NCT01559168已完成不适用
Clinical Evaluation of the Uphold Mesh for the Surgical Treatment of Uterine-predominant Prolapse: a Prospective, Multicenter Trial
Centre Hospitalier Universitaire de Nīmes18 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2012年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 18
- 主要终点
- Anterior vaginal wall anatomical success
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.
详细描述
Secondary objectives include the evaluation of the following:
- Change from baseline of POP-Q scoring at 6 weeks, 6 months and 12 months post procedure, including evolution of treated or non-treated posterior compartments.
- The proportion of patients with anatomical prolapse (C/D), but who are asymptomatic.
- Change from baseline of mean quality-of-life scores.
- Evaluation of mesh properties from procedure date through study period.
- Peri-operative and post-treatment pain score assessment comparing the various anesthesia regimes used (Visual Analog Scale).
- Assessment of patient subjective outcomes for overall treatment effects and satisfaction.
- Objective evaluation of mesh shrinkage by standardized ultrasound measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 12 months of follow-up
- •Patients with symptoms and altered quality of life in relation to uterine or post-hysterectomy vault prolapse
- •Patients who are receiving the UpholdTM LITE mesh Kit
- •Female patients >= years who have no desire of future pregnancy
- •Diagnosed with pelvic organ prolapse and >= ICS POP-Q Stage 2 Symptomatic Prolapse apical compartment (uterine or vault), associated with ICS POP-Q Stage 2 or 3 Symptomatic Prolapse anterior compartment (point Ba >= -1
- •Patients willing to complete quality of life questionnaire at baseline (pre-procedure) and at 6 weeks, 6 and 12 months post-procedure
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •Patients who are not receiving the UpHoldTM LITE mesh Kit
- •Patients < 50 years
- •Patients qho, according to the clinical judgment of the investigator, are not suitable for this study
- •Patients who are considering future pregnancies
- •Patients whose pelvic organ prolapse is a <= 1 ICS Stage
- •Patients requiring Posterior Graft procedure
- •Patients with known or suspected hypersensitivity to polypropylene
- •Patients with any pathology which ould compromise implant placement
- •Patients with any pathology which ould compromise implant placement as mentioned in the device instruction manual
- •Patients with any pathology that would limit blood supply and compromise healing
- •Patients with blood coagulation disorder (associated current level coagulation)
- •Patients with autoimmune connective tissue disease
- •Patients with upper urinary tract obstruction and renal insufficiency
- •Patients with local or systemic infection
研究组 & 干预措施
Prolapse patients recieving UpHold LITE
Experimental
Non-pregnant female patients >= 50 years who are not considering future pregnancies, who are diagnosed with uterine or vault prolapse with ICS POP-Q score of stage 2 or greater, who are receiving the UpholdTM LITE mesh kit and who agree to be in the study.
干预措施: UpholdTM LITE placement (Device)
结局指标
主要结局
Anterior vaginal wall anatomical success
时间窗: 12 months
Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba \< = stage 1 per POP-Q scoring (ICS)
Change from baseline in PFDI-20 scores
时间窗: baseline to 12 lines
Apical anatomical success
时间窗: 12 months
Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C \<= stage 1 per POP-Q scoreing (ICS)
次要结局
- Change from baseline in PFDI-20 scores(baseline to 6 months)
- Number of days necessary for return to normal activities(6 weeks)
- Change from baseline in PFIQ-7 scores(baseline to 12 months)
- length of hospital stay (days)(6 weeks)
- Mesh contraction (cm)(12 months)
- Patient satisfaction (PGI index) score(12 months)
- Change from baseline in PISQ-12 scores(baseline to 12 months)
- Anterior vaginal wall anatomical success(6 weeks)
- Apical anatomical success(6 months)
- Visual analog scale for post-operative pain(12 months)
- Mesh related morbidity(12 months)
- Change from baseline in PFIQ-7 scores(baseline to 6 months)
- Change from baseline in PISQ-12 scores(baseline to 6 months)
- Anterior vaginal wall anatomical success(6 months)
- Apical anatomical success(6 weeks)
- Change from baseline in PFDI-20 scores(baseline to 6 weeks)
- Change from baseline in PFIQ-7 scores(baseline to 6 weeks)
- Visual analog scale for post-operative pain(Day 1)
- Visual analog scale for post-operative pain(6 weeks)
- Visual analog scale for post-operative pain(6 months)
- Mesh related morbidity(Day 1)
- Mesh related morbidity(6 weeks)
- Mesh related morbidity(6 months)
- Mesh contraction (cm)(6 weeks)
- Mesh contraction (cm)(6 months)
- Patient satisfaction (PGI index) score(6 weeks)
- Patient satisfaction (PGI index) score(6 months)
研究者
研究点 (18)
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