A pilot study evaluating trans-abdominal ultrasound bladder shape test
Research type
Research Study
Full title
A pilot study evaluating trans-abdominal ultrasound bladder shape testing (BlaST) in the assessment of lower urinary tract disorders in women
IRAS ID
256621
Contact name
Stephen Radley
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The two main causes of incontinence in women are sphincter weakness (associated with stress incontinence; leakage on coughing, sneezing or exertion), and involuntary bladder contractions (associated with overactive bladder; urgency, urgency incontinence, daytime frequency, disturbed sleep and bed-wetting). Accurate diagnosis involves detection of abnormal, involuntary bladder contractions in order to understand underlying cause of incontinence. Currently this relies on invasive pressure measurement, commonly termed ‘urodynamics’. This test involves placement of catheters into the bladder and rectum. Patients often report urodynamic testing as being uncomfortable and undignified, the test carries a risk of urinary tract infection and is relatively unreliable and insensitive. Less invasive alternatives are therefore highly desirable.
Our previous feasibility study at Sheffield Teaching Hospitals involved healthy female volunteers and symptomatic patients, using transabdominal ultrasound to assess bladder shape changes during bladder contractions as a potential alternative to urodynamics. This work has provided significant insight into bladder shape testing (BlaST) using trans-abdominal ultrasound, both whilst conducting urodynamics as well as during natural bladder filling.
The research question being addressed in this pilot study is whether transabdominal ultrasound scan, assessing and measuring bladder shape, offers a feasible alternative to urodynamics in patients with lower urinary tract symptoms. This will lay the foundations for larger, multicentre studies in this context.
Over 10 months, women with lower urinary tract symptoms who are being scheduled for urodynamic testing will be eligible to participate in this study, which will be undertaken at Sheffield Teaching Hospitals.
Patients recruited will undergo bladder shape testing (BlaST), using transabdominal ultrasound to assess and measure bladder contractions as their bladder fills naturally over a period of up to 2 hours following consumption of water. They will subsequently have the standard investigation of urodynamics, allowing for comparison of the findings of the two investigations.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0002
Date of REC Opinion
1 Mar 2019
REC opinion
Further Information Favourable Opinion