Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder (HYPNOS)

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Incontinence, Urge; Overactive Bladder (OAB)

Treatments: Device: Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT07279142

HYPNOS

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly from screening until the last follow up

Exclusion criteria

• 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.
• Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• Pregnancy, the intention of pregnancy and nursing.
• Impaired immune system due to immunosuppressive diseases such as Acquired Immunodeficency Syndrome (AIDS) and Human Immunodeficency Virus (HIV), autoimmune disorders, or use of immunosuppressive medications.
• Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
• Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
• Any active condition in the treatment area, such as sores, eczema, and rash.
• History of vaginal disorders, keloids, abnormal wound healing.
• History of bleeding coagulopathies or use of anticoagulants in the last 10 days, as per the practitioner's discretion.
• Non-italian speakers
• Severely impaired mobility or cognition
• Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
• Repair of pelvic organ prolapse or incontinence procedure in the previous 6 months
• Ongoing complications of prior anti-incontinence surgery
• Received intravesical botulinum injection within the previous 12 months
• History of an implanted nerve stimulator for incontinence
• History of prior sling or vaginal mesh placement,
• Previous diagnosis of interstitial cystitis, bladder cancer, or chronic pelvic pain
• Current participation in any other conflicting interventional or OAB treatment study
• Planning to become pregnant during the study period.
• Pelvic radiation, history of pelvic radiation
• Active urinary tract or vaginal infection
• Anatomical conditions that would prevent the introduction and use of the device, in such as significant pelvic organ prolapse,
• Current hydronephrosis or hydroureter
• Bladder outflow obstruction
• Active pelvic organ malignancy
• Urethral obstruction
• Urinary retention or prolonged catheter use
• Less than 12 months post-partum or currently pregnant or plan to become pregnant in the following 12 months.
• Untreated symptomatic urinary tract infection
• Unevaluated hematuria
• Medical instability
• Allergy to anesthetics as Benzocaine/Lidocaine/Tetracaine Cream (BLT Cream) used in the study
• Not available for follow-up in 6 months
• Participation in other research trials that could influence results of this study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

patients who have never received pharmacological or medical device treatment for OAB

Experimental group

Description:

Transvaginal micro-radiofrequency with 7mm needles in patients who have never received pharmacological or medical device treatment for OAB (first-line group).

Treatment:

Device: Radiofrequency

patients who have failed adequate therapy (≥12 weeks) with antimuscarinics

Experimental group

Description:

Transvaginal micro-radiofrequency with 7 mm needles in patients who have failed adequate therapy (≥12 weeks) with antimuscarinics due to ineffectiveness, intolerance or contraindications (refractory group)

Treatment:

Device: Radiofrequency