About this trial
This clinical study aims to assess the utility of ultrasonographic bladder wall thickness (BWT) measurement in patients suffering from symptomatic stress urinary incontinence (SUI). SUI is a condition characterized by involuntary leakage of urine during activities that increase intra-abdominal pressure and represents a very frequent disorder impacting women's quality of life. To diagnose SUI more accurately and especially before surgical treatment, patients undergo invasive urodynamic examination. This examination allows us to objectify the presence of any bladder dysfunction and, in particular, to evaluate the presence of detrusor overactivity. Detrusor overactivity is defined as any occurrence of detrusor contraction(s) during filing cystometry. These contractions, which may be spontaneous or provoked, produce a waveform on the cystogram, of variable duration and amplitude and may cause or not urgency symptoms. In absence of any urodynamic detrusor overactivity, the patient may be diagnosed with pure SUI. This is essential to assess before surgical treatment to avoid worsening of symptoms and to decide whether to treat the patient with concomitant pharmacological treatment. On the contrary, ultrasonography offers a non-invasive and accessible approach to evaluate bladder function. This study will involve a cohort of patients with SUI, who will undergo ultrasonographic assessment of BWT and preoperative urodynamic assessment. The objective is to determine whether BWT correlates with the urodynamics results and whether it can predict the presence or absence of detrusor overactivity and confirm the pure stress urinary incontinence
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for participation in the study.
Women aged > 18 y.o.
Women symptomatic for pure or predominant stress incontinence attending the urogynecology outpatient clinic at our institution.
Patients undergoing urogynecological standard evaluation for their symptoms, including outpatient gynecological visit and a transvaginal ultrasound.
Disqualifiers
Patients with pure or predominant OAB symptomatology
Current use of antimuscarinic agents or beta3-agonists (for example Mirabegron)
Presence of urological or gynecological cancer.
Patients with previous anti-incontinence surgery.
Trial population
Patients with pure or prevalent stress urinary incontinence who undergo invasive urodynamic examination
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Bladder wall thickness in millimeters (mm) in two different bladder points (dome and trigone) in patients with or without detrusor overactivity at urodynamic assessment
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: