NCT07327528

Monocentric Pilot Study for the Application of an Endourethral Device for the Treatment of Stress Urinary Incontinence

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Relief srl · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise. The prevalence of stress urinary incontinence is higher in older age groups, with 10% of women and 5% of men over the age of 65 suffering from this condition. The initial management of urinary incontinence consists of basic diagnostic investigations to rule out any reversible conditions (i.e., bacterial urinary tract infections, UTIs), while conservative and non-invasive treatment options include lifestyle changes, (PFMT) with or without biofeedback, and bladder retraining.

Detailed description

Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing. It is estimated to be the most common type of urinary incontinence worldwide due to its high prevalence in women. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise. It can be primary or secondary and is caused by damage to either the sphincter innervation or the anatomical structures that make up the urethral sphincter. It is usually classified according to its severity and, consequently, according to the impairment of the patient's quality of life. It can seriously affect patients' quality of life in severalareas, leading to conditions such as sexual dysfunction, social isolation, withdrawal from physical activity, and major depression. The initial management of urinary incontinence consists of basic diagnostic investigations to rule out any reversible conditions (i.e., bacterial urinary tract infections, UTIs), while conservative and non-invasive treatment options include lifestyle changes, pelvic floor muscle training (PFMT) with or without biofeedback and bladder retraining, as well as the chronic and daily use of external aids (diapers). The goal of treatment is to achieve complete or partial continence, with the aim of restoring normal sexual function. (PFMT) with or without biofeedback and bladder retraining, as well as the chronic and daily use of external aids (diapers, collection systems, prophylactics, etc.). However, this does not guarantee the restoration of a good quality of life. The current guidelines of the European Association of Urology (EAU) recommend surgical treatment when conservative and pharmacological therapies fail. In men, the most common surgical treatment for stress urinary incontinence that does not respond to therapy is the implantation of an artificial urethral sphincter, while in women, the indication is for complicated stress urinary incontinence (failure of other treatments such as retropubic or transobturator mid-retral slings). Currently, the most widely used device is a three-chamber device (consisting of a cuff, a balloon, and a pump) placed extraurethrally, whose application requires general and/or spinal anesthesia. The system proposed in the study, on the other hand, is an endourethral device to be applied endoscopically after anesthesia. The device is applied through a simple endoscopic maneuver without the need for other devices implanted in other anatomical sites and can be activated by slight abdominal pressure exerted by the patient.

Conditions

• Urinary Incontinence , Stress

Interventions

Type	Name	Description
DEVICE	UroRelief, a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence.	UroRelief is a sterile, single-use, endourethral medical device suitable for both men and women, which is positioned at the bladder neck for the treatment of stress incontinence. The device is designed to be inserted through the urethra using a routine endoscopic procedure with a resectoscope. Once in place, the device is completely inside the body with no visible parts outside and can restore urinary continence control.

Timeline

• Start date: 2025-07-09
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Italy