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临床试验/NCT07173517
NCT07173517尚未招募不适用

Cost Profile and Budget Implications of Rechargeable Versus Non-rechargeable Sacral Neuromodulation Devices for Neurogenic Lower Urinary Tract Dysfunction

Qilu Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
268
试验地点
1
主要终点
Costs associated with sacral neuromodulation therapy

研究概览

简要总结

Traditional sacral neuromodulation devices are not rechargeable. In recent years, new rechargeable sacral neuromodulation devices have been developed and put into the market. The aim of this study was to evaluate the cost savings of a rechargeable sacral neuromodulation device versus a non-rechargeable sacral neuromodulation device for the treatment of neurogenic lower urinary tract dysfunction.

详细描述

From August 2020 to January 2025, 41 rechargeable and 227 non-rechargeable SNM patients with neurogenic lower urinary tract dysfunction in ten centers were enrolled in this study. Demographic data, SNM treatment-related costs, and adverse events (e.g., treatment discontinuation, infection, surgical site pain, and lead dislocation or fracture) were recorded for each patient to estimate the costs of long-term SNM treatment with rechargeable versus nonrechargeable devices.

SPSS 25.0 software was used for statistical analysis of the data. Measurement data were expressed as mean ± SD, count data were expressed as cases (%), and paired t test was used for comparison before and after treatment in the group. P < 0.05 was considered statistically significant.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • male and female patients with neurogenic lower urinary tract dysfunction who had failed conventional treatment
  • obstructive urinary retention and contraindications to SNM

排除标准

  • 未提供

结局指标

主要结局

Costs associated with sacral neuromodulation therapy

时间窗: From August 2020 to January 2025

Costs associated with sacral neuromodulation therapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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