Accuracy of Bladder Ultrasound Study (BUS)

Accuracy of Bladder Ultrasound in the diagnosis of Detrusor Overactivity (DO): a study to evaluate if ultrasound can reduce the need for urodynamics

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN46820623

Enrollment

600

Registered

2012-09-18

Start date

2011-04-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 i

Eligibility

Sex/Gender

Female

Inclusion 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 6 months ago

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026