A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 725
- 试验地点
- 28
- 主要终点
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure
研究概览
简要总结
- This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
- The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
- The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
- The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure.
- Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair
排除标准
- •The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse.
- •Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
- •Subject has active or latent systemic infection or signs of tissue necrosis.
- •Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis.
- •Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered.
- •Subject has had radiation therapy to the pelvic area.
- •Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
- •Subject has a known hypersensitivity to the graft material(s).
- •Subject has uncontrolled diabetes.
- •Subject is on any medication which could result in compromised immune response, such as immune modulators.
- •Subject was involved in any other research trial < 30 days of enrollment into this study.
- •Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
- •Subject is unwilling or unable to give valid informed consent.
- •Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits.
- •Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
结局指标
主要结局
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure
时间窗: 12-months
Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure
时间窗: 12-months
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure
时间窗: 12-months
Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
次要结局
- Rates of de Novo or Worsening Urinary and/or Anal Incontinence(Through 24 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M(baseline and 24 months)
- Procedural Time(Approximately 30 minutes)
- Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure(baseline and 6 weeks)
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M(baseline and 12 months)
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12(baseline and 24 months)
- Estimated Blood Loss(Approximately 30 minutes)
- Percent of Subjects Experiencing Major Device Related Complications(Through 24 months)
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months(6 months)
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months(24 months)
- Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)(24 months)
- Rate of Graft Extrusions(Through 24 months)
- Surgical Revision Rate(Through 24 months)
- Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)(12 months)
- Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)(24 months)
- Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)(6 months)
- Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)(6 Months)
- Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)(24 months)
- Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)(6 months)
- Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)(12 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M(baseline and 6 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M(baseline and 12 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M(baseline and 24 months)
- Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)(12 months)
- Wong-Baker Faces Pain Scale at 3 Months Post Procedure(baseline and 3 months)
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M(baseline and 6 months)
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M(baseline and 24 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M(baseline and 6 months)
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure(24 months)
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure(6 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M(baseline and 12 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M(baseline and 12 months)
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure(6 months)
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure(24 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M(baseline and 6 months)
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M(baseline and 24 months)