Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Number of patients after onabotulinum a toxin injections who respond to treatment
研究概览
简要总结
Purpose: To evaluate urodynamic parameters predicting the treatment efficacy of onabotulinumtoxin A (onaBoNT-A) in patients with neurogenic lower urinary tract dysfunction (NLUTD).
Methods: Patients with NLUTD who received 200 IU onaBont-A injections at Gaziantep University, Faculty of Medicine, Department of Urology between September 2013 and September 2023 were included in the study. Urodynamic parameters, including cystometric capacity, detrusor pressure (Pdet), and compliance, detrusor leak point pressure (DLPP), phasic or terminal neurogenic overactivity were assessed. Additionally, the correlations between these parameters and treatment outcomes were analyzed.
Changes in the number of pads used per day due to UI were assessed every 3 months during the postoperative period. The time lapsed to return to the pad usage levels before onaBoNT-A injections was recorded as the duration of the benefit.
Preoperative urodynamic data of the patients were compared between groups. Additionally, a subgroup analysis was conducted in patients who benefited from treatment to evaluate the correlation between treatment efficacy, duration of benefit from treatment, and urodynamic parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients with Neurogenic Lower Urinary Tract Disorder
- •Aged >18 years
- •Patients who did not respond adequatel to antimuscarinics or could not tolerate their side effects
- •Antimuscarinic treatment failure with at least two different antimuscarinic agents for a minimum of 3 months.
排除标准
- •Patients with Lower Urinary Tract Disorder due to functional or non-neurogenic etiologies
- •Patients who received onaBoNT-A doses either other than 200 IU or its multiple doses
- •In the 12-month period designated for patient follow-up, patients who did not attend their check-ups
研究组 & 干预措施
Botulinum Toxin A responder
Patients who respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 1
干预措施: Botox 200 UNT Injection (Drug)
Botulinum Toxin A non-responder
Patients who did not respond to the 200 IU Onabotulinum toxin-A injections were allocated to Groups 2
干预措施: Botox 200 UNT Injection (Drug)
结局指标
主要结局
Number of patients after onabotulinum a toxin injections who respond to treatment
时间窗: received 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.
次要结局
- treatment succes duration of patients(Received 200 IU of onaBoNT-A injections for the first time, and followed up regularly for the duration of at least 12 months.)
研究者
Muharrem Baturu
Assistant Proffesor
University of Gaziantep