Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0300143214
Study information
Scientific title
Acronym
Study hypothesis
Whether increasing the hydrostatic pressure of irrigation fluid during flexible cystoscopy makes the procedure more tolerable.
Ethics approval
Not provided at time of registration
Study design
Prospective single blinded randomised controlled trials
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Not Applicable: Service delivery
Intervention
1. Pressure of irrigating fluid is increased at the prostatic urethra
2. No change in pressure of irrigating fluid
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Visual analogue scale
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2004
Overall trial end date
01/11/2004
Reason abandoned
Eligibility
Participant inclusion criteria
128 Royal Blackburn Hospital patients listed for flexible cystoscopy.
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
128
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2004
Recruitment end date
01/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Urology
Blackburn
BB2 3HH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Lancashire Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18554699
Publication citations
-
Results
Gunendran T, Briggs RH, Wemyss-Holden GD, Neilson D, Does increasing hydrostatic pressure ("bag squeeze") during flexible cystoscopy improve patient comfort: a randomized, controlled study., Urology, 2008, 72, 2, 255-8; discussion 258-9, doi: 10.1016/j.urology.2008.02.072.