Armany David, Dhar Ankur, Canagasingham Ashan, Kim Lawrence H C, Wang Audrey
Department of Urology, Westmead Hospital, Corner Hawkesbury & Darcy Roads, Westmead , Sydney, 2145 NSW, Australia.
Speciality of Surgery, University of Sydney, Sydney, Australia.
BMC Urol. 2025 Apr 26;25(1):105. doi: 10.1186/s12894-025-01753-3.
Flexible cystoscopy is widely used for the diagnosis and surveillance of various urological conditions and is commonly performed in an outpatient setting under local anaesthesia. Various adjuncts have been proposed to reduce patient discomfort, with the most notable being the manual bag squeeze method. This approach elevates irrigation fluid pressure, induces hydrodistension, and has received a strong recommendation from the European Association of Urology (EAU). However, the manual bag squeeze method is limited by inconsistencies in the pressure applied by individuals and the need for additional staff members to perform the procedure. This trial aims to assess the efficacy of standardised pressure bags in elevating irrigation fluid pressure during flexible cystoscopy and its impact on reducing mean pain scores, compared to conventional gravity drainage and the manual bag squeeze manoeuvre.
A randomised, controlled, double blinded, single-centre, parallel-group trial will be conducted. Participants scheduled to undergo flexible cystoscopy will be recruited, screened for eligibility and randomised to one of three study groups: (1) Intervention 1 - Pressure bag Group, (2) Intervention 2 - Manual bag squeeze group, and (3) Control - Gravity drainage group with a simulated bag squeeze. Randomisation will be stratified based on participants' history of prior flexible cystoscopy. The primary outcome is the mean pains score reported by participants immediately after the procedure, assessed using a Numerical Rating Scale (NRS). Secondary outcomes include Patient Reported Outcome Measures (PROMIS) surveys at day 7 post flexible cystoscopy to evaluate for pain intensity (1a), Pain inference (short form 6a) and emotional distress-anxiety (Short form 4a), as well as the incidence of complications reported at day 30 post-procedure.
This trial will evaluate the role of pressure bags to elevated fluid irrigation pressure and its effect on reducing patient discomfort during flexible cystoscopy using a rigorous methodology. If proven to be effective, pressure bag fluid irrigation has the potential to be implemented as one of the standards of practice for flexible cystoscopies.
Australian New Zealand Clinical Trials Registry (ANZCTR). Prospective Registration Number: ACTRN12623000799651. Date of Registration 26/07/2023.
软性膀胱镜检查广泛应用于各种泌尿系统疾病的诊断和监测，通常在门诊局部麻醉下进行。人们提出了各种辅助方法来减轻患者的不适，其中最显著的是手动挤压袋法。这种方法可提高冲洗液压力，诱发膀胱扩张，并且得到了欧洲泌尿外科学会（EAU）的强烈推荐。然而，手动挤压袋法存在个体施加压力不一致以及需要额外工作人员进行操作的局限性。本试验旨在评估标准化压力袋在软性膀胱镜检查过程中提高冲洗液压力的效果，以及与传统重力引流和手动挤压袋操作相比，其对降低平均疼痛评分的影响。
将进行一项随机、对照、双盲、单中心、平行组试验。招募计划接受软性膀胱镜检查的参与者，进行资格筛选并随机分为三个研究组之一：（1）干预1 - 压力袋组，（2）干预2 - 手动挤压袋组，（3）对照组 - 模拟挤压袋的重力引流组。随机分组将根据参与者既往软性膀胱镜检查史进行分层。主要结局是参与者在手术后立即报告的平均疼痛评分，使用数字评分量表（NRS）进行评估。次要结局包括在软性膀胱镜检查后第7天进行的患者报告结局测量（PROMIS）调查，以评估疼痛强度（1a）、疼痛干扰（简表6a）和情绪困扰 - 焦虑（简表4a），以及术后第30天报告的并发症发生率。
本试验将使用严谨的方法评估压力袋在提高软性膀胱镜检查过程中液体冲洗压力的作用及其对减轻患者不适的效果。如果被证明有效，压力袋液体冲洗有可能作为软性膀胱镜检查的标准操作之一实施。
澳大利亚新西兰临床试验注册中心（ANZCTR）。前瞻性注册号：ACTRN12623000799651。注册日期：2023年7月26日。
