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Completed

NCT Number: NCT04862533

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.

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Key information

Conditions

Prostate Cancer Beta-alanine Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Training Prostatic Diseases Prostatic Neoplasms Radical Prostatectomy Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Olomouc

Olomouc, 77900, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Beta-Alanine

Drug

Participants will receive 1150mg of beta-alanine three times a day

Other names: Intervention group

Placebo

Drug

Participants will receive matching placebo three times a day

Other names: Control group

Pelvic Floor Muscle Training (PFMT)

Procedure

Participants in both groups will undergo PFMT training program

Primary outcomes

  1. Time to Continence (days)

    Time frame: 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

Secondary outcomes

  1. Assessment of physical activity of participants

    Time frame: up to 6 months

    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

  2. Number of participants with laboratory abnormalities as measure of safety

    Time frame: up to 6 months

    Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined

  3. Number of participants with adverse events

    Time frame: up to 6 months

    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

  4. Assessment of quality of life (QoL) change in both groups of participants

    Time frame: up to 6 months

    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

  5. Muscle carnosine concentration

    Time frame: at week 4 (surgery)

    Integrity and architecture of muscle tissue will be assessed in 4 µm thick sections of formalin-fixed, paraffin-embedded, hematoxylin-eosin stained tissue samples.

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Palacky University

Registry information

Official study 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)

Acronym: BELA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2021
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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