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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Prostate Cancer; Radical Prostatectomy; Pelvic Floor Muscle Training; Beta-Alanine
• Intervention / Treatment: Drug: Beta-Alanine; Procedure: Pelvic floor muscle training (PFMT); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vladimir Student, MD, PhD; Phone Number: +420 737807881; Email: vladastudent@gmail.com

Study Locations

• Czechia
  • Olomouc, Czechia, 77900
    • Recruiting
    • University Hospital Olomouc
    • Contact: Vladimir Student, MD,PhD; Phone Number: +420 737807881; Email: vladastudent@gmail.com
    • Principal Investigator: Vladimir Student, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Beta-Alanine; Participants will receive 1150mg of beta-alanine three times a day; Other Names: Intervention group; Procedure: Pelvic floor muscle training (PFMT); Participants in both groups will undergo PFMT training program
Experimental: 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.	Procedure: Pelvic floor muscle training (PFMT); Participants in both groups will undergo PFMT training program; Drug: Placebo; Participants will receive matching placebo three times a day; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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)

Collaborators and Investigators

• Sponsor: University Hospital Olomouc
• Collaborators: Palacky University
• Investigators: Principal Investigator: Vladimir Student, MD, PhD, Dpt. of Urology, University hospital Olomouc

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: BELA2020; URIRAPRO(2020) (Other Identifier: University Hospital Olomouc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No