Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months
研究概览
简要总结
This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers.
In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP).
Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of a gynecologic cancer
- •No evidence of disease at time of inclusion in the study
- •Postmenopausal (either surgical or natural menopause)
- •Self report of sexual dysfunction that did not predate cancer diagnosis
- •Suspected physical component to sexual dysfunction with the participant, not sexual partner
- •Desire to improve sexual function
- •ECOG Performance status score of 2 or better
- •Six months or greater from last surgical and/or radiation treatment
排除标准
- •History of sexual reassignment
- •Presence of vaginal fistula
- •Does not desire to improve sexual function
- •Already using the vaginal renewal program
- •Not fluent in English
- •Incarceration
结局指标
主要结局
Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months
时间窗: At baseline and 6 months
Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.
次要结局
- Vaginal Length(At baseline and 6 months)
- FACT-G Score(At baseline and 6 months)
- Change in Marinoff Scale at 6 Months(At baseline and 6 months)