Pilot Study of the ARTUS® Artificial Urinary Sphincter on Women
NCT07641218
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Paris, France
View Trial DetailsNCT Number: NCT06740058
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
Trial opening soon.
Get Notified18 year and older
Female
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrollment to the urodynamic examination that will be performed with 6 months from baseline visit
Contact information is provided by the study sponsor or research team.
IRCCS San Raffaele
Other
Bladder Wall Thickness in Symptomatic Urinary Stress Incontinence and Its Correlation with Urodynamics Results. a Retrospective and Prospective Observational Study
Acronym: BWT-IUS
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