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| ID | Type | Description | Link |
|---|---|---|---|
| URIRAPRO(2020) | Other Identifier | University Hospital Olomouc |
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| Name | Class |
|---|---|
| Palacky University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-Alanine | Drug | Participants will receive 1150mg of beta-alanine three times a day |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 6 months |
| Number of participants with laboratory abnormalities as measure of safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Student, MD, PhD | Dpt. of Urology, University hospital Olomouc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Olomouc | Olomouc | 77900 | Czechia |
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Parallel Assignment
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| Placebo | Drug | Participants will receive matching placebo three times a day |
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| Pelvic floor muscle training (PFMT) | Procedure | Participants in both groups will undergo PFMT training program |
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Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined |
| 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 | 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 | 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. | at week 4 (surgery) |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015091 | beta-Alanine |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000409 | Alanine |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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