Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862533
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2021-04-19
Brief Title:
Effect of Beta-alanine and Pelvic Floor Muscle Training on Urinary Incontinence After Radical Prostatectomy BELA
Sponsor:
University Hospital Olomouc
Organization:
University Hospital Olomouc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BELA
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-alanineplacebo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| URIRAPRO2020 | OTHER | University Hospital Olomouc | None |