Accuracy of Bladder Ultrasound Study (BUS)

Not Applicable

Completed

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

Registration Number: ISRCTN46820623

Lead Sponsor: niversity of Birmingham (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 600

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

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