Prospective Randomized Trial Comparing Treatment of Dyspareunia With Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel in the Setting of Breast Cancer Survivors.
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Female Sexual Function Index (FSFI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
研究概览
简要总结
This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse in women who are breast cancer survivors. This study will also be looking at whether or not the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function before and after treatment.
详细描述
This is a randomized trial to determine the comparative effectiveness of the CO2RE laser device relative to topical lidocaine in treating dyspareunia among breast cancer survivors. The large and growing population of breast cancer survivors experience a significant burden of urogenital symptoms including dyspareunia. Several studies have evaluated the feasibility and effectiveness of CO2 lasers for the treatment of symptomatic vulvovaginal atrophy in postmenopausal women suggesting improvements in atrophy symptoms with favorable histological and microscopic changes. There is little know about the effectiveness of CO2 laser therapy in breast cancer survivors.
Patients who are breast cancer survivors experiencing dyspareunia and desiring intervention will be randomized to two cohorts: (1) Treatment with the CO2RE laser or (2) application of 4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal penetration. The primary outcome will be the overall as well as lubrication, satisfaction, and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes will be according to other validated pain and pelvic floor symptom instruments.
Following initiation of treatment, both groups will follow up at one-week, 1-month, 3-months, and 6-months. At the 3-month assessment, subjects in the lidocaine arm will be given the option to undergo CO2RE laser therapy. A combination of validated and non-validated physical exam and survey instruments will be utilized at each visit in order to assess pelvic floor function, bowel and bladder function, and sexual function before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Subjects included must be female breast cancer survivors over the age of 18, sexually active (at least 4 episodes of sexual intercourse per month), and find intercourse painful. Subjects must also be English speaking and able to give informed consent.
排除标准
- •Subjects will be excluded if pregnant, has not had breast cancer, does not have painful intercourse secondary to treatment received for their breast cancer, is not English speaking, or lacks the ability to sign informed consent.
研究组 & 干预措施
CO2RE Laser
This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.
干预措施: CO2RE fractional laser therapy (Device)
4% Topical Lidocaine Gel
This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).
干预措施: 4% Topical Lidocaine Gel (Drug)
结局指标
主要结局
Female Sexual Function Index (FSFI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
时间窗: 9 months
The Female Sexual Function Index (FSFI) is a survey instrument used to determine the level of sexual function or dysfunction in females. It is comprised of a 19 item questionnaire focused on sexual functioning. There are six domains assessed: desire, arousal, lubrication, orgasm, satisfaction, and pain. The subject is to consider each of the questions in the context of the previous 4 weeks. The scores of each of the domains are then calculated into a final score. Initial and follow-up assessments will allow comparisons across this instrument as well as all the secondary and other pre-specified outcome measures.
次要结局
- 3 Incontinence Questions (3-IQ) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.(9 months)
- Colon Rectal Anal Distress Inventory (CRADI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.(9 months)
- Numeric Pain Rating Scale (NPRS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.(9 months)
- Incontinence Severity Index (ISI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.(9 months)
- Patient Global Impression of Severity (PGI-S) score before treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.(9 months)
- Patient Global Impression of Improvement (PGI-I) score after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.(9 months)
- Satisfaction with Decision (SDS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.(9 months)
研究者
James Whiteside
Principal Investigator
University of Cincinnati