Accuracy of Bladder Ultrasound Study (BUS)

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN46820623
• Date of registration: 18/09/2012
• Prospective Registration: No
• Primary sponsor: University of Birmingham (UK)
• Public title: Accuracy of Bladder Ultrasound Study (BUS)
• Scientific title: Accuracy of Bladder Ultrasound in the diagnosis of Detrusor Overactivity (DO): a study to evaluate if ultrasound can reduce the need for urodynamics
• Date of first enrolment: 01/04/2011
• Target sample size: 600
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN46820623
• Study type: Observational
• Study design: Diagnostic (test accuracy) study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Pallavi Latthe

Key inclusion & exclusion criteria

Inclusion criteria: 1. Frequency of 9 or more voids in 24 hours as reported in the 3 day bladder diary at least on one of the days
2. Mild - severe urgency (cannot defer the urge to void) on at least one occasion in 3 day bladder diary
3. Post void residual volume <100 mls on screening
4. Written informed consent
5. If patient has had previous stress incontinence surgery &/or Botox, it was >6 months ago
Exclusion criteria: 1. Pregnancy and up to 6 weeks postpartum
2. Pure symptoms of stress incontinence or stress predominant mixed incontinence
3. Evidence of cystitis (dipstick positive for leucocytes/nitrites)
4. Voiding difficulties (post void residual >100 ml)
5. Prolapse > grade II (any compartment)
6. Urodynamics, assessment in the past 6 months
7. Use of antimuscarinics for more than 6 months continuously.
8. Current use of anti-muscarinics (e.g. Tolterodine, solifenacin, oxybutynin). If the woman is taking anti-muscarinics at the point of consent, she will be eligible if medication is ceased immediately
9. There is a delay of at least 2 weeks until the index and reference tests are carried out.

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive bladder syndrome
Urological and Genital Diseases
Other specified disorders of bladder

Intervention(s)

The bladder wall thickness will be obtained by means of an ultrasound examination. In order to perform this scan it is necessary to gently insert the tip of an ultrasound probe into the vagina. This is a simple and usually painless procedure.

For reference standard, UDS will be performed on all patients for DO verification.

Primary Outcome(s)

The BUS testing procedure will be standardised in the first phase of the study and criteria for interpretation have been determined a priority. The first objective of the study is to determine the accuracy of BUS in the diagnosis of DO. To do this, the comparison of BUS against UDS will be made and estimates of sensitivity, specificity, predictive values, likelihood ratios and their 95% confidence intervals calculated.

Secondary Outcome(s)

To investigate the value added by BUS to information already obtained from routinely used initial non-invasive tests (history, bladder diary, urine dipstick).

Secondary ID(s)

HTA 09/22/122, Version 5.0

Source(s) of Monetary Support

Health Technology Assessment Programme

Secondary Sponsor(s)

Birmingham Women's NHS Foundation Trust (UK)