Bladder Shaper Test

NCT ID: NCT04017000

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2022-01-31

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 will undergo the novel investigation followed by their usual Urodynamics.

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 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.

Conditions

Diagnosis of Urinary Tract Symptons

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bladder Shape Test

Intervention Type: DIAGNOSTIC_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.

Group Type: OTHER

Calibration images

Intervention Type: OTHER

Capturing images of bladder under artificial filling conditions during Urodynamic assessment images are analysed at a later date to inform shape change technology.

Interventions

Bladder Shape Test

Capturing images of bladder under natural filling conditions images are analysed at a later date for shape change.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sheffield

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Radley

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Sheffield Teaching Hospitals

Sheffield, , United Kingdom

Countries

United Kingdom

Other Identifiers

STH20318

Identifier Type: -

Identifier Source: org_study_id