Comparison of Single Versus Multicenter Outcomes for Pelvic Organ Prolapse Repair Using a Mesh-capturing Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 319
- 主要终点
- The rate of immediate complications
研究概览
简要总结
Comparison of single versus multicenter outcomes for pelvic organ prolapse repair using a mesh-capturing device (The Uphold™ Vaginal Support System for apical and vaginal wall prolapse - Boston Scientific). 1-2 years follow up study comprison of 112 vs 207 patients.
详细描述
112 women operated by two surgeons at one center (2 years follow up) are to be compared to 207 women operated by twenty six surgeons at twenty four centers (1 year follow-up).
Screening at baseline for apical (uterine or vaginal vault) prolapse stage II with or without concomitant anterior or vaginal wall prolapse ≥ stage 2 according to the pelvic organ prolapse quantification (POP-Q) system.
Surgical data including operation data, complications and hospital stay are to be compared.
Anatomical outcome measurements by POP-Q evaluations. Subjective symptoms are to be evaluated by prolapse specific symptom questionnaires (PFIQ-7, UDI-6 and PFIQ) whereas sexual function to be estimated by PISQ-12.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Posthysterectomy prolapse of the vaginal apex where the vaginal apex descends less than 50% of the total vaginal length regardless of whether a cystocele is present or not
- •Uterine prolapse, with or without cystocele, where the leading edge of the cervix descends less than 50% of the total vaginal length
- •If cervix elongation is present corresponding to: TVL minus point C= >2 cm.
- •If prolapse specific pelvic symptoms of pelvic heaviness and/or vaginal bulging are not present
- •Previous or current pelvic organ cancer (regardless of treatment)
- •Severe rheumatic disease
- •Insulin treated diabetes mellitus
- •Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Dahnlos, collagenosis, polymyositis eller rheumatic myalgia)
- •Current systemic steroid treatment
- •Other clinically relevant pelvic disorders for which surgery is indicated including stress urinary incontinence, cervix elongation and posterior prolapse
- •Decision to perform prolapse surgery using other medical devices/mesh
结局指标
主要结局
The rate of immediate complications
时间窗: From operation start to hospital discharge, assessed for an estimated total of days (1-7 days).
Serious surgical complications are categorized as any surgical event which is potentially life-threatening related to the surgical procedure including: internal organ perforation (or other injury), bleeding in excess of 1000 mL.
Rate of delayed complications
时间窗: From hospital discharge and up to 2 years at single center and 1 year at multicenter
Adverse events during follow-up which requires re-hospitalisation or surgical re-intervention.
次要结局
- Ultrasound mapping of mesh position in the pelvic floor and correlation to anatomical and subjective outcomes and sexual function(5, 7, 10 years)
- Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale)(Changes from baseline, 2, 5 and 10 years after surgery)
- Measurement of patient satisfaction by patient self-reporting Visual analogue scale (VAS-scale)(assessment at 2, 5 and 10 years after surgery)
- 12. Measurement of patient recommendation to other patients to undergo same surgery with vaginal mesh if they suffer apical prolapse, assessed by patient self-reporting Visual analogue scale (VAS-scale)(assessment at 2, 5 and 10 years after surgery)
- Anatomical outcomes(2 years vs 1 year)
- Subjective outcomes and sexual function(2 years vs 1 year)
- Measurement of urinary incontinence by patient self-reporting Visual analogue scale (VAS-scale)(Changes from baseline, 2, 5 and 10 years after surgery)
研究者
Edward Morcos
Senior consultant, MD, PhD
Karolinska Institutet