NCT01378065已完成不适用
Restorelle Direct Fix A&P for Female Pelvic Organ Prolapse: A Prospective Post Market Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)
研究概览
简要总结
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult female at least 18 years of age
- •Willing and able to provide written informed consent
- •Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as determined by Pelvic Organ Prolapse Quantification System (POP-Q) requiring surgical intervention in the anterior and/or posterior compartment
- •Willing and able to complete all follow-up visits and procedures indicated in the protocol
排除标准
- •Concurrent surgical treatment of pelvic organ prolapse using anything other than the Restorelle Direct Fix A&P
- •Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is not being repaired in the same procedure
- •Previous pelvic organ prolapse repair using synthetic grafts
- •Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of vaginal reconstruction
- •Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty) at the time of vaginal reconstruction
- •Pregnant or a desire to become pregnant
- •Previous radiation or other treatments for cancer in the pelvic area
- •Immunosuppression and/or current systemic steroid user
- •On any anticoagulation therapy at the time of implant or with bleeding diathesis
结局指标
主要结局
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)
时间窗: Baseline
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
Palpability of the Restorelle Direct Fix A&P
时间窗: 12 months
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
次要结局
- Rates of de Novo Dyspareunia(12 months)
- Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months(6 months)
- Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks(6 weeks)
- Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months(3 months)
- Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months.(12 months)
- Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit(6 week)
- Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months(12 months)
- Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit(3 month)
- Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit(6 month)
- Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks.(6 weeks)
- Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months.(6 months)
- Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months(Baseline and 3 months)
- Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit(12 month)
- Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months.(12 months)
- Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks(Baseline and 6 weeks)
- Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months.(3 months)
- Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months(Baseline and 6 months)
- Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months(Baseline and 12 months)
- Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months(Baseline and 6 months)
- Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit(Baseline and 6 weeks)
- Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks(Baseline and 6 weeks)
- Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months(Baseline and 3 months)
- Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months(Baseline and 12 months)
- Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit(Baseline and 3 months)
- Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit(Baseline and 6 months)
- Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit(Baseline and 12 months)
研究者
研究点 (6)
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