Overactive Bladder (OAB)HYPNOSNCT07279142
Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder
A study testing Radiofrequency in people with Overactive Bladder (OAB) and Incontinence, Urge, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB), Incontinence, Urge
- What is being tested?
- Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2025to 24 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Stefano Salvatore Professor, 0039 3472757131, salvatore.stefano@hsr.it
About this study
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
- Being tested
- Radiofrequency
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Device: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of 40% in the Overactive Bladder Symptoms Bother Questionnaire Score Short Form from the baseline score
Measured: From enrollment to 12 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start16 Dec 2025 (estimated)
- Primary completion13 Nov 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Responsible party
- Principal investigator, Stefano Salvatore, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279142
- Sponsor's protocol ID
- HYPNOS
- Acronym
- HYPNOS
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31359508Abdelaziz 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.
PubMed 34288106Cespedes RD, Cross CA, McGuire EJ. Modified Ingelman-Sundberg bladder denervation procedure for intractable urge incontinence. J Urol. 1996 Nov;156(5):1744-7.
PubMed 8863585Dayan 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.
PubMed 31321190Takahashi 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.
PubMed 12794570
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder
- ClinicalTrials.gov ID
- NCT07279142
- Acronym / sponsor ID
- HYPNOS / HYPNOS
- Conditions
- Overactive Bladder (OAB), Incontinence, Urge
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Study start
- 16 Dec 2025 (estimated)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who have never received pharmacological or medical device treatment for OAB | Experimental | Device: RadiofrequencyTransvaginal micro-radiofrequency with 7mm needles in patients who have never received pharmacological or medical device treatment for OAB (first-line group). |
| patients who have failed adequate therapy (≥12 weeks) with antimuscarinics | Experimental | Device: RadiofrequencyTransvaginal 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequencyAccording 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. | Device | patients who have failed adequate therapy (≥12 weeks) with antimuscarinics, patients who have never received pharmacological or medical device treatment for OAB |
Primary outcome
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 treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Background: PubMed 31359508Rovner 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.
- Background: PubMed 34288106Abdelaziz 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.
- Background: PubMed 8863585Cespedes RD, Cross CA, McGuire EJ. Modified Ingelman-Sundberg bladder denervation procedure for intractable urge incontinence. J Urol. 1996 Nov;156(5):1744-7.
- Background: PubMed 31321190Dayan 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.
- Background: PubMed 12794570Takahashi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency in people with Overactive Bladder (OAB) and Incontinence, Urge, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Salvatore Professor (0039 3472757131, salvatore.stefano@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07279142, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.