Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

Qualifiers

age>18 years old

Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow-up visits, and testing schedules.

Urinary incontinence, predominant urgency incontinence, with moderate-severe overactive bladder, International Consultation on Incontinence Questionnaire - Overactibe Bladder Short Form (ICIQ-OABSS) score ≥6.

Ability and willingness to self-catheterize in case this is necessary.

Disqualifiers

Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.

Any permanent implant or an injected chemical substance in the treatment area.

Superficial areas that have been injected with hyaluronic acid (HA)/collagen/fat injections or other augmentation methods with bio-material during last 6 months.

Current or history of cancer, or current condition of any other type of cancer, or premalignant moles.

Trial design

Treatments tested in this trial

  • Radiofrequency

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS San Raffaele

Lead sponsor

University of Campania Luigi Vanvitelli

Collaborator