Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder

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.

NCT Number	NCT07279142
Lead Sponsor	IRCCS San Raffaele Collaborators: University of Campania Luigi Vanvitelli
Conditions	Overactive Bladder (OAB), Incontinence, Urge
Enrollment	48 participants
Start Date	2025-12-16
Primary Completion	2026-11-13 (estimated)
Study Completion	2026-12-24 (estimated)
Updated on ClinicalTrials.gov	2025-12-12