Pain Level During Male Urethral Catheterisation - Does Patient Attempted Urination During Catheterisation Reduce Pain? A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change from baseline in visual analog pain scales
研究概览
简要总结
Currently, there are no specific guidelines or best practice suggestions for best male catheterization as fat as insertion technique. There is however, information as to reducing infection, and as to recommended lubricant.
From our experience, the investigators have noticed that when requesting the patient to attempt urination while inserting a urethral catheter, the level of pain and discomfort is reduced. In this study, the investigators will evaluate the pain level during male urethral catheterization in each technique.
Our hypothesis is that the level of pain will be much less if the in the study group where the act of urination will be requested from the patient.
详细描述
This is a randomized prospective study that will compare the pain levels of urethral catheterization in men randomized to requesting to urinate while inserting a urethral catheter to normal catheter insertion.
Males aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptoms will be included.
Patients will be randomized to 2 groups: (1) Patients who will be requested to urinate while catheterising the urethra to its full length; (2), Patients who will be requested to lie while catheterising the urethra, without further instructions from the medical professional. In both groups, prior to catheterisation, 10 ml of lidocaine gel will be inserted into the urethra. The randomization technique will be employed by a computerized random number generator.
A 12F Tieman urethral catheter will be introduced in order to measure post-void residual volumes. Subsequently, multichannel Urodynamic testing (Duet Encompass System - Mediwatch Group Plc) will be performed using a dual lumen 6F urethral and 9F rectal catheters. Filling will be carried out using room temperature saline at a filling rate of 50 ml/min.
Patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual analog pain scale (VAS) in different time points: before the procedure (baseline), immediately after gel instillation, immediately after the introduction of the Tieman catheter, 15 minutes after the catheter will be taken out.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptoms.
排除标准
- •use of any analgesics within the previous 24 hours, known urethral stricture, active urinary tract infection, indwelling urethral catheter, pre-existing urethral pain (e.g. patients with chronic pelvic pain syndromes and interstitial cystitis), inability to cooperate with pain assessment due to mental disorders.
结局指标
主要结局
Change from baseline in visual analog pain scales
时间窗: Before catheterisation, during catheterisation, 15 minutes after catheterisation
A 0 to 10 visual analog pain scale (VAS)
次要结局
未报告次要终点
研究者
Assaf Harofeh MC
Dr. Kobi Stav
Assaf-Harofeh Medical Center