NCT07279142

Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigator hypothesizes that controlled delivery of low heat (45-50 Centigrade) to the sub-detrusor and detrusor muscle can ablate the autonomic nerve endings and control overactive bladder symptoms without causing significant damage to the surrounding structures. Low heat in such a manner is below urethral sensation and enables office treatment. The transvaginal approach is non-invasive and improves overactive bladder (OAB) symptoms and patients' quality of life. The investigator believes that the RF administration results could be equal or better for first-line treated patients compared to pharmacological refractory patients.

Conditions

• Overactive Bladder (OAB)
• Incontinence, Urge

Interventions

Type	Name	Description
DEVICE	Radiofrequency	According to the study protocol, eligible subjects will receive one treatment within 3 weeks of screening. After one month, if there is no satisfactory result, a second treatment will be administered, and after another month, the patient will be evaluated. If there is still no end point, a third treatment will be given. It should be noted that the second and third treatments will only be performed if there is no satisfactory result after the previous treatment. Treatment area: Treatment area will include vaginal canal. Treatment Procedure: * Subjects receive HYPNOS treatment with device using radiofrequency (RF). Treat vaginal canal at the depth starting from approximately 3.5cm from introitus to the distal end of vagina. Radially the treatment area is from 9 to 3 o'clock. * Patient should empty bladder prior to treatment * Position patient in lithotomy position * Set energy to levels well tolerated by the subject. Suggested settings: Burst Mode 7mm, 1 pass.

Timeline

• Start date: 2025-12-16
• Primary completion: 2026-11-13
• Completion: 2026-12-24
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: Italy