The POMEGRANATE Trial: A Randomized Controlled Trial Comparing Pessary Home Management of Reia Pessary Versus Standard of Care Pessary for Treatment of Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 218
- 试验地点
- 13
- 主要终点
- Satisfaction with treatment
研究概览
简要总结
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 200 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events.
Specific Aims
Aim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 3: To compare ease/difficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary.
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
- •English-speaking natal females ≥ 18 years of age
- •Willing to self-maintain (insert/remove) pessary
- •Pessary naïve with Stage II-IV POP desiring conservative management with a pessary
- •Primary indication for use of pessary is treatment of pelvic organ prolapse
排除标准
- •Primary indication for pessary use is for management of stress urinary incontinence
- •Prior mesh-augmented prolapse repair (i.e. transvaginal mesh, sacrocolpopexy)
- •Short vaginal length (TVL < 8cm) or subjective vaginal narrowing
- •Vaginal fistula (e.g. rectovaginal, vesicovaginal or any type of fistula involving the vagina)
- •Vaginal, rectal or bladder malignancy
- •Genitourinary infection requiring treatment (See below 1)
- •Ongoing treatment for vaginal infections (e.g., chronic bacterial vaginosis) (See below 2)
- •Inflammatory bowel disease (Crohn's or ulcerative colitis)
- •Pelvic or anorectal chronic pain
- •Pelvic floor surgery within the past 6 months or planning to undergo pelvic floor surgery
- •Congenital malformation of the bladder, rectum or vagina
- •Pregnant or planning pregnancy in the next 6 months
- •Prior failure of pessary for POP
- •History of hydroureter, hydronephrosis, or impaired renal function secondary to prolapse
- •Patients with acute vaginal infections will be eligible for enrollment 2 weeks after completing treatment with resolution of symptoms
- •OK to be on prophylactic/suppressive therapy for HSV
研究组 & 干预措施
Reia System
Participants receiving the commercially available RS will be fit with one of three available pessary sizes and will receive an applicator corresponding to their pessary size.
干预措施: Reia System (Device)
Standard Pessary Care
Participants receiving SPC will be fit with a Gellhorn pessary or ring with/without support without knob pessary per standard clinical protocol.
干预措施: Standard of Care Pessary (Device)
结局指标
主要结局
Satisfaction with treatment
时间窗: 6 months
The primary outcome will be measured by participant response to the question "How satisfied or unsatisfied are you with your ability to use and manage the pessary provided to you?" with response collected via VAS ranging from "0mm = very unsatisfied" to "100mm = very satisfied" with 50mm = neutral (neither satisfied nor unsatisfied).
次要结局
- Total self-management events(6 months)
- Patient Global Impression of Severity (PGI-S)(6 months)
- Patient Global Symptoms Control Rating Scale (PGSC)(6 months)
- Participant view of importance of ability to self-maintain pessary(6 months)
- Patient Global Impression of Improvement (PGI-I)(6 months)
- Behavioral Outcomes(6 months)
- Pelvic Floor Distress Inventory-20 (PFDI-20)(6 months)
- Pelvic Floor Impact Questionnaire-7 (PFIQ-7)(6 months)
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)(6 months)
- Pessary outcomes(6 months)