None listed
Conditions
Brief 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.
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
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.
Sponsors
Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male 18 years or older No previous complications during flexible cystoscopies No anticipated additional procedure is to be required during cystoscopy
Exclusion criteria
Chronic pelvic pain Bladder pain syndrome or interstitial cystitis Chronic pain syndrome History of meatal stenosis, urethral stricture or bladder neck contracture Use of analgesia within 24 hours of cystoscopy Presence of indwelling urethral catheter within 24 hours of cystoscopy
Outcome results
None listed