Bladder Shaper Test (BlaST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04017000|
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : June 22, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Diagnosis of Urinary Tract Symptons||Diagnostic Test: Bladder Shape Test Other: Calibration images||Not Applicable|
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 basis of a novel diagnostic test for detecting involuntary contractions associated with overactive bladder syndrome and urgency incontinence.
The detection of involuntary bladder contractions currently relies on invasive internal pressure measurement, commonly termed Urodynamics. This is an invasive test involving the placement of pressure measurement catheters, usually via the urethra into the bladder and via the anal canal into the rectum. In its normal healthy state, the bladder remains a contractile throughout filling and is compliant, meaning that there is minimal or zero increase in pressure as it fills. During Urodynamics, the bladder is filled artificially, using a pump, with water or contrast medium via a urethral catheter, whilst abdominal pressure is measured via a rectal catheter introduced anally. Differences between pressure measurements in the bladder and the abdomen are used to detect involuntary detrusor contractions; termed 'detrusor over activity when detected during Urodynamics. Patients often report Urodynamics as being uncomfortable and undignified, and the test carries a risk of introducing urinary tract infection. Furthermore, there are significant issues relating to the sensitivity of Urodynamics in the detection of abnormal bladder contractions in the context of Overactive Bladder.
Variations in bladder shape have been observed in association with detrusor over activity during video-Urodynamics, when fluoroscopic images are captured during filling with contrast medium. At one extreme, women with neuropathic overactive bladder have been observed to have tense, spherical or dome-shaped bladders with trabeculations 'fir tree' or 'Christmas tree' bladder. In women with normal detrusor muscle function, the bladder outline appears relaxed and a contractile, following the contours of the pelvis when assessed by cystography.
Although conventional Urodynamics has previously been regarded as the 'Gold Standard' in the assessment of lower urinary tract disorders, it is also well recognised as having issues of sensitivity, patient acceptability and cost. The test is commonly employed to diagnose and better understand the underlying pathophysiology of incontinence and is often deemed necessary, particularly prior to invasive forms of treatment. The requirement for urodynamic equipment, including its purchase, maintenance, associated training and size restricts its use to specialist hospital facilities, rendering it relatively inaccessible as a diagnostic tool. In addition to this patients have reported finding Urodynamics embarrassing and uncomfortable and with the inclusion of x-ray screening (video-cystometry) which is part of the procedure which aims to contemporaneously evaluate lower urinary tract structure and morphology, involves exposure to ionising radiation and is of unproven benefit. Therefore, there is a patient & clinical need to objectively assess lower urinary tract function with less invasive, sensitive, reproducible and more widely available tests.
A pilot study will now be performed to establish the use of bladder shape testing as a new investigation for the assessment and diagnosis of lower urinary tract disorders. It is anticipated that this pilot will lead to the development of a new healthcare product that can be used in the primary care setting as an alternative to urodynamic assessment in the acute secondary care environment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
Clinician performing patient Urodynamics will be different from the clinician who undertakes the bladder shape test.
Urodynamics clinician will be blinded to the results of the bladder shape test.
|Official Title:||BLAdder Shape Test: Medium-fill Cystometry and Trans-abdominal Assessment of Bladder Shape in Women With Overactive Bladder|
|Actual Study Start Date :||April 2, 2019|
|Actual Primary Completion Date :||January 31, 2022|
|Actual Study Completion Date :||January 31, 2022|
Active Comparator: BlaST study
Patients scheduled for Urodynamic clinic will be offered to participate in the study. Once consented to participate, the participant will be scheduled for a bladder shape test clinic at least one week in advance of their Urodynamic appointment. At their blast clinic, participants will attend a clinical room with a portable bladder scanner. Participants will be asked to consume up to 1000 mls of water over a 20-30 period until their bladder is full. The participant will have their bladder scanned at 10 minute intervals during the filling phase and after prompted voiding.
The participants Urodynamic clinic will run according to routine care.
Diagnostic Test: Bladder Shape Test
Capturing images of bladder under natural filling conditions images are analysed at a later date for shape change.
Calibration Sub Study
Any patients who are not eligible or decline participation in the main study will be offered the chance to participate in the calibration sub study.
Participants will be scheduled for their clinically indicated Urodynamic appointment where they will have their bladder imaged by portable ultrasound.
Participants will consent for these images to be used as part of the calibration of the technology being used to measure bladder shape change.
Other: Calibration images
Capturing images of bladder under artificial filling conditions during Urodynamic assessment images are analysed at a later date to inform shape change technology.
- Recruitment [ Time Frame: At 12 months ]Assessing recruitment rate for a larger study
- Participants Completion Rate [ Time Frame: At 12 months ]Assessing drop out and completing patients to inform sample size for larger study
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Study only available to women attending Urogynaecology clinics|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017000
|Sheffield Teaching Hospitals|
|Sheffield, United Kingdom|
|Principal Investigator:||Stephen Radley||Sheffield Teaching Hospitals NHS Foundation Trust|
|Responsible Party:||Sheffield Teaching Hospitals NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||July 12, 2019 Key Record Dates|
|Last Update Posted:||June 22, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|