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

ISRCTN	ISRCTN66645527
DOI	https://doi.org/10.1186/ISRCTN66645527
Protocol serial number	N/A
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Funder	Investigator initiated and funded (UK)

Submission date: 28/05/2009
Registration date: 09/07/2009
Last edited: 01/05/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Paul Hilton
Scientific

Directorate of Women's Services
Level 3, Leazes Wing
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Intermittent urethral versus indwelling suprapubic catheterisation in the management of voiding after urogynaecological surgery: a randomised single centre controlled trial
Study objectives	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(s)	Newcastle and N. Tyneside Local Research Ethics Committees approved on the 20th January 2004 (ref: 2003/155)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Length of hospital stay, measured from day of admission to day of discharge with a range of between 2 - 19 days.
Key secondary outcome measure(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
Completion date	01/07/2004

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Female
Target sample size at registration	90
Key inclusion criteria	All women electively admitted for surgery for urodynamic stress incontinence or pelvic organ prolapse. No age limits.
Key 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
Date of first enrolment	01/04/2004
Date of final enrolment	01/07/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Directorate of Women's Services

Newcastle upon Tyne
NE1 4LP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes