The Effectiveness of Transvaginal Radiofrequency and Pelvic Floor Muscle Training Compared to Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- The change of signs, symptoms and impact of pelvic floor dysfunction (PFDI-20) between reviews (before, after and at six months of treatment in both groups).
研究概览
简要总结
The following clinical trial investigates the efficacy of transvaginal radiofrequency in the physiotherapy treatment of stress urinary incontinence (SUI). The treatment compares transvaginal radiofrequency with pelvic floor muscle training (PFMT) and PFMT alone.
The present study is a randomized controlled trial with double blinding (evaluator and patients).
The objective is to evaluate what radiofrequency can provide in the improving of the quality of life, symptoms and pelvic floor muscle strength of patients with SUI.
The reason for the combination with PFMT, is that it is the golden standard treatment in pelvic floor rehabilitation and SUI improvement.
详细描述
Urinary incontinence (UI) is a health burden for more than 200 million people in the world. 34% of women over the age of 40 experience or have already experienced some significant experience with UI, thus affecting their health-related quality of life (QoHR).
SUI is endowed with a complex and multifactorial pathophysiology, generally involving the pelvic floor musculature and adjacent collagen-dependent tissues that help in support.
According to the literature, there are two clearly described mechanisms:
- The loss of urethral support, of the anterior vaginal wall, transforming into urethral hypermobility.
- Deficiency of urethral closure, such as rotational descent of the proximal part of the urethra, of the pubourethral ligament, with loss of internal urethral integrity.
The pelvic floor musculature plays an important role in helping the urethral support, during voluntary contraction. If the muscles are weak, urine loss is greater.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The INDIBA radiofrequency device is randomized in a total of 99 programs, and in order of arrival, a number is assigned to each patient in which the intervention of the number is unknown. Patients will always be treated with the same program number, throughout all sessions.
The evaluations of the study will be carried out by the physiotherapist 1 (Yasmin Er Rabiai Boudallaa) who is blinded during the clinical trial.
And by the physiotherapist 2 (Marta Martínez Colmenar), is the responsible for the treatment of patients.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 20 - 75 years
- •Previously diagnosed SUI through assessment and questionnaires.
- •PAD Test of 1h with > or = 1gr of urine loss.
- •Urine losses in the last week.
- •Nulliparous and multiparous.
排除标准
- •Women > 75 years.
- •Another type of urinary incontinence, urge or mixed.
- •Difficulty urinating
- •Hematuria
- •Pregnancy
- •Patients with any type of cancer or with a personal history of it.
- •Previous surgeries for the treatment of SUI
- •Gynecological surgeries (hysterectomy, containment mesh for different prolapses).
- •Neurological and cognitive problems.
- •Injury to the spinal cord, lower limbs or pelvis.
- •Grade II, III or IV pelvic organ prolapse.
- •Vaginal or urinary infection.
- •Antimuscarinics (oxybutinin)
- •Toterodine
- •Solifenacin
- •Darifenacin
- •Fesoterodine
- •Anticholinergics
- •Antidepressants:
- •Duloxetine
- •Imipramine
- •Estrogens
- •Botulinum Toxin
- •Alpha-adrenergic agonists
- •Ephedrine
- •Pseudoephedrine
- •Antidiuretics (desmopressin)
结局指标
主要结局
The change of signs, symptoms and impact of pelvic floor dysfunction (PFDI-20) between reviews (before, after and at six months of treatment in both groups).
时间窗: Before treatment, six weeks of treatment, and 6 months assessments were required.
PFDI-20 : Pelvic Floor Distress Inventory Questionnaire - 20. It has 20 questions that are in turn divided into three symptomatic scales. The minimum value is 0, and the maximum is 300, which is the result of the sum of the total of the three subscales of 100 points of maximum value. This scale, the higher the value, the greater the pelvic floor dysfunction.
The change of signs, symptoms and impact of pelvic floor dysfunction (PFIQ-7) between reviews (before, after and at six months of treatment in both groups)
时间窗: Before treatment, six weeks of treatment, and 6 months assessments were required.
PFIQ-7 has 7 questions for each subscale, which are three in total. The minimum value is 0, and the maximum is 300, which is the result of the sum of the total of the three subscales of 100 points of maximum value. This scale, the higher the value, the greater the pelvic floor dysfunction.
Changes in the ICIQ-SF scale before, after and six months after treatment in both groups.
时间窗: Before treatment, six weeks of treatment, and 6 months assessments were required.
ICIQ-SF: International Consultation on Incontinence Questionnaire, short form. The minimum score is 0, and the maximum is 21. Where 0 is the absence of urinary incontinence and everything valued above 0 is a symptom of urinary incontinence. The higher the value, the worse the incontinence.
次要结局
- Changes in sexual function (FSFI) before, after and six months after treatment in both groups.(Before treatment, six weeks of treatment, and 6 months assessments were required.)
- Changes in the Pad Test 1h before, after and six months after treatment in both groups.(Before treatment, six weeks of treatment, and 6 months assessments were required.)
- Changes in Pelvic Muscle Excersice Self-Efficacy (Broome scale) before, after and six months after treatment in both groups.(Before treatment, six weeks of treatment, and 6 months assessments were required.)
- Changes in muscle tone before, after and six months after treatment in both groups.(Before treatment, six weeks of treatment, and 6 months assessments were required.)
- Changes in maximum and average strength of the pelvic floor before, after and six months after treatment in both groups. .(Before treatment, six weeks of treatment, and 6 months assessments were required.)
- Check the level of physical activity measured with the GPAQ scale, in both groups, before, after and at six months.(Before treatment, six weeks of treatment, and 6 months assessments were required.)
研究者
José Casaña Granell
Director, Head of the Department of Physiotherapy (University of Valencia), Clinical Professor.
University of Valencia