Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)

Not Applicable

Completed

• Conditions: Urinary Incontinence; Prostate Cancer; Beta-Alanine; Pelvic Floor Muscle Training; Radical Prostatectomy
• Interventions: Drug: Placebo; Drug: Beta-Alanine; Procedure: Pelvic floor muscle training (PFMT)

• Registration Number: NCT04862533
• Lead Sponsor: University Hospital Olomouc

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-28
• Primary Completion: 2022-08-01
• Study Completion: 2022-10-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + PFMT	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.
Beta-alanine + PFMT	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	Placebo	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.
Beta-alanine + PFMT	Beta-Alanine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University hospital Olomouc; 🇨🇿 Olomouc, Czechia