Early Feasibility Prospective Open-Label Study to Assess the Function of a Novel Pessary for the Non-Surgical Management of Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination)
研究概览
简要总结
This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse (POP). Recruited patients will have Stage II POP or greater and will be current users of a legally marketed vaginal pessary. In a single visit, data will be collected on the performance and comfort of the subject's current pessary. After placement of a study pessary, comparative data will be collected between subject's current pessary and the study pessary on ability to support prolapse. The study pessary's function will be assessed under controlled circumstances. The patient will have her current pessary replaced at the conclusion of the visit. Results will be used to inform future design modifications of the study pessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Women with Stage II pelvic organ prolapse or greater
- •Current ring style or Gellhorn pessary users inclusive of sizes 1.5"-3.5"
- •Capable of giving informed consent
排除标准
- •Pregnancy
- •Deep vaginal erosion noted with removal of current pessary
- •Presence of vesicovaginal fistula
- •Presence of rectovaginal fistula
- •Vaginal, rectal, or bladder tumor
- •Inflammatory Bowel Disease
- •Presence of open wound or tear near vagina or anus by exam prior to removal of current pessary
- •Current vaginal or urinary infection requiring treatment
- •Previous pelvic floor surgery in last 12 months
- •Congenital malformation of bladder, rectum, or vagina
- •Significant medical condition interfering with study participation (psychologic, neurologic, active drug/alcohol abuse, etc.)
- •Planning pregnancy in next 6 months
结局指标
主要结局
The Ability of the Study Device to be Retained Throughout Regular Activity (by Vaginal Examination)
时间窗: During treatment - within 1 hour
With the study pessary in place, the subject will be asked to ambulate for 10 minutes and attempt to void. Following these activities, whether the pessary was retained or expelled will be recorded.
The Ability of the Study Device to be Retained During Valsalva Compared to the Ability of the Subject's Current Pessary to be Retained During Valsalva (Change in Distance Between Current Pessary and Study Pessary to Leading Edge to the Hymen)
时间窗: During treatment - within 1 hour
The subject will be asked to Valsalva with their current pessary in place, and the distance from the leading edge of the current pessary to the hymen will be measured in centimeters. After the current pessary is removed and with the study pessary in place, the subject will be asked to Valsalva again. The distance from the leading edge of the study pessary to the hymen will be measured in centimeters. In order to assess the ability of the study pessary to function and be retained, the measurements will be compared.
次要结局
- Discomfort Experienced With Insertion of the Study Pessary Subtracted From the Discomfort Experienced With Insertion of the Subject's Current Pessary (Change in VAS) [Positive Score Indicates Lower Discomfort With Study Pessary](During treatment - within 1 hour)
- Shape of the Study Pessary During Expulsion if it is Not Able to be Retained (by Vaginal Examination)(During treatment - within 1 hour)
- Orientation of the Study Pessary Stem Following Regular Activity (by Vaginal Examination)(During treatment - within 1 hour)
- Global Comfort Associated With Use of the Study Pessary (by Verbal Description)(Post treatment - within or at 1 hour)
- Discomfort Experienced With Removal of the Study Pessary Subtracted From the Discomfort Experienced With Removal of the Subject's Current Pessary (Change in VAS) [Positive Score Indicates Lower Discomfort With Study Pessary](During treatment - within 1 hour)