Efficacy and Safety of 6 Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Variation in patient bladder voiding diaries' results at follow up visits versus baseline
研究概览
简要总结
The investigator wants to evaluate the efficacy of a specific intravaginal Electrical Muscle Stimulation (EMS), in the treatment of exclusive or predominant stress urinary incontinence (SUI) symptoms in women. The investigator's aim is to determine the device's impact (the device is VTone) on reducing urinary incontinence episodes and on improving women's quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Women with minimum age of 18 years .
- •Documented clinical diagnosis of exclusive or predominant stress urinary incontinence.
- •Willingness to comply with study procedures and follow-up visits.
- •Signed informed consent to participate in the study.
- •BMI </= 30.
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
- •Impaired immune system due to immunosuppressive diseases such as AIDS and HIV 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 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 treatment study
- •Active urinary tract or vaginal infection
- •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
- •Untreated symptomatic urinary tract infection
- •Unevaluated hematuria
- •Not available for follow-up in 6 months
- •Participation in other research trials that could influence results of this study
研究组 & 干预措施
Women with stress urinary incontinence treated with intravaginal electrical muscle stimulation
We will include women suffering from stress urinary incontinence who will be treated with intravaginal electrical muscle stimulation with a device called VTone. VTone is a small anatomically shaped applicator that delivers intravaginal electrical muscle stimulation This device includes an ogival, circular body, with a handle at one end of the body and a head at the other end of the body. The head includes a substantially flat, metallic surface. The device should be used with gel. The treatment will include 6 sessions (sessions will be planned once a week) and women will be asked to fill in a bladder voiding diary and validated questionnnaires at baseline and at follow up visits (one and three months after the last treatment).
干预措施: Electrical intravaginal muscle stimulation (Device)
结局指标
主要结局
Variation in patient bladder voiding diaries' results at follow up visits versus baseline
时间窗: Follow up visits: 1 month and 3 months after the last session of treatment
Eligible subjects will receive a total of 8 treatments (once a week) using the transvaginal electrical stimulation. All subjects will be required to return to the clinic at 1 month and 3 months after the last treatment. At baseline and during the two follow up visits patients will be asked to fill in a bladder voiding diary.
次要结局
未报告次要终点
研究者
Stefano Salvatore
Professor
IRCCS San Raffaele