Prostate CancerBELANCT04862533
Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)
A study testing Beta-Alanine and Pelvic floor muscle training (PFMT) in people with Prostate Cancer and Urinary Incontinence, run by University Hospital Olomouc at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence, Beta-Alanine
- What is being tested?
- Beta-Alanine and Pelvic floor muscle training (PFMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 years
- Able to give informed consent
- Histologically proven prostate cancer
- BMI <35
- No other cancer treatment
- Continent
Show all 9Show fewer
- Good physical and mental activity
- On normal diet
- Scheduled for radical prostatectomy (open or robotic)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Prostate Cancer, Urinary Incontinence, Beta-Alanine, Pelvic Floor Muscle Training, Radical Prostatectomy
- Being tested
- Beta-Alanine, Placebo, Pelvic floor muscle training (PFMT)
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-AlanineDrug
Also called Intervention group
Participants will receive 1150mg of beta-alanine three times a day
PlaceboDrug
Also called Control group
Participants will receive matching placebo three times a day
Pelvic floor muscle training (PFMT)Procedure or surgery
Participants in both groups will undergo PFMT training program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Procedure: Pelvic floor muscle training (PFMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: at week 4 (surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Feb 2020
- Primary completion1 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Principal investigator, Vladimir Student, M.D., Ph.D., University Hospital Olomouc
- Investigators
- Vladimir Student, MD, PhD, Principal investigator, Dpt. of Urology, University hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862533
- Sponsor's protocol ID
- BELA2020
- Other IDs
- URIRAPRO(2020)
- Acronym
- BELA
- Status last verified
- Dec 2022
- First submitted
- 19 Apr 2021
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04862533
- Acronym / sponsor ID
- BELA / BELA2020
- Conditions
- Prostate Cancer, Urinary Incontinence, Beta-Alanine, Pelvic Floor Muscle Training, Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Palacky University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Beta-alanine + PFMT | Experimental | Drug: Beta-Alanine, Procedure: Pelvic floor muscle training (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. |
| Placebo + PFMT | Experimental | Drug: Placebo, Procedure: Pelvic floor muscle training (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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-AlanineAlso: Intervention groupParticipants will receive 1150mg of beta-alanine three times a day | Drug | Beta-alanine + PFMT |
| PlaceboAlso: Control groupParticipants will receive matching placebo three times a day | Drug | Placebo + PFMT |
| Pelvic floor muscle training (PFMT)Participants in both groups will undergo PFMT training program | Procedure or surgery | Beta-alanine + PFMT, Placebo + PFMT |
Primary outcome
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
5 secondary outcomes
Assessment of physical activity of participants
Time frame: up to 6 months
Number of participants with laboratory abnormalities as measure of safety
Time frame: up to 6 months
Number of participants with adverse events
Time frame: up to 6 months
Assessment of quality of life (QoL) change in both groups of participants
Time frame: up to 6 months
Muscle carnosine concentration
Time frame: at week 4 (surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Student, MD, PhD principal investigator
Dpt. of Urology, University hospital Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-Alanine and Pelvic floor muscle training (PFMT) in people with Prostate Cancer and Urinary Incontinence, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Continence (days) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.