Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Intermittent urethral versus indwelling suprapubic catheterisation in the management of voiding after urogynaecological surgery: a randomised single centre controlled trial
Acronym
Study hypothesis
The aim of this study was to investigate the hypothesis that intermittent catheterisation (IC) is associated with a more rapid return to normal micturition following urogynaecological surgery by undertaking a randomised comparison of IC with suprapubic catheterisation in women undergoing surgery for urodynamic stress incontinence or utero-vaginal prolapse.
Ethics approval
Newcastle and N. Tyneside Local Research Ethics Committees approved on the 20th January 2004 (ref: 2003/155)
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Urodynamic stress incontinence, utero-vaginal prolapse
Intervention
All women electively admitted for surgery for urodynamic stress incontinence or pelvic organ prolapse were approached with a view to randomisation. A trial information leaflet was provided and those agreeing to participate completed a trial consent form in addition to their surgical consent. They were randomised into one of two groups using opaque sealed envelopes, opened prior to surgery by the consenting surgeon. No blinding of patient, surgeon, nurses nor outcomes assessor was feasible. The two randomisation groups were as follow:
Group 1: bladder drainage by a suprapubic catheter inserted in theatre. The catheter was left on free drainage for 48 hours post-operatively before commencing clamping
Group 2: catheterised intermittently post-operatively
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Length of hospital stay, measured from day of admission to day of discharge with a range of between 2 - 19 days.
Secondary outcome measures
1. The time to resume normal voiding (defined as voided volumes greater than 200 ml and post-void residual volumes consistently less than 100 ml), recorded within the time of the hospital stay
2. The number of episodes of urinary tract infection (UTI) (defined by catheter-specimen urine [CSU] or mid-stream urine [MSU] showing a single bacterium growing at a colony count greater than 100,000 colony forming units per ml), recorded within the time of the hospital stay
3. Patient experience of catheterisation as determined from a questionnaire given to patients at the end of their hospital stay, recorded within the time of the hospital stay, prior to discharge
Overall trial start date
01/04/2004
Overall trial end date
01/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All women electively admitted for surgery for urodynamic stress incontinence or pelvic organ prolapse. No age limits.
Participant type
Patient
Age group
Other
Gender
Female
Target number of participants
Greater than 90 participants
Participant exclusion criteria
1. Women undergoing surgery where post-operative catheterisation is not routinely employed
2. Women requiring continuous post-operative bladder drainage, e.g. following repair of vesico-vaginal fistula, urethral diverticulectomy, augmentation cystoplasty and operative bladder injury
Recruitment start date
01/04/2004
Recruitment end date
01/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Directorate of Women's Services
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (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
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20948487
Publication citations
-
Results
Dixon L, Dolan LM, Brown K, Hilton P, RCT of urethral versus suprapubic catheterization., Br J Nurs, 19, 18, S7-13.