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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Directorate of Women's Services
Level 3, Leazes Wing
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
Study information
| Study design | Single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2004 |
| Completion date | 01/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Female |
| Target number of participants | Greater than 90 participants |
| 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
- England
- United Kingdom
Study participating centre
Directorate of Women's Services
Newcastle upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/services/index.aspx |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Other
Investigator initiated and funded (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
