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Search / Trial NCT06740058

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

Launched by IRCCS SAN RAFFAELE · Dec 17, 2024

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to evaluate women who experience stress urinary incontinence (SUI), a condition where urine leaks during activities like coughing or exercising. The study aims to see if measuring the thickness of the bladder wall using ultrasound can help determine if there are any issues with bladder function, particularly focusing on a condition called detrusor overactivity, which can cause urgency or leakage. By comparing these ultrasound measurements with results from a standard bladder test (called urodynamics), researchers hope to find a non-invasive method to better diagnose SUI and potentially improve treatment options.

To participate, women over 18 who have symptoms of SUI and are seeking evaluation at a urogynecology clinic may be eligible. Participants will undergo an ultrasound to measure bladder wall thickness and also have a urodynamic examination to assess their bladder function. It’s important to note that certain individuals, such as those with specific bladder issues or previous surgeries, may not qualify for the study. This research could lead to better diagnosis and treatment strategies for women suffering from urinary incontinence, helping to enhance their quality of life.

Gender

FEMALE

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.

About Irccs San Raffaele

IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported