A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to Continence (days)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of beta-alanine in combination with pelvic floor muscle training (PFMT) compared to PFMT plus placebo in men undergoing radical prostatectomy.
详细描述
This study will assess efficacy of beta-alanine in combination with PFMT for the treatment of participants with urinary incontinence after radical prostatectomy. B-alanine is a component of L-carnosine (with L-histidine), which is needed for its synthesis. Βeta-alanine, thanks to its bioavailability) is a commonly used supplement that can improve exercise performance by increasing the amount of carnosine in striated muscle tissues. Supplementation of beta-alanine in elderly patients has resulted in an increase in physical activity, less fatigue and overall increase in L-carnosine concentration in muscles. PFMT utilization is considered a strong predictor of early return of urinary continence after radical prostatectomy (RP). We hypothesize, that combination of PFMT with beta-alanine could result in improved urinary continence after RP. The intervention will start 30 days before the surgery and will continue until primary outcome is met. Beta-alanine/placebo will be given daily. Efficacy, pharmacokinetics, biomarkers, tissue histology, participants reported outcomes and safety will be assessed. The total duration of study will be approximately 6 months.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years
- •Able to give informed consent
- •Histologically proven prostate cancer
- •No other cancer treatment
- •Continent
- •Good physical and mental activity
- •On normal diet
- •Scheduled for radical prostatectomy (open or robotic)
排除标准
- •Other malignant cancer (except for benign skin cancer)
- •Age > 80 years
- •Diabetes mellitus (any type)
- •Chronic bowel inflammatory disease
- •Urinary incontinence
- •Impaired mental activity
- •Previous radiotherapy of hormonal therapy
- •Vegetarian/vegan/on macrobiotic diet
研究组 & 干预措施
Beta-alanine + PFMT
Participants will ingest an active supplement containing beta-alanine for a period of maximum 6 months. During the whole period, participants will take part in a structured program of PMFT. After first month, the participants will undergo radical prostatectomy.
干预措施: Beta-Alanine (Drug)
Beta-alanine + PFMT
Participants will ingest an active supplement containing beta-alanine for a period of maximum 6 months. During the whole period, participants will take part in a structured program of PMFT. After first month, the participants will undergo radical prostatectomy.
干预措施: Pelvic floor muscle training (PFMT) (Procedure)
Placebo + PFMT
Participants will ingest a placebo supplement containing no beta-alanine for a period of maximum 6 months. During the whole period, participants will take part in a structured program of PMFT. After first month, the participants will undergo radical prostatectomy.
干预措施: Placebo (Drug)
Placebo + PFMT
Participants will ingest a placebo supplement containing no beta-alanine for a period of maximum 6 months. During the whole period, participants will take part in a structured program of PMFT. After first month, the participants will undergo radical prostatectomy.
干预措施: Pelvic floor muscle training (PFMT) (Procedure)
结局指标
主要结局
Time to Continence (days)
时间窗: up to 6 months
Continence is defined by number of pads used and measured by one hour pad test. Number of pads use will be determined according to EPIC-SF questionnaire
次要结局
- Assessment of physical activity of participants(up to 6 months)
- Number of participants with laboratory abnormalities as measure of safety(up to 6 months)
- Number of participants with adverse events(up to 6 months)
- Assessment of quality of life (QoL) change in both groups of participants(up to 6 months)
- Muscle carnosine concentration(at week 4 (surgery))
研究者
Vladimir Student, M.D., Ph.D.
Director of the study
University Hospital Olomouc