Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up
试验速览
- 阶段
- 不适用
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Patient satisfaction
研究概览
简要总结
Objectives: Pelvic organ prolapse (POP) is a common condition for which pessaries are commonly used in conservative treatment. Despite their prevalence, there is no literature to guide the management of pessaries. Our objective is to determine whether patients managed with a pessary for POP are more satisfied with follow-up at 3 or 6 month intervals and if there is any difference in complications rates between the two groups.
Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in the group randomized to 6 month follow-up intervals and that there will be no difference in complication rates between the two follow-up groups.
Method: The investigators will conduct a prospective randomized control trial comparing patient satisfaction and complication rates between patients with pessaries randomized to either 3 or 6 month follow-up intervals over 1 year.
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
- 否
入选标准
- •Females with POP who have opted for conservative management with a pessary
- •Able to read and write English
- •First time pessary users
- •Successful fitting with a covered ring or Gellhorn pessary, as determined at the usual early follow-up visit 2-4 weeks after initial fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
- •Patients agree to use vaginal estrogen (either tablet or cream twice weekly) during the study period; patients may not use a vaginal estrogen ring since this requires changing every 3 months, and will interfere with the study follow-up schedule
- •Exclusion criteria:
- •Current presence of vaginal bleeding, vaginal abrasions or ulcers, or vaginal infection
- •Significant cognitive impairment
- •Pessary used for indication other than POP (ie. urinary incontinence)
- •Use of a pessary that is not a covered ring or Gellhorn (i.e exclude cube, donut, etc.)
- •Contraindications to vaginal estrogen
- •Unsuccessful pessary fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
排除标准
- 未提供
结局指标
主要结局
Patient satisfaction
时间窗: At 12 months from study enrollment
To determine if patients managed with a pessary for POP are more satisfied with follow-up at 6 or 12 weeks over a one year period.
次要结局
- Pessary associated complications(Checked at all follow-up visits (3 and 6 months, depending on study group))