Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Effects of transcutaneous perineal stimulation compared to anal stimulation
研究概览
简要总结
This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.
Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.
详细描述
Pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. Perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention.
The perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. The two techniques are commonly used. Each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.
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 (Outcomes Assessor)
盲法说明
Single Blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Having undergone a radical prostatectomy surgical procedure.
- •Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III)
- •Do not exceed the year since the surgical intervention.
- •Accept to participate in the study and grant signed informed consent.
排除标准
- •Follow a pharmacological treatment for the UI.
- •Presenting anatomical malformations of the pelvic floor musculature.
- •Carry pacemaker.
- •Present anal fistulas.
- •suffer from serious psychic disorders.
- •Presenting lower urinary tract infections.
研究组 & 干预措施
Transcutaneous perineal stimulation
Patient is asked to lie down with legs slightly bend and two adhesive electrodes are attached transcutaneous on base of penis and on perineum. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.
干预措施: Transcutaneous perineal stimulation (Other)
Anal stimulation
Patient is asked to lie down with legs slightly bend and an electrical probe is inserted into the anus. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.
干预措施: Anal stimulation (Other)
结局指标
主要结局
Effects of transcutaneous perineal stimulation compared to anal stimulation
时间窗: Baseline, 6 and 10 weeks
A change of the urine grams last in 24 hours
次要结局
- Assess adverse effects(10 weeks)
- Asses quality of life(Baseline and 10 weeks)
研究者
Regina Pané Alemany
Principal investigator
RAPbarcelona