A study protocol of vaginal laser therapy in gynecological cancer survivors

Abstract

Objectives: Sexual dysfunction and radiation cystitis are common adverse events following radiotherapy for gynecological cancer (GC). This study aims to assess the efficacy of intravaginal CO₂ laser on GC survivors with dyspareunia following pelvic radiation and/or brachytherapy.

Methods: This is the study protocol of a randomized double-blind placebo-controlled trial. All participants will receive five therapies (active or placebo) at monthly intervals. Outcomes will include a 10-cm visual analog scale measuring dyspareunia, vaginal dryness, and other symptom intensity, 3-day voiding diary, Day-to Day Impact of Vaginal Aging questionnaire, Female Sexual Function Index, European Organization for Research and Treatment of Cancer Quality of Life questionnaire cervical cancer module, Urogenital Distress Inventory short form, King's Health Questionnaire, International Consultation on Incontinence Questionnaire short form/female lower urinary tract symptoms, patient perception of improvement, sexual satisfaction of male partners, vaginal maturation value, and Vaginal Health Index. Differences between groups will be assessed at baseline and 1, 3, 6, 9, and 12 months following the five laser therapies.

Results: As this is a study protocol, the study is ongoing with an expected end of recruitment and analysis date of 2021.

Conclusion: Pelvic radiotherapy for GC increases the 5-year survival rate but with a negative impact on women’s quality of life due to sexual dysfunction and radiation cystitis onset. With this study, CO₂ laser therapy will be evaluated for the first time in GC survivors treated with radiotherapy.

ClinicalTrials.gov registration number: NCT03714581

摘要

目的：性功能障碍和放射性膀胱炎是妇科癌症(GC)患者放疗后常见的并发症。本研究旨在评估, 经阴道CO2激光治疗在进行盆腔放疗和/或近距离放疗后GC存活者中排便困难的疗效。

方法：研究方案：这是一项随机双盲、安慰剂对照试验。所有参与者将每隔一个月接受五次治疗(主动或安慰剂)。观察结果指标包括应用10cm视觉模拟评分法测量排尿困难、阴道干燥和其他症状强度, 3天的排尿记录, 阴道萎缩症状日常量表, 女性性功能指数, 欧洲癌症研究和治疗组织生活质量问卷宫颈癌模块, 泌尿生殖障碍量表, 国王健康问卷, 国际尿失禁咨询委员会尿失禁问卷表/女性下尿路问卷、患者对改善的自我感觉、男性伴侣的性满意度、阴道细胞成熟值和阴道健康指数。在完成五次激光治疗后评估各组之间的差异, 包括基线以及治疗后1, 3, 6, 9和12个月的治疗情况。

结果：这是一项研究方案, 这项研究正在进行中, 预计2021年结束招募和进行数据分析。

结论：GC的盆腔放疗增加了患者的5年生存率, 但由于性功能障碍和放射性膀胱炎的并发症, 对女性的生活质量产生了负面影响。通过这项研究, 首次评估CO2激光治疗对接受放射治疗的GC存活着的疗效。

Keywords:

• Vaginal atrophy
• cervical cancer
• vaginal stenosis
• sexual function
• lower urinary tract symptoms
• brachytherapy
• laser

Potential conflict of interest

No potential conflict of interest was reported by the authors.

Source of funding

Nil