Prostate Cancer, Urinary Incontinence, Beta-Alanine, Pelvic Floor Muscle Training, Radical Prostatectomy
Conditions
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.
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.
Interventions
DRUGBeta-Alanine
Participants will receive 1150mg of beta-alanine three times a day
DRUGPlacebo
Participants will receive matching placebo three times a day
PROCEDUREPelvic floor muscle training (PFMT)
Participants in both groups will undergo PFMT training program
Sponsors
Palacky University
University Hospital Olomouc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Continence (days) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of physical activity of participants | up to 6 months | 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 |
| Number of participants with laboratory abnormalities as measure of safety | up to 6 months | Number of participants with laboratory abnormalities (hematology, serum chemistry and liver function test) will be determined |
| Number of participants with adverse events | up to 6 months | 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 |
| Assessment of quality of life (QoL) change in both groups of participants | up to 6 months | 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 |
| Muscle carnosine concentration | at week 4 (surgery) | Integrity and architecture of muscle tissue will be assessed in 4 µm thick sections of formalin-fixed, paraffin-embedded, hematoxylin-eosin stained tissue samples. |
Countries
Czechia
Outcome results
None listed