Timing of Pessary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- vaginal epithelial abnormalities
研究概览
简要总结
This is a prospective trial to investigate optimal timing of care for vaginal pessaries. A vaginal pessary is a silicone device that is placed in the vagina to support the pelvic organs of a woman who has pelvic organ prolapse. Some women are willing and able to remove their own pessary on a regular basis. In women who are either unwilling or unable to remove their own pessary, complete pessary care is provided in the urogynecology office. Complete pessary care involves regular removal and cleaning of the pessary with a vaginal examination. In our practice, the investigators typically remove vaginal pessaries and examine the vagina every 3 months in patients for whom the investigators provide complete pessary care. Interval of pessary removal varies widely between practitioners. In the literature, removal intervals vary from weekly to yearly. In this study, the investigators will randomize participants to pessary care with removal every 12 weeks or every 24 weeks.
详细描述
This is a prospective, randomized, non-blinded trial of office-based pessary care. The primary outcome of this study is vaginal epithelial abnormalities, including granulation tissue and ulceration. Secondary outcomes include participant satisfaction, degree of bother due to vaginal discharge, number of unscheduled visits and progression of pelvic organ prolapse quantification score (POPQS).
At baseline (visit 1; see "Visit Schedule", below), women who have consented to participate will be randomized 1:1 to one of two groups:
- routine group: pessary care with removal and cleaning every 12 ± 2 weeks, or
- extended group: pessary care with removal and cleaning every 24 ± 2 weeks.
Randomization will be performed using a randomization scheme available through Excel. Each consecutive/sequential participant will be assigned to whichever group corresponds to that sequential study entry number.
For both groups, the pessary will be removed and cleaned and a vaginal examination will be performed at every visit regardless of complaints. The only difference will be frequency of visits. All pelvic examinations will be performed by the same individual.
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
- •female sex
- •age greater than 17 years
- •able and willing to participate
- •patients who are currently wearing a ring, gellhorn, or incontinence dish pessary to treat pelvic organ prolapse and/or incontinence
排除标准
- •age less than 18 years
- •unable/unwilling to participate
- •patients who do not wear a pessary
- •patients wearing a pessary that is not a ring or a gellhorn
- •presence of vaginal granulation tissue
- •erosions, or fistula, patients who perform pessary self-care
研究组 & 干预措施
Routine
Subjects will continue with regular pessary care every 12 weeks.
Extended
Subjects will have extended time between pessary care visits which will occur every 24 weeks.
干预措施: Extended timing of pessary care (Other)
结局指标
主要结局
vaginal epithelial abnormalities
时间窗: Routine group: change from baseline in vaginal epithelial abnormalities at 12 weeks, 24 weeks, 36 weeks, 48 weeks. Extended group: change from baseline in vaginal epithelial abnormalities at 24 weeks, 48 weeks
this will be evaluated by vaginal examination at each study visit
次要结局
- Progression of Pelvic Organ Prolapse Quantification Score(Change from baseline in pelvic organ prolapse quantification score at final study visit (48 weeks))
- Degree of bother due to vaginal discharge(Routine group: change from baseline in degree of bother due to vaginal discharge at 12 weeks, 24 weeks, 36 weeks, 48 weeks. Extended group: change from baseline in degree of bother due to vaginal discharge at 24 weeks, 48 weeks)
- Patient satisfaction(final study visit (48 weeks))