Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 6:03 PM
Study NCT ID:
NCT04862533
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2021-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015091', 'term': 'beta-Alanine'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D000409', 'term': 'Alanine'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Continence (days)', 'timeFrame': 'up to 6 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Assessment of physical activity of participants', 'timeFrame': 'up to 6 months', 'description': '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'}, {'measure': 'Number of participants with laboratory abnormalities as measure of safety', 'timeFrame': 'up to 6 months', 'description': 'Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'up to 6 months', 'description': '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'}, {'measure': 'Assessment of quality of life (QoL) change in both groups of participants', 'timeFrame': 'up to 6 months', 'description': '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'}, {'measure': 'Muscle carnosine concentration', 'timeFrame': 'at week 4 (surgery)', 'description': 'Integrity and architecture of muscle tissue will be assessed in 4 µm thick sections of formalin-fixed, paraffin-embedded, hematoxylin-eosin stained tissue samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Urinary Incontinence', 'Beta-Alanine', 'Pelvic Floor Muscle Training', 'Radical Prostatectomy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * Age 40-80 years\n * Able to give informed consent\n * Histologically proven prostate cancer\n * BMI \\<35\n * No other cancer treatment\n * Continent\n * Good physical and mental activity\n * On normal diet\n * Scheduled for radical prostatectomy (open or robotic)\n* Exclusion Criteria:\n\n * Other malignant cancer (except for benign skin cancer)\n * Age \\> 80 years\n * Diabetes mellitus (any type)\n * Chronic bowel inflammatory disease\n * Urinary incontinence\n * Impaired mental activity\n * Previous radiotherapy of hormonal therapy\n * Vegetarian/vegan/on macrobiotic diet'}, 'identificationModule': {'nctId': 'NCT04862533', 'acronym': 'BELA', 'briefTitle': 'Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Olomouc'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'BELA2020'}, 'secondaryIdInfos': [{'id': 'URIRAPRO(2020)', 'type': 'OTHER', 'domain': 'University Hospital Olomouc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beta-alanine + PFMT', 'description': '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.', 'interventionNames': ['Drug: Beta-Alanine', 'Procedure: Pelvic floor muscle training (PFMT)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo + PFMT', 'description': '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.', 'interventionNames': ['Drug: Placebo', 'Procedure: Pelvic floor muscle training (PFMT)']}], 'interventions': [{'name': 'Beta-Alanine', 'type': 'DRUG', 'otherNames': ['Intervention group'], 'description': 'Participants will receive 1150mg of beta-alanine three times a day', 'armGroupLabels': ['Beta-alanine + PFMT']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Control group'], 'description': 'Participants will receive matching placebo three times a day', 'armGroupLabels': ['Placebo + PFMT']}, {'name': 'Pelvic floor muscle training (PFMT)', 'type': 'PROCEDURE', 'description': 'Participants in both groups will undergo PFMT training program', 'armGroupLabels': ['Beta-alanine + PFMT', 'Placebo + PFMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77900', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'University hospital Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}], 'overallOfficials': [{'name': 'Vladimir Student, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dpt. of Urology, University hospital Olomouc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Olomouc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Palacky University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the study', 'investigatorFullName': 'Vladimir Student, M.D., Ph.D.', 'investigatorAffiliation': 'University Hospital Olomouc'}}}}