NCT04862533

Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University Hospital Olomouc · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer
• Urinary Incontinence
• Beta-Alanine
• Pelvic Floor Muscle Training
• Radical Prostatectomy

Interventions

Type	Name	Description
DRUG	Beta-Alanine	Participants will receive 1150mg of beta-alanine three times a day
DRUG	Placebo	Participants will receive matching placebo three times a day
PROCEDURE	Pelvic floor muscle training (PFMT)	Participants in both groups will undergo PFMT training program

Timeline

• Start date: 2020-02-01
• Primary completion: 2022-08-01
• Completion: 2022-10-01
• First posted: 2021-04-28
• Last updated: 2022-12-16

Locations

1 site across 1 country: Czechia