Status:
COMPLETED
Bladder Shaper Test
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
Conditions:
Diagnosis of Urinary Tract Symptons
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is comparing a novel method of Bladder shape measurements using ultrasound for diagnosis of lower urinary tract symptoms in comparison to traditional Urodynamic assessment. All participants...
Detailed Description
This study hypothesises that bladder shape changes associated with involuntary contractions of the detrusor muscle, might be detected using trans abdominal ultrasound, which could itself form the basi...
Eligibility Criteria
Inclusion
- Women referred for urodynamic evaluation of LUTS, including urinary storage symptoms, with or without incontinence.
- Women aged 18 years and over.
- Women willing and able to discontinue any current anticholinergic medication for a minimum period of 10 days prior to starting any study-related procedure.
- Women who understand and are willing and feel able to comply with the study protocol/procedures and who have provided written informed consent.
Exclusion
- Current pregnancy
- Suspicion of pelvic malignancy
- Unable to consume 1000ml still water over 20 minutes
- Current urinary tract infection (UTI) (as assessed by urine dipstick and symptomatology. Patients with current UTI will be treated and further BlaST/Urodynamics appointments offered as appropriate. Women with cyclical urinary symptoms in association with menstrual cycle will be scheduled for BlaST and conventional Urodynamics at the same time each month, other patients will receive both tests usually within a month of each other, but never on the same day.
Key Trial Info
Start Date :
April 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04017000
Start Date
April 2 2019
End Date
January 31 2022
Last Update
June 22 2022
Active Locations (1)
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1
Sheffield Teaching Hospitals
Sheffield, United Kingdom