Randomised comparison of intermittent urethral and indwelling suprapubic catheterisation in the management of voiding after urogynaecological surgery

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN66645527
• Date of registration: 09/07/2009
• Prospective Registration: No
• Primary sponsor: Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
• Public title: Randomised comparison of intermittent urethral and indwelling suprapubic catheterisation in the management of voiding after urogynaecological surgery
• Scientific title: Intermittent urethral versus indwelling suprapubic catheterisation in the management of voiding after urogynaecological surgery: a randomised single centre controlled trial
• Date of first enrolment: 01/04/2004
• Target sample size: 90
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN66645527
• Study type: Interventional
• Study design: Single centre randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Paul Hilton

Key inclusion & exclusion criteria

Inclusion criteria: All women electively admitted for surgery for urodynamic stress incontinence or pelvic organ prolapse. No age limits.
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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Urodynamic stress incontinence, utero-vaginal prolapse
Urological and Genital Diseases
Other disorders of urinary system

Intervention(s)

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

Primary Outcome(s)

Length of hospital stay, measured from day of admission to day of discharge with a range of between 2 - 19 days.

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded (UK)