱毛和激光脱毛用于生殖器毛发去除的治疗效果,并调查FDA对电解脱毛和激光脱毛设备的监管情况。
阴茎倒置阴道成形术和浅深度阴道成形术患者完成了关于术前脱毛的调查,包括手术类型、治疗次数/频率、成本和不适感。查阅了公开的FDA审评文件和数据库。
与电解脱毛相比,激光脱毛效率更高、成本降低、疼痛减轻且患者满意度提高。
在总共52例(44例全深度和8例浅深度)阴道成形术患者中,52例中有22例仅接受电解脱毛,52例中有15例仅接受激光脱毛,52例中有15例同时使用了两种技术。与仅接受激光脱毛的患者相比,仅接受电解脱毛的患者完成治疗(定义为2个月内无毛发再生)所需的治疗次数显著更多(电解脱毛平均24.3次 vs 激光脱毛8.1次,P <.01),且治疗频率更高(电解脱毛每2.4周一次 vs 激光脱毛每5.3周一次,P <.01)。电解脱毛的治疗时间显著长于激光脱毛(152分钟 vs 26分钟,P <.01)。电解脱毛的总治疗成本(5161美元)显著高于激光脱毛(981美元,P <.01)。电解脱毛会带来更大的疼痛,且预处理镇痛的需求显著增加,这进一步导致电解脱毛治疗的净成本高于激光脱毛。许多激光脱毛和电解脱毛设备已获得FDA的安全许可,但FDA并不评估或比较临床疗效或效率。
对于毛发颜色较深的患者,在进行性别确认阴道成形术前,医疗服务提供者应将激光脱毛作为术前毛发去除的一线治疗选择。
这是第一项比较电解脱毛和激光脱毛用于生殖器毛发去除的研究。讨论涉及FDA对设备的审评/监管情况,这一情况常被误解。局限性包括数据收集采用的调查形式。
与电解脱毛相比,激光脱毛显示出更高的治疗效率(完成治疗所需的治疗时间更短、次数更少)、疼痛减轻、耐受性更好且总成本更低。我们的数据表明,对于生殖器毛发颜色较深的患者,医疗服务提供者应考虑推荐激光脱毛作为阴道成形术前永久性去除生殖器毛发的一线治疗方法。袁N、费尔德曼A、钦P等。性别确认阴道成形术前永久性脱毛程序的比较:为何我们应将激光脱毛视为符合标准患者的一线治疗方法。性医学2022;10:100545 。