Urinary Incontinence , StressBWT-IUSNCT06740058
Bladder Wall Thickness in Symptomatic Urinary Stress Incontinence and Its Correlation with Urodynamics Results
An observational study of Urinary Incontinence , Stress and Incontinence, run by IRCCS San Raffaele.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence , Stress, Incontinence
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pure or prevalent stress urinary incontinence who undergo invasive urodynamic examination
Who may be able to join
- 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.
- Patients undergoing invasive urodynamic examination for objective assessment of their symptoms or in preparation for possible anti-incontinence surgery.
Who cannot join
- 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.
- Patients with pelvic organ prolapse > II stage.
- Patients with chronic bladder retention.
- Patients with neurological diseases that may affect bladder function and urodynamic results.
- Participants unwilling or unable to give informed consent for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bladder Wall Thickness in Symptomatic Urinary Stress Incontinence and Its Correlation with Urodynamics Results. a Retrospective and Prospective Observational Study
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
- Medical subject headings
- Urinary Incontinence, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder wall thickness in millimeters (mm) in two different bladder points (dome and trigone) in patients with or without detrusor overactivity at urodynamic assessment
Measured: From enrollment to the urodynamic examination that will be performed with 6 months from baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence , StressStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Salvatore, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740058
- Sponsor's protocol ID
- BWT-IUS
- Acronym
- BWT-IUS
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Wall Thickness in Symptomatic Urinary Stress Incontinence and Its Correlation with Urodynamics Results. a Retrospective and Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06740058
- Acronym / sponsor ID
- BWT-IUS / BWT-IUS
- Conditions
- Urinary Incontinence , Stress, Incontinence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pure or prevalent stress urinary incontinence who undergo invasive urodynamic examination
Key inclusion criteria (5 listed)
- 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.
- Patients undergoing invasive urodynamic examination for objective assessment of their symptoms or in preparation for possible anti-incontinence surgery.
Key exclusion criteria (8 listed)
- 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.
- Patients with pelvic organ prolapse > II stage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bladder wall thickness in millimeters (mm) in two different bladder points (dome and trigone) in patients with or without detrusor overactivity at urodynamic assessment
Time frame: From enrollment to the urodynamic examination that will be performed with 6 months from baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence , Stress and Incontinence, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vittoria Benini (00393937126100, benini.vittoria@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder wall thickness in millimeters (mm) in two different bladder points (dome and trigone) in patients with or without detrusor overactivity at urodynamic assessment (time frame: From enrollment to the urodynamic examination that will be performed with 6 months from baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.