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

University Hospital Olomouc

Status: Completed

Conditions: Radical Prostatectomy; Beta-Alanine; Pelvic Floor Muscle Training; Prostate Cancer; Urinary Incontinence

Treatments: Drug: Placebo; Drug: Beta-Alanine; Procedure: Pelvic floor muscle training (PFMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04862533

URIRAPRO(2020) (Other Identifier)

BELA2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Beta-alanine + PFMT

Experimental group

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.

Treatment:

Drug: Beta-Alanine

Procedure: Pelvic floor muscle training (PFMT)

Placebo + PFMT

Experimental group

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.

Treatment:

Drug: Placebo

Procedure: Pelvic floor muscle training (PFMT)