Clinical trial · Interventional
Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy (BELA)
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)
NCT04862533CI-TRIAL-00062731BELAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Beta-Alanine | — | UNRESOLVED | — |
| Pelvic Floor Muscle Training | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radical Prostatectomy | — | UNRESOLVED | — |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Beta-Alanine | Drug | — | UNRESOLVED |
| Pelvic floor muscle training (PFMT) | Procedure | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Beta-alanine + PFMT
- 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.
- interventionNames
- Drug: Beta-Alanine
- Procedure: Pelvic floor muscle training (PFMT)
- type
- EXPERIMENTAL
- label
- Placebo + PFMT
- 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.
- interventionNames
- Drug: Placebo
- Procedure: Pelvic floor muscle training (PFMT)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available
No reference posted for this study.