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

Sponsor
University Hospital Olomouc (Other)
Overall Status
Recruiting
CT.gov ID
NCT04862533
Collaborator
Palacky University (Other)
60
Enrollment
1
Location
2
Arms
34
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

    Drug: Placebo
    Participants will receive matching placebo three times a day
    Other Names:
  • Control group

    • Procedure: Pelvic floor muscle training (PFMT)
    Participants in both groups will undergo PFMT training program

    Outcome Measures

    Primary Outcome Measures

    1. Time to Continence (days) [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 Outcome Measures

    1. Assessment of physical activity of participants [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital Olomouc Olomouc Czechia 77900

    Sponsors and Collaborators

    • University Hospital Olomouc
    • Palacky University

    Investigators

    • Principal Investigator: Vladimir Student, MD, PhD, Dpt. of Urology, University hospital Olomouc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vladimir Student, M.D., Ph.D., Director of the study, University Hospital Olomouc
    ClinicalTrials.gov Identifier:
    NCT04862533
    Other Study ID Numbers:
    • BELA2020
    • URIRAPRO(2020)
    First Posted:
    Apr 28, 2021
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis

    Study Results

    No Results Posted as of Mar 9, 2022