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| Name | Class |
|---|---|
| University of Campania Luigi Vanvitelli | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Salvatore Professor | Contact | 0039 3472757131 | salvatore.stefano@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | Italy | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31359508 | Background | 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. | |
| 34288106 | 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. |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 8863585 | 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. |
| 31321190 | 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. |
| 12794570 | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |