Bladder Wall Thickness in Symptomatic Urinary Stress Incontinence and Its Correlation with Urodynamics Results

NCT ID: NCT06740058

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-02-28

Brief Summary

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

Conditions

Urinary Incontinence , Stress; Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study.

2. Women aged > 18 y.o.

3. Women symptomatic for pure or predominant stress incontinence attending the urogynecology outpatient clinic at our institution.

4. Patients undergoing urogynecological standard evaluation for their symptoms, including outpatient gynecological visit and a transvaginal ultrasound.

5. Patients undergoing invasive urodynamic examination for objective assessment of their symptoms or in preparation for possible anti-incontinence surgery.

Exclusion Criteria

1. Patients with pure or predominant OAB symptomatology

2. Current use of antimuscarinic agents or beta3-agonists (for example Mirabegron)

3. Presence of urological or gynecological cancer.

4. Patients with previous anti-incontinence surgery.

5. Patients with pelvic organ prolapse > II stage.

6. Patients with chronic bladder retention.

7. Patients with neurological diseases that may affect bladder function and urodynamic results.

8. Participants unwilling or unable to give informed consent for participation in the study.

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

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Stefano Salvatore

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Vittoria Benini

Role: CONTACT

Phone: 00393937126100

Email: benini.vittoria@hsr.it

Other Identifiers

BWT-IUS

Identifier Type: -

Identifier Source: org_study_id