AMS AdVance and AdVance XP Male Sling Systems for the Treatment of Stress Urinary Incontinence Following Prostatectomy: Evaluation of Safety, Efficacy, and Quality of Life Through Retrospective Chart Review and Prospective Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
研究概览
简要总结
A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling.
详细描述
A single-center retrospective chart review of AdVance and AdVance XP subject data, combined with prospective follow-up of the same subjects to confirm continence, adverse event, and quality of life status. This study includes patients previously implanted with an AdVance or AdVance XP male sling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Valid, written informed consent has been obtained
- •Male subject ≥40 years of age who received the AdVance male sling after January 1, 2010 or the AdVance XP male sling after July 1, 2010 for the treatment of post prostatectomy SUI
- •Pad use of 1 to 8 pads per day prior to sling placement (subjects who used only a dry prophylactic pad or safety liner at baseline will not be included)
- •External (distal) sphincter contractility and a coaptive zone of ≥ 1cm confirmed by endoscopic view prior to sling placement
- •Primary etiology of SUI resulting from radical prostatectomy including, simple open prostatectomy, robotic or laparoscopic prostatectomy
排除标准
- •Pad use of more than 8 pads per day prior to sling placement for incontinence management
- •Urine loss while lying in bed prior to sling placement
- •Treatment with a urethral sling system, an AMS Sphincter 800®, or any implanted device for the treatment of urinary incontinence (not including bulking agents) prior to sling placement
- •TURP procedure prior to sling placement
- •Urge predominant incontinence prior to sling placement
- •Past or current neurological disorder (e.g. neurogenic bladder, multiple sclerosis, Parkinson's disease)
- •History of connective tissue or autoimmune conditions
- •Past or current condition of compromised immune system
- •Placement of an inflatable penile prosthesis (IPP) after sling placement
- •Post void residual of >50 ml prior to sling placement
结局指标
主要结局
Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use
时间窗: Prospective follow-up to 36 Months Post Procedure
Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit: 0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);
Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use
时间窗: Prospective follow-up to 36 Months Post Procedure
Evaluate the proportion of subjects with a ≥50% reduction in pads per day use
Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use
时间窗: Prospective follow-up to 36 Months Post Procedure
Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit
Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.
时间窗: Baseline to Prospective Follow Up (up to 36 months)
The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100. The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21. The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7.
Number of Adverse Events Reported Between Arms
时间窗: Prospective follow-up to 36 Months Post Procedure
Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events
Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit
时间窗: Prospective follow-up to 36 Months Post Procedure
Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.
次要结局
未报告次要终点