RecruitingACTRN12623000799651

The role of pressure on fluid irrigation on pain during flexible cystoscopy

The role of pressure on fluid irrigation on pain during flexible cystoscopy in men - a randomised, double-blinded controlled trial

Sponsor

Westmead Hospital

Enrollment

190 participants

Start Date

Aug 28, 2023

Study Type

Interventional

Conditions

Pain during cystoscopy

Summary

This research project is testing the effectiveness of using pressurised fluid during flexible cystoscopy insertion in reducing pain. We know that the most significant pain is experienced during camera insertion. There is some evidence that a ‘bag squeeze’, which temporarily generates an increase in fluid pressure that can reduce a participant’s pain, it is unclear how much pressure during the ‘squeeze’ is ideal and it is not easily reproducible. Hence, we also will use pressurised fluid bags with a standardised pressure level to make this more reproducible for participants. Whilst fluid-pressure bags are commonly utilised other areas of Urology such as ureteroscopy, it would represent an experimental intervention for pain-reduction in Flexible Cystoscopy.

Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Flexible cystoscopy is a procedure where a thin, flexible camera is passed through the urethra into the bladder to check for conditions such as bladder cancer, stones, or unexplained bleeding. While generally well-tolerated, many men find the insertion of the camera uncomfortable or painful. This study is investigating whether using pressurised irrigation fluid during camera insertion can reduce pain, making the procedure more comfortable. Participants will be randomly assigned to undergo cystoscopy with either standard fluid irrigation or with the irrigation fluid delivered at a controlled, higher pressure. Pain scores will be measured during and after the procedure. The goal is to find a reproducible, standardised technique that reliably reduces discomfort without increasing complication risks. You may be eligible if you are a man aged 18 or older who is scheduled for a flexible cystoscopy, have not had complications during previous cystoscopies, and do not have chronic pelvic pain, bladder pain syndrome, or a history of urethral stricture. Men who have taken pain medication within 24 hours of the procedure or have had a urinary catheter recently are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Routine flexible cystoscopies will be performed in Westmead Public Hospital’s Endoscopy unit. All participants will be in the supine position and receive 10mL of Instillagel (lidocaine 2% gel) immediately prior to their flexible cystoscopy insertion. Intraurethral lidocaine gel will remain within the participant’s urethra for 1 minute prior to insertion of the cystoscope to allow for standardisation. There will be two intervention arms, that of pressure-bag irrigation and bag-squeeze irrigation. All other equipment will be standardised, including heights of irrigation bags (60cm above the participant’s bladder), the amount and dwell time of Lignocaine impregnated lubricant (10mL, 1 minute) and type of flexible cystoscope (16fr Olympus) will be standardised. These different pressure levels will be used for the duration of the cystoscopy which is estimated to take less than 5 minutes. Procedures will be done by Urology Registrar or Consultant. The intervention arm 1 will be fluid irrigation utilising a standardised pressure bag set at 350mmHg based on flow measurements to achieve same pressure as manual bag squeeze. Intervention arm 2 will be fluid irrigation using ‘bag-squeeze’ method. This occurs by a staff member squeezing the fluid bag during the cystoscopy to increase the fluid rate.

Locations(1)

Westmead Hospital - Westmead

NSW, Australia

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ACTRN12623000799651