NCT07279142
尚未招募
不适用
Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Improvement of 40% in the Overactive Bladder Symptoms Bother Questionnaire Score Short Form from the baseline score
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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
排除标准
- •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.
结局指标
主要结局
Improvement of 40% in the Overactive Bladder Symptoms Bother Questionnaire Score Short Form from the baseline score
时间窗: From enrollment to 12 weeks after last treatment
次要结局
未报告次要终点
研究者
Stefano Salvatore
Professor
IRCCS San Raffaele
研究点 (1)
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