NCT07279142尚未招募不适用
Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Improvement of 40% in the Overactive Bladder Symptoms Bother Questionnaire Score Short Form from the baseline score
研究概览
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.
- •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
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 (2)
Loading locations...
相似试验
尚未招募
不适用
se of new technologies for the treatment of vaginal sequelae caused by radiotherapy.Vaginal atresiaRBR-2x4hqmFaculdade de Medicina da Universidade Federal do Rio Grande do Sul
已完成
不适用
The Effectiveness of Transvaginal Radiofrequency in Women With Stress Urinary IncontinenceUrinary Incontinence,StressPelvic Floor DisordersUrinary IncontinencePelvic Floor Muscle WeaknessNCT05702567José Casaña Granell42
尚未招募
3 期
Interventional study with GYIDE system for ablation of fibroids under ultrasound guidance.CTRI/2024/07/070536esa Medtech Private Limited
已完成
不适用
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot TrialVaginal LaxityNCT04227392Seoul National University Hospital30
尚未招募
不适用
Radiofrequency within the vagina in the treatment of involuntary urine loss: Randomized clinical trialrinary incontinenceC12.777.934.852RBR-9wfww5Programa de Pós-Graduação em Gerontologia Biomédica da Pontifícia Universidade Católica do Rio Grande do Sul