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

NCT04862533 | Completed

• 2 other identifiers: BELA2020URIRAPRO(2020)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of physical activity of participants

  up to 6 months

• Number of participants with laboratory abnormalities as measure of safety

  up to 6 months

• Number of participants with adverse events

  up to 6 months

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

  up to 6 months

• Muscle carnosine concentration

  at week 4 (surgery)

Study Arms (2)

Beta-alanine + PFMT

EXPERIMENTAL

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; Procedure: Pelvic floor muscle training (PFMT)

Placebo + PFMT

EXPERIMENTAL

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; Procedure: Pelvic floor muscle training (PFMT)

Interventions

Beta-Alanine DRUG

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

Also known as: Intervention group

Beta-alanine + PFMT

Placebo DRUG

Participants will receive matching placebo three times a day

Also known as: Control group

Placebo + PFMT

Pelvic floor muscle training (PFMT) PROCEDURE

Participants in both groups will undergo PFMT training program

Beta-alanine + PFMT; Placebo + PFMT

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Palacky University: collaborator

Study Sites (1)

University hospital Olomouc

Olomouc, 77900, Czechia

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Interventions

beta-Alanine; Control Groups

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alanine; Amino Acids; Amino Acids, Peptides, and Proteins; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Vladimir Student, MD, PhD

  Dpt. of Urology, University hospital Olomouc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the study

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 28, 2021
• Study Start: February 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)