NCT01377142已完成不适用
Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 8
- 主要终点
- The primary outcome measure will be surgical "success" or "failure" as a dichotomous outcome 1 year after surgery. Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms.
研究概览
简要总结
The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.
详细描述
This will be a prospective parallel cohort study comparing a laparoscopic sacral hysteropexy (LSHP) to a vaginal Uphold hysteropexy (VUHP). Symptomatic and anatomic improvement of pelvic organ prolapse will be evaluated at 3 months and 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Desires surgical treatment for uterovaginal prolapse.
- •Symptomatic stage II-IV POP including:
- •cystocele (AA or BA > or = 0) by POP-Q and
- •apical descent below the mid-vagina (point C > -(TVL / 2)) by the POP-Q and
- •a positive response to questions 3 of the PFDI 20: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? (Appendix A)
- •Eligible for and undergoing one of the following procedures: laparoscopic sacral hysteropexy (LSHP) or Vaginal Uphold hysteropexy (VUHP)
- •Female age 40 to
- •Completed childbearing confirmed by subject or practicing reliable form of birth control defined as permanent sterilization, hormonal contraception, abstinence, IUD.
- •Normal size uterus (length less than 10 cm) on bimanual exam or ultrasound within the past 6 months.
排除标准
- •Prior hysterectomy.
- •Patient with synthetic material placed to augment previous pelvic organ prolapse repair. (previous prolapse repair without synthetic mesh is acceptable).
- •Current vaginal or pelvic foreign body complications (including but not limited to erosion, fistula, abscess). This includes foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
- •Desires hysterectomy at the time of prolapse repair.
- •Cervical elongation with anticipated need for cervical shortening at the time of prolapse repair as determined by surgeon.
- •History of cervical dysplasia (diagnosed within the past 5 years) or increased risk of cervical dysplasia (HIV, immunocompromise, DES exposure), chronic pelvic pain, uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, cancer) or any uterine disease that would preclude prolapse repair with uterine preservation in the opinion of the surgeon.
- •Any postmenopausal bleeding in the past 12 months (regardless of endometrial biopsy or ultrasound results) or any postmenopausal bleeding more than 12 months prior without adequate evaluation in the opinion of the investigator.
- •Premenopausal women with menstrual issues including irregular bleeding, menorrhagia, dysmenorrhea,
- •Pregnancy (confirmed before surgery with a pregnancy test).
结局指标
主要结局
The primary outcome measure will be surgical "success" or "failure" as a dichotomous outcome 1 year after surgery. Subjects will be considered a success if they meet the definitions of anatomic cure and deny vaginal bulging symptoms.
时间窗: 12 months
Anatomic sure is defined as cervix above mid-vagina, and no prolapse beyond the hymen and no surgical treatment for pelvic organ prolapse or pessary use. Symptomatic cure is defined as the absence of vaginal bulge symptoms as indicated by a negative response question 3 of the pelvic floor distress inventory- 20.
次要结局
- Symptomatic improvement(3months and 12 months)
- Shortterm morbidity(6 weeks, 3 months, 12 months)
- Anatomic outcomes(12 months)
- Pain and functional activity(6 weeks and 6 months)
研究者
研究点 (8)
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