A Comparison of Continence Pessary to a Disposable Intravaginal Device in the Management of Stress Urinary Incontinence: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Treatment Success
研究概览
简要总结
This is a multi-centered randomized controlled trial of women with stress urinary incontinence or stress predominant mixed urinary incontinence who desire non-surgical therapy.
详细描述
In this randomized trial, eligible patients who provide written consent for participation will be enrolled. At enrollment we will collect baseline demographic data and ask participants to complete questionnaires and a 3-day bladder diary. Subjects will be randomized in a 1:1 ratio to continence pessary or disposable intravaginal device.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older (based on disposable intravaginal device manufacturing recommendations).
- •SUI or SUI-predominant mixed incontinence
- •English-speaking
排除标准
- •Pregnancy
- •Current symptomatic urinary tract infection (UTI).
- •Postmenopausal bleeding of unknown etiology
- •Neurogenic bladder
- •Urinary retention (PVR >150mL obtained via bladder scan or catheterization)
- •Pelvic organ prolapse past the hymen as assessed by POP-Q examination
- •Inability to complete questionnaires in English or comply with study protocol
- •Contraindication to pessary or disposable intravaginal device use or prior treatment or experience with either intervention.
- •Prior surgery for stress urinary incontinence
研究组 & 干预措施
Continence Pessary
Participants randomized to the continence pessary will be fitted for a pessary by a clinician at enrollment and they will be taught how to remove and reinsert the device. Per usual clinical practice they will be instructed to call with any concerns and scheduled for a return visit in 2 weeks for a follow-up to assess fit and comfort and undergo refitting if necessary.
干预措施: Continence Pessary (Device)
Disposable Intravaginal Device
Participants randomized to the intravaginal device will be given a sizing kit in the office, asked to select a size and provided with a 2-week supply of the appropriately sized devices. In accordance with manufacturer guidelines, participants will be instructed that the device is to be used for no more than 8 hours per 24-hour period and that each device is single use only. Participants will return in 2 weeks for a follow-up visit to assess fit and comfort, undergo resizing as necessary and receive an additional 2 week supply of the appropriately sized devices.
干预措施: Poise Impressa (Disposable Intravaginal Device) (Device)
结局指标
主要结局
Treatment Success
时间窗: 4 weeks
Success of stress urinary incontinence treatment is defined as a response of "very much better" or "much better" on the Patient Global Impression of Improvement (PGI-I).
次要结局
- Adverse Events(4 weeks)
- Validated Questionnaires(4 weeks)
- Satisfaction With Device(4 weeks)
- 6 Month Follow up(6 months)
研究者
Silpa Nekkanti
MD
Ohio State University