Condition category
Urological and Genital Diseases
Date applied
28/05/2009
Date assigned
09/07/2009
Last edited
01/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Paul Hilton

ORCID ID

Contact details

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

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 measures

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

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

http://www.newcastle-hospitals.org.uk/services/index.aspx

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20948487

Publication citations

  1. Results

    Dixon L, Dolan LM, Brown K, Hilton P, RCT of urethral versus suprapubic catheterization., Br J Nurs, 19, 18, S7-13.

Additional files

Editorial Notes