The Affect of Erbium Laser Treatments on Vaginal Looseness and Sexual Dysfunction in Pre-menopausal Female Individuals.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Female sexual function index.
研究概览
简要总结
Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.
详细描述
Patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.
Patients will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.
Follow up after treatment cessation will be for 12 months post-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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women.
- •Women with vaginal looseness and sexual dysfunction as a primary complaint.
排除标准
- •Vaginal bleeding of unknown source.
- •Repeated vaginal infections.
- •Known or suspected cervical pre-malignant neoplasia.
- •Previous treatment with vaginal laser or other forms of energy-based treatment modalities.
- •Pregnancy.
- •Current pelvic inflammatory disease or urinary tract infection.
- •Vaginal surgery during the year preceding study participation.
- •Treatment with systemic or vaginal hormone replacement therapy.
- •Current pelvic floor physiotherapy.
研究组 & 干预措施
Erbium laser treatment
Women with vaginal looseness and sexual dysfunction treated with real laser.
干预措施: Erbium laser (Device)
Sham laser treatment
Women with vaginal looseness and sexual dysfunction treated with sham laser.
干预措施: Sham Laser (Device)
结局指标
主要结局
Female sexual function index.
时间窗: From recruitment up to 15 months.
Female sexual function index scores pre- and post-treatment. Minimal score is 2, maximal score is 36. Thee higher the score, the improved the sexual function is.
次要结局
- Vaginal health index(From recruitment up to 15 months.)
- Pelvic floor disability index.(From recruitment up to 15 months.)
- Monthly sexual intercourse rate(From recruitment up to 15 months.)
- Vaginal laxity questionnaire.(From recruitment up to 15 months.)
研究者
ROY LAUTERBACH MD
Principal investigator
Rambam Health Care Campus