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

Prostate Cancer Clinical Trial

— BELA  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862533
• Other study ID #: BELA2020
• Secondary ID: URIRAPRO(2020)
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2022
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

• Inclusion Criteria:
• Age 40-80 years
• Able to give informed consent
• Histologically proven prostate cancer
• BMI <35
• No other cancer treatment
• Continent
• Good physical and mental activity
• On normal diet
• Scheduled for radical prostatectomy (open or robotic)
• Exclusion Criteria:
• 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

Related Conditions & MeSH terms

• Enuresis
• Prostate Cancer
• Radical Prostatectomy
• Urinary Incontinence

Intervention

Drug:
• Beta-Alanine
Participants will receive 1150mg of beta-alanine three times a day
• 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

Locations

Country	Name	City	State
Czechia	University hospital Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Olomouc	Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Continence (days)	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	up to 6 months
Secondary	Assessment of physical activity of participants	To assess physical activity of the participants using Physical activity level (PAL), the number of participants having recommended PAL (PAL 1.75: a weekly average PAL of =1.75) < 1.4 = extremely inactive, > 2.4 = extremely active	up to 6 months
Secondary	Number of participants with laboratory abnormalities as measure of safety	Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined	up to 6 months
Secondary	Number of participants with adverse events	Incidence of adverse events in the combined beta-alanine and PFMT compared to PFMT and placebo treatment. Surgical complications will be evaluated according to Clavien-Dindo classification	up to 6 months
Secondary	Assessment of quality of life (QoL) change in both groups of participants	During the study period, participants will be asked to fill in clinical validated EuroQuol-5dimensions-5levels (EQ-5D-5L) questionnaire 0 = the worst to 100 = the best QoL outcome	up to 6 months
Secondary	Muscle carnosine concentration	Integrity and architecture of muscle tissue will be assessed in 4 µm thick sections of formalin-fixed, paraffin-embedded, hematoxylin-eosin stained tissue samples.	at week 4 (surgery)