Bladder Overactivity and Post-Botulinum Toxin Telemonitoring: a Randomized, Controlled, Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 主要终点
- To compare the feasibility of home follow-up in patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up
研究概览
简要总结
Prospective, randomized, controlled, single-center study to compare the feasibility of home monitoring for patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up.
详细描述
Overactive bladder (OAB) affects seventeen percent of the French population and is characterized by a sudden urge to urinate, urinary frequency, with or without incontinence.
Botulinum toxin, injected into the bladder every 6 to 12 months, is an effective treatment. In 2022, more than 10,000 injections were performed in France (ATIH data). At the Grenoble University Hospital (CHUGA), 190 injections were recorded in 2018 and 300 in 2023. As elsewhere, the active patient cohort is increasing exponentially.
Treatment efficacy is assessed using a voiding diary (VD): a three-day record of each voiding episode with bladder capacity, frequency, and leakage. It is essential to detect the onset of voiding dysfunction through uroflowmetry and ultrasound measurement of post-void residual (PVR) at 6 weeks after injection (peak diffusion and efficacy). This allows determining the dose and frequency of reinjections. The goal is to improve quality of life, but also to protect the upper urinary tract, particularly in neurogenic bladders.
These 300 annual injections require 300 follow-up consultations, but many data points are often missing. Indeed, patients currently often attend post-injection consultations without a voiding diary and with a non-empty bladder… It is therefore important to improve this follow-up.
With our VESIC@HOME project, we aim to provide patients with the services of the home-care provider IC@dom and, thanks to suitable connected tools (Homeflow®), collect VD and uroflowmetry/PVR at home, as well as quality-of-life questionnaires, thereby improving data completeness under more physiological and comfortable conditions for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a neurogenic bladder or idiopathic overactive bladder.
- •Patient treated with intradetrusor botulinum toxin injection as part of their usual care, whether performing spontaneous voiding or self-catheterization.
- •Patient whose residence allows a home visit by a service provider within the area covered by the AGIR à dom group.
- •Patient affiliated with the social security system.
- •Patient willing to provide informed consent
排除标准
- •Persons covered under Articles L1121-5 to L1121-8 of the French Public Health Code (CSP), corresponding to all protected persons: pregnant or postpartum women, breastfeeding mothers, individuals deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, individuals admitted to a healthcare or social facility for purposes other than research, minors, persons under legal protection, or individuals unable to give consent.
- •Staff members with a hierarchical relationship with the principal investigator.
研究组 & 干预措施
hospital based follow-up
The patient must arrive with a full bladder (a minimum volume of 150 mL, including both the voided volume and the post-void residual), refrain from voiding until urinating into the uroflowmeter, have completed their bladder diary at home beforehand (measuring with a graduated container over 3 days and 3 nights), have filled out the EQ-5D-5L (quality of life), USP (urinary symptoms), and PGI (post-treatment global impression of improvement) questionnaires, and bring them along
home based follow-up group
A nurse from the provider will bring the equipment required for the different measurements (Homeflow®) and explain its use to the patient. The nurse will also give the patient the EQ-5D-5L (quality of life), USP (urinary symptoms), and PGI (post-treatment global impression of improvement) questionnaires in paper format. A first assessment of the PVR may already be performed. The nurse will return to collect the equipment and questionnaires and to perform a PVR measurement 72 hours later. The recorded data are transmitted directly to the physician, who can view them on their computer (a dedicated secure application provided with the Homeflow solution) and export them in PDF format to add them to the patient's file."
干预措施: home care (Other)
结局指标
主要结局
To compare the feasibility of home follow-up in patients receiving intradetrusor botulinum toxin injections with that of the usual hospital-based follow-up
时间窗: at 8 weeks
Rate of completeness of data collected at home compared with data collected in the hospital setting. To be considered complete, the data must include: The 3-day/3-night bladder diary (including the time and volume of each void); a diary is considered complete even if 3 measurements over the 72-hour period are missing (this accounts for possible patient appointments). The urinary symptom questionnaire (Urinary Symptom Profile, USP); Uroflowmetry and post-void residual measurements (only for patients who do not perform intermittent self-catheterization). All of these data are necessary to address the objective. We cannot separate them, as they serve the same objective.
次要结局
- Compare urinary symptoms according to the type of follow-up.(at 8 weeks)
- Compare functional outcomes ( Normal bladder emptying with not significant post-void residual) according to the type of follow-up in patients with spontaneous voiding.(at 8 weeks)
- Compare complications according to the type of follow-up.(at 8 weeks)
- Compare overall quality of life according to the type of follow-up.(at 8 weeks)