Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder

NCT07279142 | Not Yet Recruiting

• 1 other identifier: HYPNOS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Improvement of 40% in the Overactive Bladder Symptoms Bother Questionnaire Score Short Form from the baseline score

  From enrollment to 12 weeks after last treatment

Study Arms (2)

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

EXPERIMENTAL

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

Device: Radiofrequency

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

EXPERIMENTAL

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)

Device: Radiofrequency

Interventions

Radiofrequency DEVICE

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.

patients who have failed adequate therapy (≥12 weeks) with antimuscarinics; patients who have never received pharmacological or medical device treatment for OAB

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Università della Campania Luigi Vanvitelli: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

Location

Related Publications (5)

• Rovner ES, Versi E, Le Mai T, Dmochowski RR, De Wachter S. One-year results with selective bladder denervation in women with refractory overactive bladder. Neurourol Urodyn. 2019 Nov;38(8):2178-2184. doi: 10.1002/nau.24110. Epub 2019 Jul 29.

  PMID: 31359508 BACKGROUND

• Abdelaziz A, Dell J, Karram M. Transvaginal radiofrequency energy for the treatment of urinary stress incontinence: A comparison of monopolar and bipolar technologies in both pre- and post-menopausal patients. Neurourol Urodyn. 2021 Sep;40(7):1804-1810. doi: 10.1002/nau.24748. Epub 2021 Jul 20.

  PMID: 34288106 BACKGROUND

• Cespedes RD, Cross CA, McGuire EJ. Modified Ingelman-Sundberg bladder denervation procedure for intractable urge incontinence. J Urol. 1996 Nov;156(5):1744-7.

  PMID: 8863585 BACKGROUND

• Dayan E, Ramirez H, Westfall L, Theodorou S. Role of Radiofrequency (Votiva, InMode) in Pelvic Floor Restoration. Plast Reconstr Surg Glob Open. 2019 Apr 25;7(4):e2203. doi: 10.1097/GOX.0000000000002203. eCollection 2019 Apr.

  PMID: 31321190 BACKGROUND

• Takahashi T, Garcia-Osogobio S, Valdovinos MA, Belmonte C, Barreto C, Velasco L. Extended two-year results of radio-frequency energy delivery for the treatment of fecal incontinence (the Secca procedure). Dis Colon Rectum. 2003 Jun;46(6):711-5. doi: 10.1007/s10350-004-6644-8.

  PMID: 12794570 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Central Study Contacts

Stefano Salvatore Professor

CONTACT

0039 3472757131; salvatore.stefano@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 12, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): December 24, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)