Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Treatment of Overactive Bladder. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Urinary frequency
研究概览
简要总结
The main aim of this study, is compare the effectiveness of transcutaneous posterior tibial nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive bladder.
详细描述
Overactive bladder syndrome (OAB) is a set of symptoms characterized by urge, with or without urge incontinence, usually with frequency and nocturia in the absence of urinary infection or other pathologies. OAB affect considerably the quality of life of the subject who suffer.
The first line of treatment is a conservative management as behavioral interventions, followed by pharmacological management as antimuscarinic or antimuscarinic drugs.
Percutaneous tibial nerve stimulation (PTNS) is present as another alternative of treatment. Previous studies have shown the positive effects of PTNS in a reduction on OAB symptoms.
The PTNS was described by Stoller in 1999. It's a electrical stimulation of the tibial nerve, inserting a 34 gauge needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia, to stimulation of the sacral segments S2 and S3, where the spinal centre of bladder is located. The parameters used are 20Hz and 200 µs, 12 sessions, two weekly, 30 min treatment.
The PTNS is a minimal invasive technique, but can be utilized surface electrodes instead of needle to minimize the discomfort of prick.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects diagnosis of overactive bladder
- •Subjects refractory to treatments antimuscarinic or beta 3-agonist
- •Subjects who do not take restricted medication
- •Subjects who can cognitively complete the voiding diary and questionnaires
- •Subject with symptoms 3 months ago
- •Men must be discarded obstruction by benign prostatic hyperplasia
排除标准
- •Subjects with stress incontinence
- •Subjects with urinary tract infection
- •Subjects with neurological disease
- •Subjects with pacemakers fitted
- •Pregnancy
- •Subjects who have disorder sensitive
- •A history of pelvic tumors
- •Subject who is not able to understand the physiotherapist
结局指标
主要结局
Urinary frequency
时间窗: two years
Urinary episodes per day. According to international consensus, it is considered pathological when: There are more than 8 episodes of urination per day
Urge episodes
时间窗: two years
Urinary urge episodes per day. The degree of urgency is measured through the PPIUS scale (outcome no. 4). A grade 3-4 on the PPIUS scale is considered pathological.
Voided volume
时间窗: two years
Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.
Degree of urge to void
时间窗: two years
Measured through the PPIUS (Patient Perception of Intensity of Urgency Scale). Scale from 0 to 4, where: 0 = No urgency; 1. = Slight urgency; 2. = Moderate urgency; 3. = severe urgency; 4. = urge incontinence.
Nightime voids
时间窗: two years
Urinary episodes per night. According to international consensus, it is considered pathological when: There is more than 1 episode per night.
次要结局
- Overactive Bladder questionnaire Short- Form (OABq-SF)(Two years)
- International Consultation on Incontinence Questionnaire (ICIQ-SF)(Two years)
- Benefits, satisfaction and willingness to continue to treatment (BSW)(Two years)