None listed
Conditions
Brief summary
This study will compare a simple bladder test called single-channel cystometry with the standard multi-channel cystometry test used in urodynamic testing. Urodynamic testing is performed in women with bladder symptoms such as urgency, urinary leakage, difficulty emptying the bladder, or before some prolapse or continence operations. The standard multi-channel test measures pressures in both the bladder and abdomen. Single-channel cystometry is a simpler test that uses a single bladder catheter and sterile fluid to observe bladder filling, bladder sensations, bladder overactivity, and leakage with coughing. Women who are already having clinically indicated urodynamic testing will be invited to participate. All participants will have their usual multi-channel cystometry first as part of standard care. They will then have the additional single-channel cystometry test during the same appointment. The single-channel test is performed for research purposes only and will not be used to determine diagnosis or treatment. The main purpose of the study is to assess how accurately single-channel cystometry identifies detrusor overactivity, or bladder overactivity, and urodynamic stress incontinence, or leakage with increased abdominal pressure, compared with standard multi-channel cystometry. The study hypothesis is that single-channel cystometry will show acceptable diagnostic accuracy and agreement with multi-channel cystometry for detecting detrusor overactivity and urodynamic stress incontinence.
Interventions
What is the intervention: single-channel cystometry, performed as an additional diagnostic test after completion of clinically indicated standard multi-channel cystometry. Single-channel cystometry involves bladder filling with measurement of intravesical pressure only, without a separate abdominal/rectal pressure channel. It is used as the index test in this diagnostic accuracy study and will be compared with standard multi-channel cystometry, which is the reference standard.
Who delivers and
What is the intervention: single-channel cystometry, performed as an additional diagnostic test after completion of clinically indicated standard multi-channel cystometry. Single-channel cystometry involves bladder filling with measurement of intravesical pressure only, without a separate abdominal/rectal pressure channel. It is used as the index test in this diagnostic accuracy study and will be compared with standard multi-channel cystometry, which is the reference standard. Who delivers and their relevant expertise + how is it delivered: The procedure is delivered face to face, individually, during the participant’s routine urodynamic testing appointment at the participating clinical site. It is performed by urogynaecologists and gynaecologists along with urodynamics nursing staff who are trained and experienced in performing urodynamic testing in women with lower urinary tract symptoms. How often, how long, where: Single-channel cystometry is performed once only for each participant, immediately after the standard multi-channel cystometry during the same appointment. The additional research procedure is expected to take approximately 5 minutes. It is conducted in the urodynamics clinic/procedure room using the same clinical environment and infection-control procedures as routine urodynamic testing. Adherence: As this is a one-off diagnostic procedure performed during an attended clinic appointment, participant adherence strategies are not required. .
Sponsors
Dr Hnin Yee Kyaw, Griffith University School of Medicine / Gold Coast University Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult women aged 18 years or older referred for clinically indicated urodynamic testing in urogynaecology or urology practice. Indications for urodynamic assessment may include stress urinary incontinence, urgency urinary incontinence or overactive bladder symptoms, mixed urinary incontinence, voiding dysfunction, pre-operative assessment before pelvic organ prolapse or continence surgery, or post-sling assessment. Participants must be able and willing to provide written informed consent, able to tolerate standard urodynamic catheterisation and bladder filling procedures, and able to communicate bladder sensations and comply with study instructions, either in English or with interpreter assistance if required.
Exclusion criteria
Active urinary tract infection at the time of testing. Pregnancy. Inability to tolerate urodynamic catheterisation or sequential bladder filling. Inability to comply with instructions or communicate bladder sensations adequately for urodynamic assessment. Inability to catheterise the bladder. Visible haematuria requiring separate investigation. Known or suspected urinary or genitourinary fistula. Inability to undergo two sequential bladder fills during the same testing session. Inability to provide informed consent.
Outcome results
None listed