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

NCT ID: NCT04862533

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Beta-Alanine

Intervention Type DRUG

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

Pelvic floor muscle training (PFMT)

Intervention Type PROCEDURE

Participants in both groups will undergo PFMT training program

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.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Participants will receive matching placebo three times a day

Pelvic floor muscle training (PFMT)

Intervention Type PROCEDURE

Participants in both groups will undergo PFMT training program

Interventions

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Beta-Alanine

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

Intervention Type DRUG

Placebo

Participants will receive matching placebo three times a day

Intervention Type DRUG

Pelvic floor muscle training (PFMT)

Participants in both groups will undergo PFMT training program

Intervention Type PROCEDURE

Other Intervention Names

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Intervention group Control group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Palacky University

OTHER

Sponsor Role collaborator

University Hospital Olomouc

OTHER

Sponsor Role lead

Responsible Party

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Vladimir Student, M.D., Ph.D.

Director of the study

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Student, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dpt. of Urology, University hospital Olomouc

Locations

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University hospital Olomouc

Olomouc, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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URIRAPRO(2020)

Identifier Type: OTHER

Identifier Source: secondary_id

BELA2020

Identifier Type: -

Identifier Source: org_study_id