NCT06296316终止不适用
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair: an Observational Post-Market Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up
研究概览
简要总结
The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery.
详细描述
This study is a non-interventional, multicenter and post market clinical follow-up in adult women with apical prolapse under normal conditions of use (after a sacrocolpopexy with Restorelle mesh for apical prolapse repair as part of routine care). The patient will be followed for 1 year (or less) by the investigator as per local usual practice. At the same time, the patient will be followed via PRO (Patient Reported Outcomes) over a period of 5 to 8 years.
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
- •Female patient of at least 18 years old
- •Patient presenting apical pelvic organ prolapse and being eligible to surgical treatment
- •Surgeon having decided to treat the patient with a Restorelle mesh as per its CE mark indication and IFU, before patient inclusion
- •Patient having received appropriate information and counselling before mesh implantation
- •Patient has been provided written informed consent
排除标准
- •Patient currently pregnant or breastfeeding
- •Patient being deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection
结局指标
主要结局
The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up
时间窗: up to 5 years
次要结局
- Number of patients who have only had surgical reintervention not related to Restorelle mesh use(through study completion, at least 5 and up to 8 years)
- Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use)(5 years ; up to 8-year after index procedure)
- Number of Restorelle mesh Device Deficiencies(through study completion, at least 5 and up to 8 years)
- Incidence rate of surgical reintervention related to Restorelle mesh use in patients(through study completion, at least 5 and up to 8 years)
- Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use)(5 years ; up to 8-year after index procedure)
- Description of Restorelle mesh Device Deficiencies(through study completion, at least 5 and up to 8 years)
- Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire(through study completion, at least 5 and up to 8 years)
- Changes of prolapse symptoms(Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years))
- Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention(6 months after surgical reintervention)
- Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active.(Pre-index procedure ; 12 months)
- Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use(through study completion, at least 5 and up to 8 years)
- Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use)(5 years ; up to 8-year after index procedure)
- Percentage of Adverse Device Effect(through study completion, at least 5 and up to 8 years)
- Percentage of Restorelle mesh Device Deficiencies(through study completion, at least 5 and up to 8 years)
- Prolapse symptoms - number(12 months ; 5 years)
- Number of patients defining success via patient global impression of improvement (PGI-I) scale(2 months ; 12 months ; Every year (at least 5 and up to 8 years))
- Number of Adverse Device Effect(through study completion, at least 5 and up to 8 years)
- Prolapse symptoms - percentage(12 months ; 5 years)
- Assessment of health related quality of life using the EQ-5D-5L questionnaire(Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years))
- Assessment of health related quality of life using the PFIQ-7 questionnaire(Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years))
- Assessment of the sexual functioning by the PISQ-IR questionnaire(Pre-index procedure ; 2 months ; 12 months ; Every year (at least 5 and up to 8 years))
- Percentage of patients defining success via patient global impression of improvement (PGI-I) scale(2 months ;12 months ; Every year (at least 5 and up to 8 years))
- Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8)(2 months ; 12 months ; Every year (at least 5 and up to 8 years))
- Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8).(2 months ; 12 months ; Every year (at least 5 and up to 8 years))
研究者
研究点 (6)
Loading locations...
相似试验
已完成
不适用
Restorelle® Mesh Versus Native Tissue Repair for ProlapsePelvic Organ ProlapseNCT02162615Coloplast A/S810
招募中
不适用
Role of Mesh in Laparoscopic Sacropexy Surgical Techniques for the Treatment of Female Genital ProlapseFemale Genital ProlapseNCT06720831IRCCS Azienda Ospedaliero-Universitaria di Bologna160
已完成
2 期
Efficacy and Safety of Reduced Pelvic Floor Mesh ImplantsPost Operative PainComplication of Surgical ProcedureNCT01739374Western Galilee Hospital-Nahariya100
已完成
不适用
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market StudyPelvic Organ Prolapse (POP)NCT01378065Coloplast A/S31
Unknown
2 期
Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary DiversionIleal ConduitParastomal HerniaNCT02387333Mansoura University40