NCT04681625已完成不适用
Randomised Intervention Multicentre Study to Evaluate the Effect of Pelvic Floor Muscle Training in Men With BPH and OAB Treated With Silodosin - The SILODOSING Study
Comenius University2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2021年1月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.
研究概览
简要总结
This study will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with Silodosin.
详细描述
This is a randomised-intervention, parallel, multicentre study which will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with silodosin.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •willing to provide written informed consent
- •men over 50 years with lower urinary tract symptoms and overactive bladder and benign prostatic hyperplasia
- •persistence of overactive bladder despite 4 weeks of silodosin treatment
- •symptoms of overactive bladder (urinary frequency and urgency with or without urinary incontinence) for ≥3 months prior to visit
- •willing and able to complete the 3-day voiding diary and questionnaires
- •International Prostate Symptom Score (IPSS) score ≥
- •experience an average of 8 or more micturition's per day over the 3-day diary period.
- •experience an average of 2 episodes of urgency per day (grade 3 or 4) over the 3-diary period
排除标准
- •post-void residual volume (PVR) >200 mL
- •evidence of Urinary Tract Infection and haematuria
- •use anticholinergics, beta 3 mimetics within 4 weeks prior to Visit 1 and during the study
- •oncological diseases of the lower urinary tract and prostate
- •neurogenic bladder
- •urethral strictures and bladder neck stenosis
- •urolithiasis
- •diabetes mellitus
- •previous surgery of lower urinary tract
- •stress urinary incontinence
- •intermittent catheterisation
- •chronic urinary tract infection
- •previous botox treatment in the last 12 months
- •chronic electrostimulation treatment of OAB in the last 12 months
- •patient began or has changed a bladder training program or pelvic floor exercises less than 90 days before 1 visit
- •cognitive deficits and dementia
- •man has participated in an interventional trial within 30 days prior to Visit 1
- •total daily urine production over 2500 mL according to voiding diary
结局指标
主要结局
Change in the number of voidings and intensity of urgencies during 24 hours using a micturition diary.
时间窗: over 12 weeks of treatment
The investigators will compare change in the number of voidings and the intensity of urgencies during 24 hours in the combined silodosin and pelvic floor muscle training to silodosin treatment alone.
次要结局
- Change in patient global impression of improvement(over 12 weeks of treatment)
- Change in incontinence quality of life .(over 12 weeks of treatment)
- Incidence of adverse events .(over 12 weeks of treatment)
- Change in lower urinary tract symptoms.(over 12 weeks of treatment)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or EnzalutamideMetastatic Castration Resistant Prostate Cancer (mCRPC)NCT02130947UNC Lineberger Comprehensive Cancer Center
已完成
不适用
Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for ProlapsePelvic Organ ProlapseNCT00476892Glasgow Caledonian University448
已完成
不适用
Pelvic Floor Muscle Exercises and Core Exercises in Menopausal WomenKegel ExercisesCore StrengthMenopauseStress Urinary IncontinenceNCT06348342Trakya University136
Unknown
不适用
Gynecological Pelvic Floor Muscle TrainingUrinary IncontinenceNCT01811602University of British Columbia40
未知
4 期
The effect of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer.<p>rectal cancer, bowel symptoms (fecal incontinence, urgency, frequency, fragmented defecation, soiling), Low Anterior Resection Syndrome</p>Rectal cancer10017991NL-OMON26845Research Foundation Flanders125