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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Radiofrequency
DeviceAccording 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: patients who have never received pharmacological or medical device treatment for OABExperimental treatment 1 intervention
Group B: patients who have failed adequate therapy (≥12 weeks) with antimuscarinicsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improvement of 40% in the Overactive Bladder Symptoms Bother Questionnaire Score Short Form from the baseline score
Time frame
From enrollment to 12 weeks after last treatmentSponsors and contacts
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IRCCS San Raffaele
Lead sponsor
University of Campania Luigi Vanvitelli
Collaborator
Source ClinicalTrials.gov
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