Clinical trial NCT04862533: Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Urinary Incontinence
Beta-Alanine
Pelvic Floor Muscle Training
Radical Prostatectomy
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Palacky University
First posted: 2021-04-28
Enrollment: 80
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to Continence (days)
timeFrame: up to 6 months
Secondary outcomes:
measure: Assessment of physical activity of participants
timeFrame: up to 6 months
measure: Number of participants with laboratory abnormalities as measure of safety
timeFrame: up to 6 months
measure: Number of participants with adverse events
timeFrame: up to 6 months
measure: Assessment of quality of life (QoL) change in both groups of participants
timeFrame: up to 6 months
measure: Muscle carnosine concentration
timeFrame: at week 4 (surgery)
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University hospital Olomouc
Study officials:
affiliation: Dpt. of Urology, University hospital Olomouc
name: Vladimir Student, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: